| 2026-08-11 |
Class I
|
Ongoing |
Z-3127-2026 |
Medline Convenience Kits: 1) DYNDB3086D, Catalog Number: DYNDB3086D; 2) DYNDB3100, Catalog Number: DYNDB3100; 3) DYNDH… |
— |
The kits contain certain lots of sterile applicators which may contain fungal contamination that may occur under certain environmental conditions, allowing the … |
| 2026-08-11 |
Class I
|
Ongoing |
Z-3126-2026 |
Medline Convenience Kits: 1) DYNDH1193, Catalog Number: DYNDH1193; 2) DYNDH1487A, Catalog Number: DYNDH1487A |
— |
The kits contain certain lots of sterile applicators which may contain fungal contamination that may occur under certain environmental conditions, allowing the … |
| 2026-08-11 |
Class I
|
Ongoing |
Z-3125-2026 |
Medline Convenience Kits: 1) DYKM1000B, Catalog Number: DYKM1000B; 2) DYKM2187A, Catalog Number: DYKM2187A |
— |
The kits contain certain lots of sterile applicators which may contain fungal contamination that may occur under certain environmental conditions, allowing the … |
| 2026-08-11 |
Class I
|
Ongoing |
Z-3124-2026 |
Medline Convenience Kits: 1) ACC010308A, Catalog Number: ACC010308A; 2) ACC010374A, Catalog Number: ACC010374A; 3) … |
— |
The kits contain certain lots of sterile applicators which may contain fungal contamination that may occur under certain environmental conditions, allowing the … |
| 2026-08-11 |
Class I
|
Ongoing |
Z-3123-2026 |
Medline Convenience Kits: 1) PORT ACCESS KIT UNIV OF ALA, Catalog Number: DYKM1414; 2) ARTERIAL LINE ST JOES SYR PACK… |
— |
The kits contain certain lots of sterile applicators which may contain fungal contamination that may occur under certain environmental conditions, allowing the … |
| 2026-08-11 |
Class I
|
Ongoing |
Z-3122-2026 |
Medline Convenience Kits: 1) OPEN HEART ADULT, Catalog Number: CDS840396Y; 2) FULL LINE ANEURYSM CDS, Catalog Number:… |
— |
The kits contain certain lots of sterile applicators which may contain fungal contamination that may occur under certain environmental conditions, allowing the … |
| 2026-08-11 |
Class I
|
Ongoing |
Z-3121-2026 |
Medline Convenience Kits: 1) KIT ANESTHESIA L&D A- LINE SET, Catalog Number: DYKMBNDL199A |
— |
The kits contain certain lots of sterile applicators which may contain fungal contamination that may occur under certain environmental conditions, allowing the … |
| 2026-08-10 |
Class II
|
Ongoing |
Z-3269-2026 |
Medline Convenience Kits: 1) ANTERIOR SPINE PACK, Catalog Number: DYNJT10197; 2) CRANIOTOMY #IMF 56646-LF, Catalog Nu… |
— |
The kits contain neurological sponges with the potential for unexpected variability of endotoxin levels. Potentially elevated endotoxin levels may present healt… |
| 2026-08-10 |
Class II
|
Ongoing |
Z-3268-2026 |
Medline Convenience Kits: 1) MAJOR NEURO VCH, Catalog Number: DYNJ39218I; 2) NEURO PACK-LF, Catalog Number: DYNJ41246… |
— |
The kits contain neurological sponges with the potential for unexpected variability of endotoxin levels. Potentially elevated endotoxin levels may present healt… |
| 2026-08-10 |
Class II
|
Ongoing |
Z-3267-2026 |
Medline Convenience Kits: 1) MFC CRANIOTOMY PACK, Catalog Number: DYNJT8784; 2) SLUH CRANIOTOMY PACK-LF, Catalog Numb… |
— |
The kits contain neurological sponges with the potential for unexpected variability of endotoxin levels. Potentially elevated endotoxin levels may present healt… |
| 2026-08-10 |
Class II
|
Ongoing |
Z-3266-2026 |
Medline Convenience Kits: 1) MAJOR PACK, Catalog Number: DYNJ81325A |
— |
The kits contain neurological sponges with the potential for unexpected variability of endotoxin levels. Potentially elevated endotoxin levels may present healt… |
| 2026-08-10 |
Class II
|
Ongoing |
Z-3265-2026 |
Medline Convenience Kits: 1) PEDS SINUS PACK, Catalog Number: DYNJ02516G; 2) SINUS PACK-LF, Catalog Number: DYNJ03427… |
— |
The kits contain neurological sponges with the potential for unexpected variability of endotoxin levels. Potentially elevated endotoxin levels may present healt… |
| 2026-08-10 |
Class II
|
Ongoing |
Z-3230-2026 |
Medline convenience kits containing Healthmark Instrument Channel Brushes. SINUS PACK DYNJ48258D and SINUS PACK DYNJ48… |
— |
Kits contain Healthmark Instrument Channel Brushes, which were recalled by the manufacturer due to the potential for a sharp edge/burr on the end of the brush. … |
| 2026-08-10 |
Class II
|
Ongoing |
Z-3229-2026 |
Medline convenience kits containing Healthmark Instrument Channel Brushes. SINUS PACK DYNJ48258D and Sinus Pack DYNJ4825… |
— |
Kits contain Healthmark Instrument Channel Brushes, which were recalled by the manufacturer due to the potential for a sharp edge/burr on the end of the brush. … |
| 2026-07-13 |
Class II
|
Ongoing |
Z-2993-2026 |
Medline breathing circuits labeled as: 1) MEDLINE HUDSON RCI, CIRCUIT, NEO, SING LIMB, HTD,COLUMN, Medline Product Nu… |
— |
Neonatal and infant heated wire breathing circuits may experience sporadic failure. The heated wire connector (pigtail) at the humidifier may exhibit discolorat… |
| 2026-07-13 |
Class II
|
Ongoing |
Z-2992-2026 |
Medline breathing circuits labeled as: 1) HUDSON RCI, CIRCUIT, HTD, DL, NEONATE, 48, Medline Product Number/SKU HUD78… |
— |
Neonatal and infant heated wire breathing circuits may experience sporadic failure. The heated wire connector (pigtail) at the humidifier may exhibit discolorat… |
| 2026-07-13 |
Class II
|
Ongoing |
Z-2991-2026 |
Medline Hudson RCI, DBD-CIRCUIT,VENT,INSPIRATORY,HEATED,NEO, Medline Product Number/SKU HUD78019 (Teleflex Product Numbe… |
— |
Neonatal and infant heated wire breathing circuits may experience sporadic failure. The heated wire connector (pigtail) at the humidifier may exhibit discolorat… |
| 2026-07-10 |
Class II
|
Ongoing |
Z-3029-2026 |
Medline convenience kits labeled as: 1) LAMI FUSION, Medline Kit SKU CDS982035Y; 2) NON MB MJR NEURO CRANI SM PK, M… |
— |
Kits contain a potentially contaminated component which were recalled by the manufacturer |
| 2026-07-10 |
Class II
|
Ongoing |
Z-3028-2026 |
Medline convenience kits labeled as: 1) CMH LITHO MINOR PACK-LF, Medline Kit SKU DYNJ54362F; 2) EAST MAJOR LITHOTOM… |
— |
Kits contain a potentially contaminated component which were recalled by the manufacturer |
| 2026-07-10 |
Class II
|
Ongoing |
Z-3027-2026 |
Medline convenience kits labeled as: 1) LAVH, Medline Kit SKU CDS982273U; 2) GYN ABDOMINAL CDS, Medline Kit SKU CDS… |
— |
Kits contain a potentially contaminated component which were recalled by the manufacturer |
| 2026-07-10 |
Class II
|
Ongoing |
Z-3026-2026 |
Medline convenience kits labeled as: 1) C-SECTION, Medline Kit SKU DYNJ904612L; 2) C-SECTION, Medline Kit SKU DYNJ… |
— |
Kits contain a potentially contaminated component which were recalled by the manufacturer |
| 2026-07-10 |
Class II
|
Ongoing |
Z-3025-2026 |
Medline convenience kits labeled as: 1) GYN ROBOTIC CDS, Medline Kit SKU CDS982888Q; 2) GYN ROBOTIC ADD ON PACK, Me… |
— |
Kits contain a potentially contaminated component which were recalled by the manufacturer |
| 2026-07-10 |
Class II
|
Ongoing |
Z-3024-2026 |
Medline convenience kits labeled as: 1) MAJOR GYN PACK, Medline Kit SKU DYNJG001030C; 2) GYN LITHOTOMY PACK, Medlin… |
— |
Kits contain a potentially contaminated component which were recalled by the manufacturer |
| 2026-07-10 |
Class II
|
Ongoing |
Z-3023-2026 |
Medline convenience kits labeled as: LTP CDS-LF, Medline kit SKU CDS980375M |
— |
Kits contain a potentially contaminated component which were recalled by the manufacturer |
| 2026-07-10 |
Class II
|
Ongoing |
Z-3022-2026 |
Medline convenience kits labeled as: 1) MAJOR PROCEDURE, Medline Kit SKU CDS982040U; 2) OPERATIVE LAP P&S SURGICAL,… |
— |
Kits contain a potentially contaminated component which were recalled by the manufacturer |
| 2026-07-10 |
Class II
|
Ongoing |
Z-3021-2026 |
Medline convenience kits labeled as: MAJOR HEAD AND NECK PPS, Medline Kit SKU DYNJ9425991S |
— |
Kits contain a potentially contaminated component which were recalled by the manufacturer |
| 2026-07-10 |
Class II
|
Ongoing |
Z-3020-2026 |
Medline convenience kits labeled as: 1) OPEN HEART PACK, Medline Kit SKU CDS840393P; 2) OPEN HEART PACK, Medline Ki… |
— |
Kits contain a potentially contaminated component which were recalled by the manufacturer |
| 2026-07-10 |
Class II
|
Ongoing |
Z-3019-2026 |
Medline convenience kits labeled as: 1) FEMORAL PACK, Medline Kit SKU DYNJ909393A; 2) FEVAR, Medline Kit SKU DYNJ91… |
— |
Kits contain a potentially contaminated component which were recalled by the manufacturer |
| 2026-07-10 |
Class II
|
Ongoing |
Z-2999-2026 |
Medline medical convenience kit labeled as: TRACH TUBE KIT, Medline Kit SKU DYKM2330 |
— |
Component labeling discrepancy |
| 2026-07-08 |
Class II
|
Ongoing |
Z-2997-2026 |
Medline medical convenience kits, labeled as: 1) LAMINECTOMY PACK, Medline Kit SKU DYNJT6548; 2) ORTHO SPINE PACK, … |
— |
Specific item(s) and lot(s) of Medline convenience kits containing Pilling Wecksorb Neurosponges and Neurosponge Strips are being recalled due to potential out-… |
| 2026-07-08 |
Class II
|
Ongoing |
Z-2996-2026 |
Medline medical convenience kits, labeled as: 1) NEURO CDS, Medline Kit SKU CDS985246J; 2) NEURO PACK, Medline Kit … |
— |
Specific item(s) and lot(s) of Medline convenience kits containing Pilling Wecksorb Neurosponges and Neurosponge Strips are being recalled due to potential out-… |
| 2026-07-08 |
Class II
|
Ongoing |
Z-2995-2026 |
Medline medical convenience kits, labeled as: 1) CRANIOTOMY PACK, Medline Kit SKU DYNJT6545; 2) ORTHO SPINE PACK, M… |
— |
Specific item(s) and lot(s) of Medline convenience kits containing Pilling Wecksorb Neurosponges and Neurosponge Strips are being recalled due to potential out-… |
| 2026-07-08 |
Class II
|
Ongoing |
Z-2994-2026 |
Medline medical convenience kits, labeled as: 1) SINUS PACK-LF, Medline Kit SKU DYNJ0966146F; 2) ENT PACK, Medline … |
— |
Specific item(s) and lot(s) of Medline convenience kits containing Pilling Wecksorb Neurosponges and Neurosponge Strips are being recalled due to potential out-… |
| 2026-06-10 |
Class II
|
Ongoing |
Z-2737-2026 |
Medline Kits containing Zimmer Biomet mixing bowls and spatulas TOTAL KNEE PACK-LF DYNJ61651J |
— |
Kits contain Zimmer Biomet mixing bowls and spatulas, which were recalled due to seal nonconformities which present risk of sterility breach. Health consequence… |
| 2026-06-10 |
Class II
|
Ongoing |
Z-2736-2026 |
Medline Kits containing Zimmer Biomet mixing bowls and spatulas TOTAL KNEE PACK DYNJT6267 |
— |
Kits contain Zimmer Biomet mixing bowls and spatulas, which were recalled due to seal nonconformities which present risk of sterility breach. Health consequence… |
| 2026-05-28 |
Class II
|
Ongoing |
Z-2613-2026 |
Medline Convenience kits containing recalled Swan-Ganz Catheters CABG A CDS CDS982269K CDS982269L CDS982269M … |
— |
Kits contain Swan-Ganz catheters recalled by Becton Dickinson (BD). BD has received complaints of leaks/breakage involving failures of the (blue) proximal injec… |
| 2026-05-28 |
Class II
|
Ongoing |
Z-2612-2026 |
Medline Convenience kits containing recalled Swan-Ganz Catheters RIGHT HEART CATH PACK CTX DYNJ68530A |
— |
Kits contain Swan-Ganz catheters recalled by Becton Dickinson (BD). BD has received complaints of leaks/breakage involving failures of the (blue) proximal injec… |
| 2026-05-28 |
Class II
|
Ongoing |
Z-2611-2026 |
Medline Convenience kits containing recalled Swan-Ganz Catheters OPEN HEART DYNJ909090B OPEN HEART CDS QVH C… |
— |
Kits contain Swan-Ganz catheters recalled by Becton Dickinson (BD). BD has received complaints of leaks/breakage involving failures of the (blue) proximal injec… |
| 2026-05-28 |
Class II
|
Ongoing |
Z-2610-2026 |
Medline Convenience kits containing recalled Swan-Ganz Catheters CV ANESTHESIA - ROOM SET UP DYNJ905503D DYNJ905… |
— |
Kits contain Swan-Ganz catheters recalled by Becton Dickinson (BD). BD has received complaints of leaks/breakage involving failures of the (blue) proximal injec… |
| 2026-05-28 |
Class II
|
Ongoing |
Z-2609-2026 |
Medline Convenience kits containing recalled Swan-Ganz Catheters KIT GERMANTOWN CABG DYNJ905855 KIT UNIVERSITY… |
— |
Kits contain Swan-Ganz catheters recalled by Becton Dickinson (BD). BD has received complaints of leaks/breakage involving failures of the (blue) proximal injec… |
| 2026-05-28 |
Class II
|
Ongoing |
Z-2608-2026 |
Medline Convenience kits containing recalled Swan-Ganz Catheters CENTRAL AND ARTERIAL LINE TOTE DYNJ8407 |
— |
Kits contain Swan-Ganz catheters recalled by Becton Dickinson (BD). BD has received complaints of leaks/breakage involving failures of the (blue) proximal injec… |
| 2026-05-28 |
Class II
|
Ongoing |
Z-2607-2026 |
Medline Convenience kits containing recalled Swan-Ganz Catheters CARDIAC MAJOR DYNJ901328G HEART A DYNJ903… |
— |
Kits contain Swan-Ganz catheters recalled by Becton Dickinson (BD). BD has received complaints of leaks/breakage involving failures of the (blue) proximal injec… |
| 2026-05-28 |
Class II
|
Ongoing |
Z-2606-2026 |
Medline Convenience kits containing recalled Swan-Ganz Catheters RIGHT HEART CATH PACK CTX DYNJ68530B |
— |
Kits contain Swan-Ganz catheters recalled by Becton Dickinson (BD). BD has received complaints of leaks/breakage involving failures of the (blue) proximal injec… |
| 2026-05-04 |
Class II
|
Ongoing |
Z-2508-2026 |
MEDLINE Medical Procedure Kits labeled as: 1) CRANI, Medline Kit Number/SKU DYNJ908097; 2) CRANI, Medline Kit Numbe… |
— |
During an internal review, Medline identified representative samples did not meet applicable performance specifications. Identified issues include irregularitie… |
| 2026-05-04 |
Class II
|
Ongoing |
Z-2507-2026 |
MEDLINE Medical Procedure Kits labeled as: 1) RETINA LAC/USC CDS, Medline Kit Number/SKU CDS983775I; 2) RETINA LAC/… |
— |
During an internal review, Medline identified representative samples did not meet applicable performance specifications. Identified issues include irregularitie… |
| 2026-05-04 |
Class II
|
Ongoing |
Z-2506-2026 |
MEDLINE Medical Procedure Kits labeled as: KIT URO ROBOT CYSTECTOMY, D AND C PACK, MAD D & C, VPH LITHOTOMY MINOR, TR… |
— |
During an internal review, Medline identified representative samples did not meet applicable performance specifications. Identified issues include irregularitie… |
| 2026-05-04 |
Class II
|
Ongoing |
Z-2505-2026 |
MEDLINE Medical Procedure Kits labeled as CLOVIS HYSTEROSCOPY, CSC-N PELVISCOPY, D AND C PACK, D&C HYSTER PACK, FLWR GYN… |
— |
During an internal review, Medline identified representative samples did not meet applicable performance specifications. Identified issues include irregularitie… |
| 2026-05-04 |
Class II
|
Ongoing |
Z-2504-2026 |
MEDLINE Medical Procedure Kits labeled as: 1) D AND C PACK, Medline Kit Number/SKU DYNJ53973C; 2) PK CUST CV A&B CA… |
— |
During an internal review, Medline identified representative samples did not meet applicable performance specifications. Identified issues include irregularitie… |
| 2026-05-04 |
Class II
|
Ongoing |
Z-2503-2026 |
MEDLINE Medical Procedure Kits labeled as BASIC GYN, CW LAP GYN, D&C HYSTEROSCOPY, CW LAP GYN, DEACONESS PELVIC LAP PA… |
— |
During an internal review, Medline identified representative samples did not meet applicable performance specifications. Identified issues include irregularitie… |
| 2026-05-04 |
Class II
|
Ongoing |
Z-2502-2026 |
MEDLINE Medical Procedure Kits labeled as: PELVIC LAP PACK, Medline Kit Number/ SKU DYNJ53820B |
— |
During an internal review, Medline identified representative samples did not meet applicable performance specifications. Identified issues include irregularitie… |
| 2026-05-04 |
Class II
|
Ongoing |
Z-2501-2026 |
MEDLINE Medical Procedure Kits labeled as: 1) BR L&D PACK, Medline Kit Number/SKU DYNJ47625B; 2) GYN VAGINAL, Medli… |
— |
During an internal review, Medline identified representative samples did not meet applicable performance specifications. Identified issues include irregularitie… |
| 2026-05-04 |
Class II
|
Ongoing |
Z-2500-2026 |
MEDLINE Medical Procedure Kits labeled as: 1) CAROTID NEURO PACK, Medline Kit Number/SKU DYNJ44926G; 2) VP SHUNT CD… |
— |
During an internal review, Medline identified representative samples did not meet applicable performance specifications. Identified issues include irregularitie… |
| 2026-05-04 |
Class II
|
Ongoing |
Z-2499-2026 |
MEDLINE Medical Procedure Kits labeled as: NURSING KIT, Medline Kit Number/SKU EDUC1044 |
— |
During an internal review, Medline identified representative samples did not meet applicable performance specifications. Identified issues include irregularitie… |
| 2026-05-04 |
Class II
|
Ongoing |
Z-2498-2026 |
MEDLINE Medical Procedure Kits labeled as: DR FERNANDEZ, Medline kit number/SKU DYNJ68808 |
— |
During an internal review, Medline identified representative samples did not meet applicable performance specifications. Identified issues include irregularitie… |
| 2026-05-04 |
Class II
|
Ongoing |
Z-2497-2026 |
MEDLINE Medical Procedure Kits labeled as BIOBURDEN TEST KIT, Kit Uro Robot Cystectomy, etc. (see the recall documents f… |
— |
During an internal review, Medline identified representative samples did not meet applicable performance specifications. Identified issues include irregularitie… |
| 2026-05-04 |
Class II
|
Ongoing |
Z-2496-2026 |
MEDLINE Medical Procedure Kits labeled as: 1) CV DRAPING/BASIN, Medline Kit Number/SKU DYNJ908483A; 2) CV DRAPING/B… |
— |
During an internal review, Medline identified representative samples did not meet applicable performance specifications. Identified issues include irregularitie… |
| 2026-05-04 |
Class II
|
Ongoing |
Z-2495-2026 |
MEDLINE Medical Procedure Kits labeled as: 1) KIT UROLOGY URETHROPLASTY, Medline Kit Number/SKU DYKMBNDL117C; 2) UR… |
— |
During an internal review, Medline identified representative samples did not meet applicable performance specifications. Identified issues include irregularitie… |
| 2026-05-04 |
Class II
|
Ongoing |
Z-2494-2026 |
MEDLINE Medical Procedure Kits labeled as: TONSIL PACK CATH, Medline Kit Number/SKU DYNJ65199A |
— |
During an internal review, Medline identified representative samples did not meet applicable performance specifications. Identified issues include irregularitie… |
| 2026-05-04 |
Class II
|
Ongoing |
Z-2493-2026 |
MEDLINE Medical Procedure Kits labeled as: 1) CHEST EXPLORATION ECMO, Medline Kit Number/SKU DYNJ63789A; 2) CORONAR… |
— |
During an internal review, Medline identified representative samples did not meet applicable performance specifications. Identified issues include irregularitie… |
| 2026-05-04 |
Class II
|
Ongoing |
Z-2492-2026 |
MEDLINE Medical Procedure Kits labeled as: CATH 22F ROBINSON STRL 5'S PK, Medline Kit Number/SKU DYNJ0040839 |
— |
During an internal review, Medline identified representative samples did not meet applicable performance specifications. Identified issues include irregularitie… |
| 2026-05-04 |
Class II
|
Ongoing |
Z-2491-2026 |
MEDLINE Medical Procedure Kits labeled as: ADULT TRACHEOSTOMY TUBE INSERT, ASC T&A, CONWAY T&A SINUS, EAR PACK, etc. … |
— |
During an internal review, Medline identified representative samples did not meet applicable performance specifications. Identified issues include irregularitie… |
| 2026-05-04 |
Class II
|
Ongoing |
Z-2490-2026 |
MEDLINE Medical Procedure Kits labeled as: ORAL RESTORATION, Medline Kit Number/SKUDYNJ86253A |
— |
During an internal review, Medline identified representative samples did not meet applicable performance specifications. Identified issues include irregularitie… |
| 2026-05-04 |
Class II
|
Ongoing |
Z-2489-2026 |
MEDLINE Medical Procedure Kits labeled as: BILAT MICRO VASECTOMY REVERSAL, Medline Kit Number/SKU DYNJ68302 |
— |
During an internal review, Medline identified representative samples did not meet applicable performance specifications. Identified issues include irregularitie… |
| 2026-05-04 |
Class II
|
Ongoing |
Z-2488-2026 |
MEDLINE Medical Procedure Kits labeled as: 1) BNT CV PACK, Medline Kit Number/SKU DYNJ912271; 2) CV PACK PART 1, Me… |
— |
During an internal review, Medline identified representative samples did not meet applicable performance specifications. Identified issues include irregularitie… |
| 2026-05-04 |
Class II
|
Ongoing |
Z-2487-2026 |
MEDLINE Medical Procedure Kits labeled as CH OPEN HEART, ADULT CARDIAC KIT, AHT CVOR CABG, APH EMERGENCY OPEN HEART PACK… |
— |
During an internal review, Medline identified representative samples did not meet applicable performance specifications. Identified issues include irregularitie… |
| 2026-05-04 |
Class II
|
Ongoing |
Z-2486-2026 |
MEDLINE Medical Procedure Kits labeled as: 1) BASIC HEART PACK, Medline Kit/SKU DYNJ67331B; 2) CARDIAC SURGERY, Med… |
— |
During an internal review, Medline identified representative samples did not meet applicable performance specifications. Identified issues include irregularitie… |
| 2026-05-04 |
Class II
|
Ongoing |
Z-2485-2026 |
MEDLINE Medical Procedure Kits labeled as: LAPAROSCOPY COMBINED - NO NDL, Medline Kit Number/SKU DYNJ37378A |
— |
During an internal review, Medline identified representative samples did not meet applicable performance specifications. Identified issues include irregularitie… |
| 2026-05-04 |
Class II
|
Ongoing |
Z-2484-2026 |
MEDLINE Intermittent Latex Catheter Coude Pre-Connected to Collection Bag, 16 Fr, 1000mL, Medline Product Number/SKU (RE… |
— |
During an internal review, Medline identified representative samples did not meet applicable performance specifications. Identified issues include irregularitie… |
| 2026-05-04 |
Class II
|
Ongoing |
Z-2483-2026 |
MEDLINE Intermittent Latex Catheter Coude Pre-Connected to Collection Bag, 14 Fr, 1000mL, Medline Product Number/SKU (RE… |
— |
During an internal review, Medline identified representative samples did not meet applicable performance specifications. Identified issues include irregularitie… |
| 2026-05-04 |
Class II
|
Ongoing |
Z-2482-2026 |
MEDLINE Urethral Catheterization Tray and Bag, Red Rubber Latex, 15 Fr, Medline Product Number/SKU (REF) DYND18350 |
— |
During an internal review, Medline identified representative samples did not meet applicable performance specifications. Identified issues include irregularitie… |
| 2026-05-04 |
Class II
|
Ongoing |
Z-2481-2026 |
MEDLINE Pre-connected Urethral Catheterization Tray and Bag, Red Rubber Latex, 15 Fr, Medline Product Number/SKU (REF) D… |
— |
During an internal review, Medline identified representative samples did not meet applicable performance specifications. Identified issues include irregularitie… |
| 2026-05-04 |
Class II
|
Ongoing |
Z-2480-2026 |
MEDLINE Urethral Catheterization Tray, Red Rubber Latex, Medline Product Number/SKU (REF), French sizes: 1. DYNC1816,… |
— |
During an internal review, Medline identified representative samples did not meet applicable performance specifications. Identified issues include irregularitie… |
| 2026-05-04 |
Class II
|
Ongoing |
Z-2479-2026 |
MEDLINE Urethral Catheter, Red Rubber Latex, Medline Product Number/SKU (REF), French sizes: 1. DYND13508 - 08 Fr; 2… |
— |
During an internal review, Medline identified representative samples did not meet applicable performance specifications. Identified issues include irregularitie… |
| 2026-03-24 |
Class I
|
Ongoing |
Z-2148-2026 |
Medline medical convenience kits, containing Namic Manifold, Labeled as: TAVI, Medline Kit Number/SKU DYNJ904981C |
— |
Medline has identified the presence of particulate within the fluid path of the Manifolds. |
| 2026-03-24 |
Class I
|
Ongoing |
Z-2147-2026 |
Medline medical convenience kits, containing Namic Manifold, Labeled as: 1. MTS,RT,HANDED/LFT,HRT,KIT, Medline Kit Nu… |
— |
Medline has identified the presence of particulate within the fluid path of the Manifolds. |
| 2026-03-24 |
Class I
|
Ongoing |
Z-2146-2026 |
Medline medical convenience kits, containing Namic Manifold, Labeled as: HEART CATH PACK-LF, Medline Kit Number/SKU DYN… |
— |
Medline has identified the presence of particulate within the fluid path of the Manifolds. |
| 2026-03-24 |
Class I
|
Ongoing |
Z-2145-2026 |
1. 3 VALVE MAN KIT, Medline Kit SKU Number: 65101544; 2. 3V MANIFOLD KIT, Medline Kit SKU Number: 65110351; 3. HEA… |
— |
Medline has identified the presence of particulate within the fluid path of the Manifolds. |
| 2026-03-24 |
Class I
|
Ongoing |
Z-2144-2026 |
1. DBD-MTS,3V,MAN,KIT, Medline Kit Number/SKU 60010195; 2. MTS-LEFT HEART,KIT, Medline Kit Number/SKU 60033123; 3. M… |
— |
Medline has identified the presence of particulate within the fluid path of the Manifolds. |
| 2026-03-24 |
Class I
|
Ongoing |
Z-2143-2026 |
Medline medical convenience kits, containing Namic Manifold, Labeled as: 1. ANGIOGRAPHY CATH LAB, Medline Kit Number/… |
— |
Medline has identified the presence of particulate within the fluid path of the Manifolds. |
| 2026-03-24 |
Class I
|
Ongoing |
Z-2142-2026 |
Namic Preceptor Manifold, custom, Medline Product Number/SKU 64039307; Extravascular blood pressure transducer |
— |
Medline has identified the presence of particulate within the fluid path of the Manifolds. |
| 2026-03-24 |
Class I
|
Ongoing |
Z-2141-2026 |
Namic Preceptor Manifold, custom, Medline Product Number/SKU 64037107; Extravascular blood pressure transducer |
— |
Medline has identified the presence of particulate within the fluid path of the Manifolds. |
| 2026-03-24 |
Class I
|
Ongoing |
Z-2140-2026 |
Namic Angiographic Manifold, custom, Medline Product Number/SKU 64038402; Cardiopulmonary bypass adaptor, stopcock, mani… |
— |
Medline has identified the presence of particulate within the fluid path of the Manifolds. |
| 2026-03-24 |
Class I
|
Ongoing |
Z-2139-2026 |
Namic Angiographic Manifold, custom, Medline Product Number/SKU 64038301; Cardiopulmonary bypass adaptor, stopcock, mani… |
— |
Medline has identified the presence of particulate within the fluid path of the Manifolds. |
| 2026-03-24 |
Class I
|
Ongoing |
Z-2138-2026 |
Namic Angiographic Manifold, custom, Medline Product Number/SKU 64038200; Cardiopulmonary bypass adaptor, stopcock, mani… |
— |
Medline has identified the presence of particulate within the fluid path of the Manifolds. |
| 2026-03-19 |
Class II
|
Ongoing |
Z-2038-2026 |
Medline medical procedure kits, containing Medline Neuro Sponges (4077 in total), LAMINECTOMY, CRANI, etc. |
— |
During an internal review, Medline identified higher-than-expected endotoxin levels on a representative Medline neuro sponge product, indicating that in-market … |
| 2026-03-19 |
Class II
|
Ongoing |
Z-2037-2026 |
Medline medical procedure kits, containing Medline Neuro Sponges, labeled as follows: 1. CATARACT PACK, Medline Kit Nu… |
— |
During an internal review, Medline identified higher-than-expected endotoxin levels on a representative Medline neuro sponge product, indicating that in-market … |
| 2026-03-19 |
Class II
|
Ongoing |
Z-2036-2026 |
Medline medical procedure kits, containing Medline Neuro Sponges, labeled as follows: 1. ANTERIOR CERVICAL FUSION PACK… |
— |
During an internal review, Medline identified higher-than-expected endotoxin levels on a representative Medline neuro sponge product, indicating that in-market … |
| 2026-03-19 |
Class II
|
Ongoing |
Z-2035-2026 |
Medline medical procedure kits, containing Medline Neuro Sponges, labeled as follows: 1. ROBOTIC HYSTERECTOMY, Medlin… |
— |
During an internal review, Medline identified higher-than-expected endotoxin levels on a representative Medline neuro sponge product, indicating that in-market … |
| 2026-03-19 |
Class II
|
Ongoing |
Z-2034-2026 |
Medline medical procedure kits, containing Medline Neuro Sponges, labeled as follows: 1. SPINE PROCEDURES PACK-LF, Medli… |
— |
During an internal review, Medline identified higher-than-expected endotoxin levels on a representative Medline neuro sponge product, indicating that in-market … |
| 2026-03-19 |
Class II
|
Ongoing |
Z-2033-2026 |
Medline medical procedure kits, containing Medline Neuro Sponges (961 in total), NEURO, |
— |
During an internal review, Medline identified higher-than-expected endotoxin levels on a representative Medline neuro sponge product, indicating that in-market … |
| 2026-03-19 |
Class II
|
Ongoing |
Z-2032-2026 |
Medline medical procedure kits, containing Medline Neuro Sponges, labeled as follows: SPNG NEURO 1X1 10/PK XR, Medline K… |
— |
During an internal review, Medline identified higher-than-expected endotoxin levels on a representative Medline neuro sponge product, indicating that in-market … |
| 2026-03-19 |
Class II
|
Ongoing |
Z-2031-2026 |
Medline medical procedure kits, containing Medline Neuro Sponges, labeled as follows: GENERAL KIT, Medline Kit Number/S… |
— |
During an internal review, Medline identified higher-than-expected endotoxin levels on a representative Medline neuro sponge product, indicating that in-market … |
| 2026-03-19 |
Class II
|
Ongoing |
Z-2030-2026 |
Medline medical procedure kits, containing Medline Neuro Sponges, labeled as follows: 1. MICRODISECTOMY PACK, Medline… |
— |
During an internal review, Medline identified higher-than-expected endotoxin levels on a representative Medline neuro sponge product, indicating that in-market … |
| 2026-03-19 |
Class II
|
Ongoing |
Z-2029-2026 |
Medline medical procedure kits, containing Medline Neuro Sponges, labeled as follows: CERVICAL PACK, Medline Kit Number… |
— |
During an internal review, Medline identified higher-than-expected endotoxin levels on a representative Medline neuro sponge product, indicating that in-market … |
| 2026-03-19 |
Class II
|
Ongoing |
Z-2028-2026 |
Centurion medical procedure kits, containing Medline Neuro Sponges, labeled as follows: SURGICAL ENT PREP KIT, Medline … |
— |
During an internal review, Medline identified higher-than-expected endotoxin levels on a representative Medline neuro sponge product, indicating that in-market … |
| 2026-03-19 |
Class II
|
Ongoing |
Z-2027-2026 |
Medline medical procedure kits, containing Medline Neuro Sponges (1050 in total), BIOBURDEN TEST KIT, NEURO, ROBOTIC, AC… |
— |
During an internal review, Medline identified higher-than-expected endotoxin levels on a representative Medline neuro sponge product, indicating that in-market … |
| 2026-03-19 |
Class II
|
Ongoing |
Z-2026-2026 |
Medline medical procedure kits, containing Medline Neuro Sponges, labeled as follows: 1. NEURO BASIN PACK-LF, Medline… |
— |
During an internal review, Medline identified higher-than-expected endotoxin levels on a representative Medline neuro sponge product, indicating that in-market … |
| 2026-03-19 |
Class II
|
Ongoing |
Z-2025-2026 |
Medline medical procedure kits, containing Medline Neuro Sponges (102 in total) |
— |
During an internal review, Medline identified higher-than-expected endotoxin levels on a representative Medline neuro sponge product, indicating that in-market … |
| 2026-03-19 |
Class II
|
Ongoing |
Z-2024-2026 |
Medline medical procedure kits, containing Medline Neuro Sponges, labeled as follows: 1. ENDOSCOPY-LF, Medline Kit N… |
— |
During an internal review, Medline identified higher-than-expected endotoxin levels on a representative Medline neuro sponge product, indicating that in-market … |
| 2026-03-19 |
Class II
|
Ongoing |
Z-2023-2026 |
Medline medical procedure kits, containing Medline Neuro Sponges, labeled as follows: 1. ENDOSCOPIC SKULL BASE, Medlin… |
— |
During an internal review, Medline identified higher-than-expected endotoxin levels on a representative Medline neuro sponge product, indicating that in-market … |
| 2026-03-19 |
Class II
|
Ongoing |
Z-2022-2026 |
Medline medical procedure kits, containing Medline Neuro Sponges, labeled as follows: 1. PLASTICS FREE FLAP, Medline … |
— |
During an internal review, Medline identified higher-than-expected endotoxin levels on a representative Medline neuro sponge product, indicating that in-market … |
| 2026-03-19 |
Class II
|
Ongoing |
Z-2021-2026 |
Medline and Centurion medical procedure kits, containing Medline Neuro Sponges (1229 in total), HEAD & NECK TRAY, SINUS,… |
— |
During an internal review, Medline identified higher-than-expected endotoxin levels on a representative Medline neuro sponge product, indicating that in-market … |
| 2026-03-19 |
Class II
|
Ongoing |
Z-2020-2026 |
Medline medical procedure kits, containing Medline Neuro Sponges, labeled as follows: 1. ZALE STEREOTACTIC CDS, Medli… |
— |
During an internal review, Medline identified higher-than-expected endotoxin levels on a representative Medline neuro sponge product, indicating that in-market … |
| 2026-03-19 |
Class II
|
Ongoing |
Z-2019-2026 |
Medline medical procedure kits, containing Medline Neuro Sponges, labeled as follows: 1. RR-OMFS PACK-LF, Medline Kit… |
— |
During an internal review, Medline identified higher-than-expected endotoxin levels on a representative Medline neuro sponge product, indicating that in-market … |
| 2026-03-19 |
Class II
|
Ongoing |
Z-2018-2026 |
Medline medical procedure kits, containing Medline Neuro Sponges, labeled as follows: 1. OSC COLEMAN FAT HARVEST KIT,… |
— |
During an internal review, Medline identified higher-than-expected endotoxin levels on a representative Medline neuro sponge product, indicating that in-market … |
| 2026-03-19 |
Class II
|
Ongoing |
Z-2017-2026 |
Medline medical procedure kits, containing Medline Neuro Sponges, labeled as follows: 1. VP SHUNT, Medline Kit Number… |
— |
During an internal review, Medline identified higher-than-expected endotoxin levels on a representative Medline neuro sponge product, indicating that in-market … |
| 2026-03-19 |
Class II
|
Ongoing |
Z-2016-2026 |
Medline medical procedure kits, containing Medline Neuro Sponges, labeled as follows: 1. OPEN HEART CDS PART A, Medli… |
— |
During an internal review, Medline identified higher-than-expected endotoxin levels on a representative Medline neuro sponge product, indicating that in-market … |
| 2026-03-19 |
Class II
|
Ongoing |
Z-2015-2026 |
Medline medical procedure kits, containing Medline Neuro Sponges, labeled as follows: 1. MAJOR NEURO PACK-LF, Medline… |
— |
During an internal review, Medline identified higher-than-expected endotoxin levels on a representative Medline neuro sponge product, indicating that in-market … |
| 2026-03-19 |
Class II
|
Ongoing |
Z-2014-2026 |
Medline medical procedure kits, containing Medline Neuro Sponges, labeled as follows: ANGIO PACK-LF, Medline Kit Number/… |
— |
During an internal review, Medline identified higher-than-expected endotoxin levels on a representative Medline neuro sponge product, indicating that in-market … |
| 2026-03-19 |
Class II
|
Ongoing |
Z-2013-2026 |
Medline medical procedure kits, containing Medline Neuro Sponges, labeled as follows: 1. NEURO PACK, Medline kit numb… |
— |
During an internal review, Medline identified higher-than-expected endotoxin levels on a representative Medline neuro sponge product, indicating that in-market … |
| 2026-03-19 |
Class II
|
Ongoing |
Z-2012-2026 |
Medline medical procedure kits, containing Medline Neuro Sponges, labeled as follows: SPINE PACK-LF, Medline Kit Number… |
— |
During an internal review, Medline identified higher-than-expected endotoxin levels on a representative Medline neuro sponge product, indicating that in-market … |
| 2026-03-19 |
Class II
|
Ongoing |
Z-2011-2026 |
Medline medical procedure kits, containing Medline Neuro Sponges, labeled as follows: SPINAL FUSION, Medline Kit Number… |
— |
During an internal review, Medline identified higher-than-expected endotoxin levels on a representative Medline neuro sponge product, indicating that in-market … |
| 2026-03-19 |
Class II
|
Ongoing |
Z-2010-2026 |
Medline medical procedure kits, containing Medline Neuro Sponges, labeled as follows: EH BRONCHOSCOPY, Medline Kit Numbe… |
— |
During an internal review, Medline identified higher-than-expected endotoxin levels on a representative Medline neuro sponge product, indicating that in-market … |
| 2026-03-19 |
Class II
|
Ongoing |
Z-2009-2026 |
Medline medical procedure kits, containing Medline Neuro Sponges, labeled as follows: PEDS AIRWAY PACK, Medline Kit Num… |
— |
During an internal review, Medline identified higher-than-expected endotoxin levels on a representative Medline neuro sponge product, indicating that in-market … |
| 2026-03-19 |
Class II
|
Ongoing |
Z-2008-2026 |
Medline Neuro Sponges, various dimensions, labeled as: 1. Neuro Sponges, Eponges neuro, Neuroesponjas, size 0.25" … |
— |
During an internal review, Medline identified higher-than-expected endotoxin levels on a representative Medline neuro sponge product, indicating that in-market … |
| 2026-03-16 |
Class II
|
Ongoing |
Z-2045-2026 |
Medline and Centurion medical convenience kits, containing Webcol Large Alcohol Prep Pads, labeled as: 1. LVAD DRIVEL… |
— |
Medline Industries, LP is issuing a recall for specific item(s) and lot(s) of Medline Kits containing Cardinal Health Webcol Large Alcohol Prep Pads. Cardinal H… |
| 2026-03-16 |
Class II
|
Ongoing |
Z-2044-2026 |
Centurion medical convenience kits, containing Webcol Large Alcohol Prep Pads, labeled as: DERMATOLOGY SHAVE KIT, Medli… |
— |
Medline Industries, LP is issuing a recall for specific item(s) and lot(s) of Medline Kits containing Cardinal Health Webcol Large Alcohol Prep Pads. Cardinal H… |
| 2026-03-16 |
Class II
|
Ongoing |
Z-2043-2026 |
Medline or Centurion medical convenience kits, containing Webcol Large Alcohol Prep Pads, labeled as: 1. NEONATAL IV … |
— |
Medline Industries, LP is issuing a recall for specific item(s) and lot(s) of Medline Kits containing Cardinal Health Webcol Large Alcohol Prep Pads. Cardinal H… |
| 2026-03-16 |
Class II
|
Ongoing |
Z-2042-2026 |
Centurion medical convenience kits, containing Webcol Large Alcohol Prep Pads, labeled as: LATEX FREE GENERAL PURPOSE T… |
— |
Medline Industries, LP is issuing a recall for specific item(s) and lot(s) of Medline Kits containing Cardinal Health Webcol Large Alcohol Prep Pads. Cardinal H… |
| 2026-03-16 |
Class II
|
Ongoing |
Z-2041-2026 |
Medline and Centurion medical convenience kits, containing Webcol Large Alcohol Prep Pads, labeled as: 1. FOLEY CARE … |
— |
Medline Industries, LP is issuing a recall for specific item(s) and lot(s) of Medline Kits containing Cardinal Health Webcol Large Alcohol Prep Pads. Cardinal H… |
| 2026-03-16 |
Class II
|
Ongoing |
Z-2040-2026 |
Medline medical convenience kits, containing Webcol Large Alcohol Prep Pads, labeled as: 1. BLOOD CULTURE KIT, Medline… |
— |
Medline Industries, LP is issuing a recall for specific item(s) and lot(s) of Medline Kits containing Cardinal Health Webcol Large Alcohol Prep Pads. Cardinal H… |
| 2026-03-16 |
Class II
|
Ongoing |
Z-2039-2026 |
Centurion medical convenience kits, containing Webcol Large Alcohol Prep Pads, labeled as: Universal Central/Art Line I… |
— |
Medline Industries, LP is issuing a recall for specific item(s) and lot(s) of Medline Kits containing Cardinal Health Webcol Large Alcohol Prep Pads. Cardinal H… |
| 2026-03-16 |
Class II
|
Ongoing |
Z-1824-2026 |
CENTURION Circumcision Kit, Medline Kit Number/SKU CIT7050F |
— |
On lot of Sterile Circumcision Kits was distributed without the required sterilization process and is therefore not sterile. |
| 2026-02-27 |
Class II
|
Ongoing |
Z-1892-2026 |
Medline Convenience Kits containing select SKUs of 10mL Polycarbonate Colored Syringes ENSEMBLE GYNECO SCOPIE-LF DYNJ… |
— |
Unapproved design changes to the products outside of the 510(k) clearance. |
| 2026-02-27 |
Class II
|
Ongoing |
Z-1891-2026 |
Medline Convenience Kits containing select SKUs of 10mL Polycarbonate Colored Syringes ARTERIOGRAM TRAY 00-402001T, 0… |
— |
Unapproved design changes to the products outside of the 510(k) clearance. |
| 2026-02-27 |
Class II
|
Ongoing |
Z-1890-2026 |
Medline Convenience Kits containing select SKUs of 10mL Polycarbonate Colored Syringes ADD A ENDOVASCULAR PACK-LF DYN… |
— |
Unapproved design changes to the products outside of the 510(k) clearance. |
| 2026-02-27 |
Class II
|
Ongoing |
Z-1889-2026 |
Medline Convenience Kits containing select SKUs of 10mL Polycarbonate Colored Syringes E P DRAPE PACK-LF DYNJ0373061J |
— |
Unapproved design changes to the products outside of the 510(k) clearance. |
| 2026-02-27 |
Class II
|
Ongoing |
Z-1888-2026 |
Medline Convenience Kits containing select SKUs of 10mL Polycarbonate Colored Syringes ARTHROSCOPY PACK DYNJ45173D |
— |
Unapproved design changes to the products outside of the 510(k) clearance. |
| 2026-02-27 |
Class II
|
Ongoing |
Z-1887-2026 |
Medline Convenience Kits containing select SKUs of 10mL Polycarbonate Colored Syringes EXTREMITY PACK DYNJ34846C … |
— |
Unapproved design changes to the products outside of the 510(k) clearance. |
| 2026-02-27 |
Class II
|
Ongoing |
Z-1886-2026 |
Medline Convenience Kits containing select SKUs of 10mL Polycarbonate Colored Syringes EYE PACK DYNJ35056A HEART … |
— |
Unapproved design changes to the products outside of the 510(k) clearance. |
| 2026-02-27 |
Class II
|
Ongoing |
Z-1885-2026 |
Medline Convenience Kits containing select SKUs of 10mL Polycarbonate Colored Syringes GU DAVINCI PACK - LF DYNJ90939… |
— |
Unapproved design changes to the products outside of the 510(k) clearance. |
| 2026-02-27 |
Class II
|
Ongoing |
Z-1884-2026 |
Medline Convenience Kits containing select SKUs of 10mL Polycarbonate Colored Syringes ANGIO KIT PACK DYNJ50783B … |
— |
Unapproved design changes to the products outside of the 510(k) clearance. |
| 2026-02-27 |
Class II
|
Ongoing |
Z-1883-2026 |
Medline Convenience Kits containing select SKUs of 10mL Polycarbonate Colored Syringes Medline Convenience Kits conta… |
— |
Unapproved design changes to the products outside of the 510(k) clearance. |
| 2026-02-27 |
Class II
|
Ongoing |
Z-1882-2026 |
Medline Convenience Kits containing select SKUs of 10mL Polycarbonate Colored Syringes FACE/RHINOPLASTY PACK DYNJ8034… |
— |
Unapproved design changes to the products outside of the 510(k) clearance. |
| 2026-02-27 |
Class II
|
Ongoing |
Z-1881-2026 |
Medline Convenience Kits containing select SKUs of 10mL Polycarbonate Colored Syringes BARIATRIC DYNJ905153M, DYNJ9… |
— |
Unapproved design changes to the products outside of the 510(k) clearance. |
| 2026-02-27 |
Class II
|
Ongoing |
Z-1880-2026 |
Medline Convenience Kits containing select SKUs of 10mL Polycarbonate Colored Syringes MINOR ENT SINUS PACK-LF … |
— |
Unapproved design changes to the products outside of the 510(k) clearance. |
| 2026-02-27 |
Class II
|
Ongoing |
Z-1879-2026 |
Medline Convenience Kits containing select SKUs of 10mL Polycarbonate Colored Syringes BIOPSY PACK DYNJ38587A, DYNJ38… |
— |
Unapproved design changes to the products outside of the 510(k) clearance. |
| 2026-02-27 |
Class II
|
Ongoing |
Z-1878-2026 |
Medline Convenience Kits containing select SKUs of 10mL Polycarbonate Colored Syringes TAVR PACK DYNJ69246B ABDOMI… |
— |
Unapproved design changes to the products outside of the 510(k) clearance. |
| 2026-02-27 |
Class II
|
Ongoing |
Z-1877-2026 |
Medline Convenience Kits containing select SKUs of 10mL Polycarbonate Colored Syringes ADULT CATH PACK-LF DYNJ38395G… |
— |
Unapproved design changes to the products outside of the 510(k) clearance. |
| 2026-02-27 |
Class II
|
Ongoing |
Z-1876-2026 |
Medline Convenience Kits containing select SKUs of 10mL Polycarbonate Colored Syringes JUDKINS PACK DYNJ51126 AN… |
— |
Unapproved design changes to the products outside of the 510(k) clearance. |
| 2026-02-27 |
Class I
|
Ongoing |
Z-1730-2026 |
Medline medical convenience kits, containing NAMIC Angiographic Rotating Adaptor (RA) Control Syringes (Namic RA syringe… |
— |
Medline Industries, LP has identified through post-market surveillance a potential risk of the syringe rotating adaptor unwinding during use, which may result i… |
| 2026-02-27 |
Class I
|
Ongoing |
Z-1729-2026 |
Medline medical convenience kits, containing NAMIC Angiographic Rotating Adaptor (RA) Control Syringes (Namic RA syringe… |
— |
Medline Industries, LP has identified through post-market surveillance a potential risk of the syringe rotating adaptor unwinding during use, which may result i… |
| 2026-02-27 |
Class I
|
Ongoing |
Z-1728-2026 |
Medline medical convenience kits, containing NAMIC Angiographic Rotating Adaptor (RA) Control Syringes (Namic RA syringe… |
— |
Medline Industries, LP has identified through post-market surveillance a potential risk of the syringe rotating adaptor unwinding during use, which may result i… |
| 2026-02-27 |
Class I
|
Ongoing |
Z-1727-2026 |
Medline medical convenience kits, containing NAMIC Angiographic Rotating Adaptor (RA) Control Syringes (Namic RA syringe… |
— |
Medline Industries, LP has identified through post-market surveillance a potential risk of the syringe rotating adaptor unwinding during use, which may result i… |
| 2026-02-27 |
Class I
|
Ongoing |
Z-1726-2026 |
Medline medical convenience kits, containing NAMIC Angiographic Rotating Adaptor (RA) Control Syringes (Namic RA syringe… |
— |
Medline Industries, LP has identified through post-market surveillance a potential risk of the syringe rotating adaptor unwinding during use, which may result i… |
| 2026-02-27 |
Class I
|
Ongoing |
Z-1725-2026 |
Medline medical convenience kits, containing NAMIC Angiographic Rotating Adaptor (RA) Control Syringes (Namic RA syringe… |
— |
Medline Industries, LP has identified through post-market surveillance a potential risk of the syringe rotating adaptor unwinding during use, which may result i… |
| 2026-02-27 |
Class I
|
Ongoing |
Z-1724-2026 |
Medline medical convenience kits, containing NAMIC Angiographic Rotating Adaptor (RA) Control Syringes (Namic RA syringe… |
— |
Medline Industries, LP has identified through post-market surveillance a potential risk of the syringe rotating adaptor unwinding during use, which may result i… |
| 2026-02-27 |
Class I
|
Ongoing |
Z-1723-2026 |
Medline medical convenience kits, containing NAMIC Angiographic Rotating Adaptor (RA) Control Syringes (Namic RA syringe… |
— |
Medline Industries, LP has identified through post-market surveillance a potential risk of the syringe rotating adaptor unwinding during use, which may result i… |
| 2026-02-27 |
Class I
|
Ongoing |
Z-1722-2026 |
Medline medical convenience kits, containing NAMIC Angiographic Rotating Adaptor (RA) Control Syringes (Namic RA syringe… |
— |
Medline Industries, LP has identified through post-market surveillance a potential risk of the syringe rotating adaptor unwinding during use, which may result i… |
| 2026-02-27 |
Class I
|
Ongoing |
Z-1721-2026 |
Medline medical convenience kits, containing NAMIC Angiographic Rotating Adaptor (RA) Control Syringes (Namic RA syringe… |
— |
Medline Industries, LP has identified through post-market surveillance a potential risk of the syringe rotating adaptor unwinding during use, which may result i… |
| 2026-02-27 |
Class I
|
Ongoing |
Z-1720-2026 |
Medline medical convenience kits, containing NAMIC Angiographic Rotating Adaptor (RA) Control Syringes (Namic RA syringe… |
— |
Medline Industries, LP has identified through post-market surveillance a potential risk of the syringe rotating adaptor unwinding during use, which may result i… |
| 2026-02-27 |
Class I
|
Ongoing |
Z-1719-2026 |
Medline medical convenience kits, containing NAMIC Angiographic Rotating Adaptor (RA) Control Syringes (Namic RA syringe… |
— |
Medline Industries, LP has identified through post-market surveillance a potential risk of the syringe rotating adaptor unwinding during use, which may result i… |
| 2026-02-27 |
Class I
|
Ongoing |
Z-1718-2026 |
NAMIC Angiographic Syringe, labeled as follows: 1. SYRINGE,20ML,CONTROL,-,PKG, Medline SKU 70075027; 2. SYRINGE,10ML,TR/… |
— |
Medline Industries, LP has identified through post-market surveillance a potential risk of the syringe rotating adaptor unwinding during use, which may result i… |
| 2026-02-27 |
Class I
|
Ongoing |
Z-1717-2026 |
NAMIC Angiographic Syringe, labeled as follows: 1. SYRINGE,20ML,CONTROL,-,PKG, Medline SKU 70075027; 2. SYRINGE,10ML,TR/… |
— |
Medline Industries, LP has identified through post-market surveillance a potential risk of the syringe rotating adaptor unwinding during use, which may result i… |
| 2026-02-27 |
Class I
|
Ongoing |
Z-1716-2026 |
Medline medical convenience kits, containing NAMIC Angiographic Rotating Adaptor (RA) Control Syringes (Namic RA syringe… |
— |
Medline Industries, LP has identified through post-market surveillance a potential risk of the syringe rotating adaptor unwinding during use, which may result i… |
| 2026-02-27 |
Class I
|
Ongoing |
Z-1715-2026 |
Medline medical convenience kits, containing NAMIC Angiographic Rotating Adaptor (RA) Control Syringes (Namic RA syringe… |
— |
Medline Industries, LP has identified through post-market surveillance a potential risk of the syringe rotating adaptor unwinding during use, which may result i… |
| 2026-02-27 |
Class I
|
Ongoing |
Z-1714-2026 |
Medline medical convenience kits, containing NAMIC Angiographic Rotating Adaptor (RA) Control Syringes (Namic RA syringe… |
— |
Medline Industries, LP has identified through post-market surveillance a potential risk of the syringe rotating adaptor unwinding during use, which may result i… |
| 2026-02-27 |
Class I
|
Ongoing |
Z-1713-2026 |
NAMIC Angiographic Control Syringe, labeled as follows: 1. SYRINGE,7ML,TR/FR,RA,W/RES,-,P/G, Medline SKU 70083007; … |
— |
Medline Industries, LP has identified through post-market surveillance a potential risk of the syringe rotating adaptor unwinding during use, which may result i… |
| 2026-02-27 |
Class I
|
Ongoing |
Z-1712-2026 |
NAMIC Angiographic Syringe, labeled as follows: 1. SYRINGE,20ML,CONTROL,-,PKG, Medline SKU 70075027; 2. SYRINGE,10M… |
— |
Medline Industries, LP has identified through post-market surveillance a potential risk of the syringe rotating adaptor unwinding during use, which may result i… |
| 2026-02-25 |
Class II
|
Ongoing |
Z-1850-2026 |
Medline Kits: 1) ARTHROSCOPY PACK, Model Number: DYNJ82440 |
— |
The 510(k) regulatory clearances for certain Control Syringes, Guidewires, and/or High-Pressure Tubing have been rescinded. |
| 2026-02-25 |
Class II
|
Ongoing |
Z-1849-2026 |
Medline Kits: 1) BWNBORO CRANIOTOMY PACK-LF, Model Number: DYNJ32841F; 2) CRANIOTOMY PACK-LF, Model Number: DYNJ46069… |
— |
The 510(k) regulatory clearances for certain Control Syringes, Guidewires, and/or High-Pressure Tubing have been rescinded. |
| 2026-02-25 |
Class II
|
Ongoing |
Z-1848-2026 |
Medline Kits: 1) D AND C PACK, Model Number: DYNJ41254B |
— |
The 510(k) regulatory clearances for certain Control Syringes, Guidewires, and/or High-Pressure Tubing have been rescinded. |
| 2026-02-25 |
Class II
|
Ongoing |
Z-1847-2026 |
Medline Kits: 1) HYSTEROSCOPY PACK, Model Number: DYNJ48399C; 2) SLING PACK, Model Number: DYNJ62849B |
— |
The 510(k) regulatory clearances for certain Control Syringes, Guidewires, and/or High-Pressure Tubing have been rescinded. |
| 2026-02-25 |
Class II
|
Ongoing |
Z-1846-2026 |
Medline Kits: 1) GYN LAPAROSCOPY PACK, Model Number: DYNJ41257F |
— |
The 510(k) regulatory clearances for certain Control Syringes, Guidewires, and/or High-Pressure Tubing have been rescinded. |
| 2026-02-25 |
Class II
|
Ongoing |
Z-1845-2026 |
Medline Kits: 1) LABOR PACK-22025208-LF, Model Number: DYNJ44813D |
— |
The 510(k) regulatory clearances for certain Control Syringes, Guidewires, and/or High-Pressure Tubing have been rescinded. |
| 2026-02-25 |
Class II
|
Ongoing |
Z-1844-2026 |
Medline Kits: 1) ARTHROGRAM TRAY, Model Number: DYNJ07425; 2) TOL NEURO ANGIO PACK, Model Number: DYNJ38610I 3) ANGI… |
— |
The 510(k) regulatory clearances for certain Control Syringes, Guidewires, and/or High-Pressure Tubing have been rescinded. |
| 2026-02-25 |
Class II
|
Ongoing |
Z-1843-2026 |
Medline Kits: 1) SYR CONTROL 8ML ROTATING, Model Number: DNSC89369; 2) SYRINGE 10ML CONTROL MLL, Model Number: DYNJSY… |
— |
The 510(k) regulatory clearances for certain Control Syringes, Guidewires, and/or High-Pressure Tubing have been rescinded. |
| 2026-02-25 |
Class II
|
Ongoing |
Z-1842-2026 |
Medline Kits: 1) NEWBORN ADMISSION, Model Number: DYKB1038; 2) DRAINAGE TRAY, Model Number: DYNDA3188; 3) VA ORLAND… |
— |
The 510(k) regulatory clearances for certain Control Syringes, Guidewires, and/or High-Pressure Tubing have been rescinded. |
| 2026-02-25 |
Class II
|
Ongoing |
Z-1841-2026 |
Medline Kits: 1) BREAST PACK, Model Number: DYNJ66777D |
— |
The 510(k) regulatory clearances for certain Control Syringes, Guidewires, and/or High-Pressure Tubing have been rescinded. |
| 2026-02-25 |
Class II
|
Ongoing |
Z-1840-2026 |
Medline Kits: 1) GENERAL LAPAROSCOPY, Model Number: CDS930027Y |
— |
The 510(k) regulatory clearances for certain Control Syringes, Guidewires, and/or High-Pressure Tubing have been rescinded. |
| 2026-02-25 |
Class II
|
Ongoing |
Z-1839-2026 |
Medline Kits: 1) ENT PACK, Model Number: DYNJ59030B; 2) ENT, Model Number: DYNJ908586C; 3) LH 3 PORT W/O WASTEBAG, … |
— |
The 510(k) regulatory clearances for certain Control Syringes, Guidewires, and/or High-Pressure Tubing have been rescinded. |
| 2026-02-25 |
Class II
|
Ongoing |
Z-1838-2026 |
Medline Kits: 1) HEART TRANSPLANT BIOPSY, Model Number: DYNJ37543A |
— |
The 510(k) regulatory clearances for certain Control Syringes, Guidewires, and/or High-Pressure Tubing have been rescinded. |
| 2026-02-25 |
Class II
|
Ongoing |
Z-1837-2026 |
Medline Kits: 1) PICC TRAY, Model Number: DYNJ41648A |
— |
The 510(k) regulatory clearances for certain Control Syringes, Guidewires, and/or High-Pressure Tubing have been rescinded. |
| 2026-02-25 |
Class II
|
Ongoing |
Z-1836-2026 |
Medline Kits: 1) MTS LEFT HEART KIT-CAROLINAS HOS, Model Number: 60021775; 2) DBD-MTS LHK BHS BAPTIST. LOUISVI, Model… |
— |
The 510(k) regulatory clearances for certain Control Syringes, Guidewires, and/or High-Pressure Tubing have been rescinded. |
| 2026-02-25 |
Class II
|
Ongoing |
Z-1835-2026 |
Medline Kits: 1) CATH LAB CDS, Model Number: CDS840228F; 2) IR PACK, Model Number: DYNDH2104; 3) CARDIAC CATH PACK-LF,… |
— |
The 510(k) regulatory clearances for certain Control Syringes, Guidewires, and/or High-Pressure Tubing have been rescinded. |
| 2026-02-25 |
Class II
|
Ongoing |
Z-1834-2026 |
Medline Kits: 1) ANGIOGRAPHY PACK-LF, Model Number: DYNJQ0505M; 2) ANGIO PACK, Model Number: DYNJT2021G; 3) ANGIOGR… |
— |
The 510(k) regulatory clearances for certain Control Syringes, Guidewires, and/or High-Pressure Tubing have been rescinded. |
| 2026-02-25 |
Class II
|
Ongoing |
Z-1833-2026 |
Medline Kits: 1) SYR CNTRL 10ML RING W/ROT NB, Model Number: DYNJSYR10CWRB; 2) MANIFOLD KIT LOW PRESSURE OFF, Model N… |
— |
The 510(k) regulatory clearances for certain Control Syringes, Guidewires, and/or High-Pressure Tubing have been rescinded. |
| 2026-02-25 |
Class II
|
Ongoing |
Z-1832-2026 |
Medline Kits: 1) ANGIO CATH PACK-MARY IMMACULAT, Model Number: DYNJ24517D |
— |
The 510(k) regulatory clearances for certain Control Syringes, Guidewires, and/or High-Pressure Tubing have been rescinded. |
| 2026-02-25 |
Class II
|
Ongoing |
Z-1831-2026 |
Medline Syringes: 1) SYRINGE 12ML CONTROL W/ROTATOR, Model Number: DYNJSYR12CWR; 2) SYRINGE 10ML CONTROL W/ROTATOR, M… |
— |
The 510(k) regulatory clearances for certain Control Syringes, Guidewires, and/or High-Pressure Tubing have been rescinded. |
| 2026-02-25 |
Class II
|
Ongoing |
Z-1830-2026 |
Medline Namic Syringes: 1) SYR CNTRL 10ML RING W/ROT NB, Model Number: DYNJSYR10CWRB; |
— |
The 510(k) regulatory clearances for certain Control Syringes, Guidewires, and/or High-Pressure Tubing have been rescinded. |
| 2026-02-25 |
Class II
|
Ongoing |
Z-1829-2026 |
Medline Namic Guidewires: 1) GUIDEWIRE 3MMJ 0.035X260CM LT, Model Number: DYNJGWIRE20L; 2) GWIRE HYDRO 0.035 180CM AN… |
— |
The 510(k) regulatory clearances for certain Control Syringes, Guidewires, and/or High-Pressure Tubing have been rescinded. |
| 2026-02-18 |
Class II
|
Ongoing |
Z-1693-2026 |
Sterile Radiology Procedure Kits, Model Number DYNDH1491B |
— |
There is a potential breach in the sterile pouch packaging for one lot of radiology kits, which may compromise product sterility. |
| 2026-02-16 |
Class II
|
Ongoing |
Z-1711-2026 |
MEDLINE ANTERIOR HIP PACK DYNJ64672B |
— |
Kits contain recalled Olympus biopsy valves. Olympus is investigating an increase in complaints associated with rubber fragment detachment in the slit of single… |
| 2026-02-16 |
Class II
|
Ongoing |
Z-1710-2026 |
Medline kits containing Olympus biopsy valves: 1. BRONCH PROCEDURE KIT, DYKE2091 2. BRONCHSCOPY, DYNJ900898G DYNJ9… |
— |
Kits contain recalled Olympus biopsy valves. Olympus is investigating an increase in complaints associated with rubber fragment detachment in the slit of single… |
| 2026-02-16 |
Class II
|
Ongoing |
Z-1709-2026 |
Medline kits containing Olympus biopsy valves: 1. BRONCHOSCOPY, DYNJ900898I DYNJ901922G 2. FLEXIBLE BRONCHOSCOPY K… |
— |
Kits contain recalled Olympus biopsy valves. Olympus is investigating an increase in complaints associated with rubber fragment detachment in the slit of single… |
| 2026-02-16 |
Class II
|
Ongoing |
Z-1708-2026 |
Medline kits containing Olympus biopsy valves: 1. BAL KIT, DYNDA2137B 2. ENDO KIT, DYKE1915 |
— |
Kits contain recalled Olympus biopsy valves. Olympus is investigating an increase in complaints associated with rubber fragment detachment in the slit of single… |
| 2026-02-16 |
Class II
|
Ongoing |
Z-1707-2026 |
THORACIC ROBOTS, DYNJ908777B |
— |
Kits contain recalled Olympus biopsy valves. Olympus is investigating an increase in complaints associated with rubber fragment detachment in the slit of single… |
| 2026-02-16 |
Class II
|
Ongoing |
Z-1707-2026 |
THORACIC ROBOTS, DYNJ908777B |
— |
Kits contain recalled Olympus biopsy valves. Olympus is investigating an increase in complaints associated with rubber fragment detachment in the slit of single… |
| 2026-02-16 |
Class II
|
Ongoing |
Z-1706-2026 |
Medline convenience kits containing Olympus biopsy valves: 1. BRONCH PACK, DYKE2096 2. NON MB BRONCHOPSCOPY CCH LH P… |
— |
Kits contain recalled Olympus biopsy valves. Olympus is investigating an increase in complaints associated with rubber fragment detachment in the slit of single… |
| 2026-02-16 |
Class II
|
Ongoing |
Z-1705-2026 |
Airway Exam Kit, DYKE1796 |
— |
Kits contain recalled Olympus biopsy valves. Olympus is investigating an increase in complaints associated with rubber fragment detachment in the slit of single… |
| 2026-02-13 |
Class II
|
Ongoing |
Z-1691-2026 |
Medline Kits containing ENFIT G-TUBE CONNECTOR 1. SKU DYKM2720 G/J TUBE CARE KIT 2. SKU ENFITDISCKIT ENFIT DISCH… |
— |
Connectors were not manufactured to required dimensional specifications and may not form a proper seal with ENFit-style devices, which could lead to leakage. Le… |
| 2026-02-13 |
Class II
|
Ongoing |
Z-1690-2026 |
ENFIT G-TUBE CONNECTOR, MEDLINE Item No. ENFIT1010GC |
— |
Connectors were not manufactured to required dimensional specifications and may not form a proper seal with ENFit-style devices, which could lead to leakage. Le… |
| 2026-02-10 |
Class II
|
Ongoing |
Z-1650-2026 |
Puracol and Puracol Plus Collagen Wound Dressings: MSC8522 DRESSING,COLLAGEN,PURACOL,STRL,2" X 2" MSC8622EP DRESSING… |
— |
Elevated endotoxin levels identified in affected lots. Issue may elicit strong inflammatory response if used, including local tissue irritation, delayed wound h… |
| 2026-01-30 |
Class II
|
Ongoing |
Z-1562-2026 |
Medline Kits containing Cardinal Health s Aqua-Seal Chest Drainage Unit: 1) OPEN HEART, Model Number: DYNJ902487A; 2)… |
— |
The instructions for use (IFUs) on specified Cardinal Health Chest Drainage Units (CDUs) and accessories have been updated to clarify the intended target patien… |
| 2026-01-28 |
Class II
|
Ongoing |
Z-1564-2026 |
Medline Surgical Drapes: MDTBTCS6070GN DBD-DRAPE,COVER,TABLE,RESIS/XALT GRN,60X MDTBTCS6090GN DBD-DRAPE,COVER,TABLE,RES… |
— |
Fabric may experience premature delamination when using included laundering instructions. Identifying delaminated gown or drape in a surgical setting may result… |
| 2026-01-28 |
Class II
|
Ongoing |
Z-1563-2026 |
Medline Medcrest Surgical Gowns: MDTGXC4J5XL DBQ-GOWN,SURG,XALT,L4, CRTCL CVR, GRN, 5 MDTGXC4JL DBD-GOWN,SURG,XALT,L… |
— |
Fabric may experience premature delamination when using included laundering instructions. Identifying delaminated gown or drape in a surgical setting may result… |
| 2026-01-08 |
Class II
|
Ongoing |
Z-1468-2026 |
Convenience kits containing Tego Connectors Medline DIALYSIS DRSNG CHNG SKU DYNDC3167 |
— |
Affected lots may exhibit issues with the silicone seal on Tego Connectors included in kits. Issues include silicone seal doming and silicone seal tearing. Thes… |
| 2026-01-08 |
Class II
|
Ongoing |
Z-1467-2026 |
Convenience kits containing Tego Connectors: Medline DIALYSIS DRESSING CHANGE SKU EBSI1498 Medline DIALYSIS DRESS… |
— |
Affected lots may exhibit issues with the silicone seal on Tego Connectors included in kits. Issues include silicone seal doming and silicone seal tearing. Thes… |
| 2026-01-08 |
Class II
|
Ongoing |
Z-1466-2026 |
Medline kits containing Tego Connectors Medline APHERESIS SUBQPORT ACCESS KIT SKU DYNDA2705 Medline CENTRAL LINE … |
— |
Affected lots may exhibit issues with the silicone seal on Tego Connectors included in kits. Issues include silicone seal doming and silicone seal tearing. Thes… |
| 2026-01-08 |
Class II
|
Ongoing |
Z-1465-2026 |
Convenience kits used for dialysis maintenance Medline ADD A CATH DIALYSIS KIT SKU ECVC8415A Centurion CENTRAL LI… |
— |
Affected lots may exhibit issues with the silicone seal on Tego Connectors included in kits. Issues include silicone seal doming and silicone seal tearing. Thes… |
| 2026-01-08 |
Class II
|
Ongoing |
Z-1464-2026 |
Medline Kits containing Tego Connectors Medline DIALYSIS ON/OFF KIT SKU EBSI1746 |
— |
Affected lots may exhibit issues with the silicone seal on Tego Connectors included in kits. Issues include silicone seal doming and silicone seal tearing. Thes… |
| 2026-01-08 |
Class II
|
Ongoing |
Z-1463-2026 |
Medline Kits containing Tego Connectors: Medline IR Pack, SKU DYNJ67205C Medline NO CATHETER DIALYSIS INSERTION, SKU C… |
— |
Affected lots may exhibit issues with the silicone seal on Tego Connectors included in kits. Issues include silicone seal doming and silicone seal tearing. Thes… |
| 2026-01-07 |
Class II
|
Ongoing |
Z-2130-2026 |
Medline Surgical Packs: 1) PACK,UNIVERSAL,ULTRAGARD,5/CS, Model Number: DYNJP1050UG; 2) PACK,SHOULDER,DRAPE,POUCH,10/… |
— |
Medline has identified issues related to calibration of the equipment used to sterilize and package the devices. All products were exposed to the validated ster… |
| 2026-01-07 |
Class II
|
Ongoing |
Z-2129-2026 |
See complete list in RES, exceeds character limit. Medline Surgical Gowns |
— |
Medline has identified issues related to calibration of the equipment used to sterilize and package the devices. All products were exposed to the validated ster… |
| 2026-01-07 |
Class II
|
Ongoing |
Z-2128-2026 |
Medline Surgical Drapes: 1) SHEET,DRAPE,40X58,STERILE, Model Number: DYNJP2410; 2) DRAPE,SHEET,ECONOMY,40X58",ST,20/C… |
— |
Medline has identified issues related to calibration of the equipment used to sterilize and package the devices. All products were exposed to the validated ster… |
| 2026-01-07 |
Class II
|
Ongoing |
Z-2127-2026 |
Medline Convenience Kits: 1) ARTHROSCOPY CDS, Model Number: CDS984609B; 2) ARTHROSCOPY TRAYS, Model Number: DYNJ22501… |
— |
Medline has identified issues related to calibration of the equipment used to sterilize and package the devices. All products were exposed to the validated ster… |
| 2026-01-07 |
Class II
|
Ongoing |
Z-2126-2026 |
Medline Convenience Kits: 1) KIT UROLOGY SLING, Model Number: DYKMBNDL106; 2) KIT UROLOGY SLING, Model Number: DYKMBN… |
— |
Medline has identified issues related to calibration of the equipment used to sterilize and package the devices. All products were exposed to the validated ster… |
| 2026-01-07 |
Class II
|
Ongoing |
Z-2125-2026 |
Medline Convenience Kits: 1) LVAD DRIVELINE TRAY, Model Number: DM1035; 2) LVAD DRIVELINE TRAY, Model Number: DM1035A… |
— |
Medline has identified issues related to calibration of the equipment used to sterilize and package the devices. All products were exposed to the validated ster… |
| 2026-01-07 |
Class II
|
Ongoing |
Z-2124-2026 |
Medline Convenience Kits: 1) DRAPE PACK, Model Number: DYNJ35363A; 2) SICK KIDS-GENERAL CUSTOM SPLIT, Model Number: S… |
— |
Medline has identified issues related to calibration of the equipment used to sterilize and package the devices. All products were exposed to the validated ster… |
| 2026-01-07 |
Class II
|
Ongoing |
Z-2123-2026 |
Medline Convenience Kits: 1) KIT TRIPLE LUMEN INSERTION, Model Number: DYNDM1031A |
— |
Medline has identified issues related to calibration of the equipment used to sterilize and package the devices. All products were exposed to the validated ster… |
| 2026-01-07 |
Class II
|
Ongoing |
Z-2122-2026 |
Medline Convenience Kits: 1) DRAPE PACK-CHOICE, Model Number: DYNJ63118A |
— |
Medline has identified issues related to calibration of the equipment used to sterilize and package the devices. All products were exposed to the validated ster… |
| 2026-01-07 |
Class II
|
Ongoing |
Z-2121-2026 |
Medline Convenience Kits: 1) KIT GENERAL CLOSURE, Model Number: DYKMBNDL200A |
— |
Medline has identified issues related to calibration of the equipment used to sterilize and package the devices. All products were exposed to the validated ster… |
| 2026-01-07 |
Class II
|
Ongoing |
Z-2120-2026 |
Medline Convenience Kits: 1) BURN PACK, Model Number: DYNJ15668R; 2) BURN PACK-LF, Model Number: DYNJ42829B; 3) BUR… |
— |
Medline has identified issues related to calibration of the equipment used to sterilize and package the devices. All products were exposed to the validated ster… |
| 2026-01-07 |
Class II
|
Ongoing |
Z-2119-2026 |
Medline Convenience Kits: 1) WMC I D PACK-LF, Model Number: DYNJ50806L |
— |
Medline has identified issues related to calibration of the equipment used to sterilize and package the devices. All products were exposed to the validated ster… |
| 2026-01-07 |
Class II
|
Ongoing |
Z-2118-2026 |
Medline Convenience Kits: 1) PICC CATHETER INSERTION TRAY, Model Number: CVI4300; 2) OSC SHERMAN KNEE ARTHRO BASIC, M… |
— |
Medline has identified issues related to calibration of the equipment used to sterilize and package the devices. All products were exposed to the validated ster… |
| 2026-01-07 |
Class II
|
Ongoing |
Z-2117-2026 |
Medline Convenience Kits: 1) BAPTIST FLOYD ENDO GI KIT, Model Number: DYKE1455B; 2) GI LAB OTHER ENDO KIT, Model Numb… |
— |
Medline has identified issues related to calibration of the equipment used to sterilize and package the devices. All products were exposed to the validated ster… |
| 2026-01-07 |
Class II
|
Ongoing |
Z-2116-2026 |
Medline Convenience Kits: 1) BASIC NERVE BLOCK TRAY W/LINEN, Model Number:PAIN0150C |
— |
Medline has identified issues related to calibration of the equipment used to sterilize and package the devices. All products were exposed to the validated ster… |
| 2026-01-07 |
Class II
|
Ongoing |
Z-2115-2026 |
Medline Convenience Kits: 1) KIT STC TRACHEOSTOMY, Model Number:DYKMBNDL55; 2) KIT STC TRACHEOSTOMY, Model Number:DYK… |
— |
Medline has identified issues related to calibration of the equipment used to sterilize and package the devices. All products were exposed to the validated ster… |
| 2026-01-07 |
Class II
|
Ongoing |
Z-2114-2026 |
See RES for complete list. Medline Convenience Kits: 1) SPINAL CDS, Model Number: CDS940087AG; 2) SPINAL CDS, Model Numb… |
— |
Medline has identified issues related to calibration of the equipment used to sterilize and package the devices. All products were exposed to the validated ster… |
| 2026-01-07 |
Class II
|
Ongoing |
Z-2113-2026 |
Medline Convenience Kits: 1) KIT OPHTHALMIC RUPTURE GLOBE, Model Number: DYKMBNDL104; 2) KIT OPHTHALMIC RUPTURE GLOBE… |
— |
Medline has identified issues related to calibration of the equipment used to sterilize and package the devices. All products were exposed to the validated ster… |
| 2026-01-07 |
Class II
|
Ongoing |
Z-2112-2026 |
Medline Convenience Kits: 1) BAP NORTH ROBOTIC SURGERY CDS, Model Number: CDS982407N; 2) BAP NORTH ROBOTIC SURGERY CD… |
— |
Medline has identified issues related to calibration of the equipment used to sterilize and package the devices. All products were exposed to the validated ster… |
| 2026-01-07 |
Class II
|
Ongoing |
Z-2111-2026 |
Medline Convenience Kits: 1) HYSTEROSCOPY, Model Number: CDS984086I; 2) KIT GYN ONCOLOGY LAP, Model Number: DYKMBNDL9… |
— |
Medline has identified issues related to calibration of the equipment used to sterilize and package the devices. All products were exposed to the validated ster… |
| 2026-01-07 |
Class II
|
Ongoing |
Z-2110-2026 |
Medline Convenience Kits: 1) C-SECTION PACK, Model Number: CDS820080N; 2) C-SECTION CDS, Model Number: CDS983523G; … |
— |
Medline has identified issues related to calibration of the equipment used to sterilize and package the devices. All products were exposed to the validated ster… |
| 2026-01-07 |
Class II
|
Ongoing |
Z-2109-2026 |
See full list in RES, exceeds character limit 1) GYN LAPAROSCOPY CDS, Model Number: CDS981504G; 2) BAP NORTH ROBOTIC … |
— |
Medline has identified issues related to calibration of the equipment used to sterilize and package the devices. All products were exposed to the validated ster… |
| 2026-01-07 |
Class II
|
Ongoing |
Z-2108-2026 |
Medline Convenience Kits: 1) OB KIT, Model Number: DYKM2326; 2) KIT LABOR DELIVERY TUBAL LIGAT, Model Number: DYKMBND… |
— |
Medline has identified issues related to calibration of the equipment used to sterilize and package the devices. All products were exposed to the validated ster… |
| 2026-01-07 |
Class II
|
Ongoing |
Z-2107-2026 |
Medline Convenience Kits: 1) NEURO SHUNT- CODMAN, Model Number: CDS860018G; 2) NEURO SHUNT- CODMAN, Model Number: CDS… |
— |
Medline has identified issues related to calibration of the equipment used to sterilize and package the devices. All products were exposed to the validated ster… |
| 2026-01-07 |
Class II
|
Ongoing |
Z-2106-2026 |
Medline Convenience Kits: 1) CHEST TUBE INSERTION TRAY, Model Number: DYNDA2941A; 2) CHEST/BREAST-LF, Model Number: D… |
— |
Medline has identified issues related to calibration of the equipment used to sterilize and package the devices. All products were exposed to the validated ster… |
| 2026-01-07 |
Class II
|
Ongoing |
Z-2105-2026 |
Medline Convenience Kits: 1) ADMIT KIT, Model Number: DYKA1343A |
— |
Medline has identified issues related to calibration of the equipment used to sterilize and package the devices. All products were exposed to the validated ster… |
| 2026-01-07 |
Class II
|
Ongoing |
Z-2104-2026 |
Medline Convenience Kits: 1) PPE KIT, Model Number: DYK1011945P |
— |
Medline has identified issues related to calibration of the equipment used to sterilize and package the devices. All products were exposed to the validated ster… |
| 2026-01-07 |
Class II
|
Ongoing |
Z-2103-2026 |
Medline Convenience Kits: 1) CENTRAL LINE UNIVERSAL INSERTI, Model Number: CVI3780; 2) LVAD DRIVELINE TRAY, Model Num… |
— |
Medline has identified issues related to calibration of the equipment used to sterilize and package the devices. All products were exposed to the validated ster… |
| 2026-01-07 |
Class II
|
Ongoing |
Z-2102-2026 |
Medline Convenience Kits: 1) CVC PACK, Model Number: CVI4500A; 2) TOTE KAMAL OSC HAND REPAIR, Model Number: DYKM1730A… |
— |
Medline has identified issues related to calibration of the equipment used to sterilize and package the devices. All products were exposed to the validated ster… |
| 2026-01-07 |
Class II
|
Ongoing |
Z-2101-2026 |
See RES for complete list. Medline Convenience Kits: 1) DRAWER 6-IV FLUIDS GLOVES, Model Number: ACC010326; 2) DRAWER 6-… |
— |
Medline has identified issues related to calibration of the equipment used to sterilize and package the devices. All products were exposed to the validated ster… |
| 2026-01-07 |
Class II
|
Ongoing |
Z-2100-2026 |
Medline Convenience Kits: 1) LITHOTOMY PACK, Model Number: DYNJ83185; 2) LITHOTOMY PACK, Model Number: DYNJ83185A; … |
— |
Medline has identified issues related to calibration of the equipment used to sterilize and package the devices. All products were exposed to the validated ster… |
| 2026-01-07 |
Class II
|
Ongoing |
Z-2099-2026 |
See RES for complete list. Medline Convenience Kits: 1) PLASTIC BIN W/MISC KITS, Model Number: ACC010499; 2) BREAST-HERN… |
— |
Medline has identified issues related to calibration of the equipment used to sterilize and package the devices. All products were exposed to the validated ster… |
| 2026-01-07 |
Class II
|
Ongoing |
Z-2098-2026 |
See RES for complete list. Medline Convenience Kits: 1) MAJOR LAPAROTOMY CDS, Model Number: CDS860015U; 2) MAJOR LAPAROT… |
— |
Medline has identified issues related to calibration of the equipment used to sterilize and package the devices. All products were exposed to the validated ster… |
| 2026-01-07 |
Class II
|
Ongoing |
Z-2097-2026 |
See RES for full list. Medline Convenience Kits: 1) CHP COCHLEAR SUPPLEMENT CDS, Model Number: CDS983069G; 2) CHP COCHL… |
— |
Medline has identified issues related to calibration of the equipment used to sterilize and package the devices. All products were exposed to the validated ster… |
| 2026-01-07 |
Class II
|
Ongoing |
Z-2096-2026 |
Medline Convenience Kits: 1) DYNDA3003, Model Number: DENTAL PACK; 2) DYNJ87157, Model Number: GULLO SURGICAL PACK |
— |
Medline has identified issues related to calibration of the equipment used to sterilize and package the devices. All products were exposed to the validated ster… |
| 2026-01-07 |
Class II
|
Ongoing |
Z-2095-2026 |
Medline Convenience Kits: 1) KIT SURG ONC EXCISION BREAST, Model Number:DYKMBNDL84A; 2) KIT SURG ONC EXPLORATORY LAP,… |
— |
Medline has identified issues related to calibration of the equipment used to sterilize and package the devices. All products were exposed to the validated ster… |
| 2026-01-07 |
Class II
|
Ongoing |
Z-2094-2026 |
Medline Convenience Kits: 1) PICC LINE TRAY, Model Number:00-401993O; 2) CODE CART ADULT 4 CENTRAL LINE, Model Number… |
— |
Medline has identified issues related to calibration of the equipment used to sterilize and package the devices. All products were exposed to the validated ster… |
| 2026-01-07 |
Class II
|
Ongoing |
Z-2093-2026 |
See RES for complete list. Medline Convenience Kits: 1) OPEN HEART CDS, Model Number:CDS840015AQ; 2) OPEN HEART CDS, Mod… |
— |
Medline has identified issues related to calibration of the equipment used to sterilize and package the devices. All products were exposed to the validated ster… |
| 2026-01-07 |
Class II
|
Ongoing |
Z-2092-2026 |
Medline Convenience Kits: 1) ANGIO PROCEDURE PACK, Model Number:00-401824AB; 2) OR ARTERIOGRAM, Model Number:CDS98509… |
— |
Medline has identified issues related to calibration of the equipment used to sterilize and package the devices. All products were exposed to the validated ster… |
| 2026-01-07 |
Class II
|
Ongoing |
Z-2091-2026 |
Medline Convenience Kits: 1) ANGIO PROCEDURE PACK, Model Number:00-401824AA; 2) ENDO KIT W/SYRINGE, Model Number:DYKE… |
— |
Medline has identified issues related to calibration of the equipment used to sterilize and package the devices. All products were exposed to the validated ster… |
| 2026-01-07 |
Class II
|
Ongoing |
Z-2090-2026 |
Medline Convenience Kits: 1) SCC RF PAIN MGMT, Model Number:DYNJ56436A; 2) SCC RF PAIN MGMT, Model Number:DYNJ56436B;… |
— |
Medline has identified issues related to calibration of the equipment used to sterilize and package the devices. All products were exposed to the validated ster… |
| 2026-01-07 |
Class II
|
Ongoing |
Z-2089-2026 |
Medline Convenience Kits: 1) ANCILLARY PACK-LF, Model Number:DYNJ0185290G; 2) OPEN HEART ANESTHESIA ICC-A, Model Numb… |
— |
Medline has identified issues related to calibration of the equipment used to sterilize and package the devices. All products were exposed to the validated ster… |
| 2026-01-07 |
Class II
|
Ongoing |
Z-1425-2026 |
Medline Surgical Packs: 1) PACK,UNIVERSAL,ULTRAGARD,5/CS, Model Number: DYNJP1050UG; 2) PACK,SHOULDER,DRAPE,POUCH,10/… |
— |
Medline has identified issues related to calibration of the equipment used to sterilize and package the devices. All products were exposed to the validated ster… |
| 2026-01-07 |
Class II
|
Ongoing |
Z-1424-2026 |
Medline Surgical Gowns: 1) GOWN,NONRNF,L,30/CS, Model Number: DYNJP2001; 2) GOWN,SIRUS,NONRNF,SETINSLV,L,20/CS, Model… |
— |
Medline has identified issues related to calibration of the equipment used to sterilize and package the devices. All products were exposed to the validated ster… |
| 2026-01-07 |
Class II
|
Ongoing |
Z-1423-2026 |
Medline Surgical Drapes: 1) SHEET,DRAPE,40X58,STERILE, Model Number: DYNJP2410; 2) DRAPE,SHEET,ECONOMY,40X58",ST,20/C… |
— |
Medline has identified issues related to calibration of the equipment used to sterilize and package the devices. All products were exposed to the validated ster… |
| 2026-01-07 |
Class II
|
Ongoing |
Z-1422-2026 |
Medline Convenience Kits: 1) ARTHROSCOPY CDS, Model Number: CDS984609B; 2) ARTHROSCOPY TRAYS, Model Number: DYNJ22501… |
— |
Medline has identified issues related to calibration of the equipment used to sterilize and package the devices. All products were exposed to the validated ster… |
| 2026-01-07 |
Class II
|
Ongoing |
Z-1421-2026 |
Medline Convenience Kits: 1) SPINAL CDS, Model Number: CDS940087AG; 2) SPINAL CDS, Model Number: CDS940087AI; 3) TO… |
— |
Medline has identified issues related to calibration of the equipment used to sterilize and package the devices. All products were exposed to the validated ster… |
| 2026-01-07 |
Class II
|
Ongoing |
Z-1420-2026 |
Medline Convenience Kits: 1) KIT OPHTHALMIC RUPTURE GLOBE, Model Number: DYKMBNDL104; 2) KIT OPHTHALMIC RUPTURE GLOBE… |
— |
Medline has identified issues related to calibration of the equipment used to sterilize and package the devices. All products were exposed to the validated ster… |
| 2026-01-07 |
Class II
|
Ongoing |
Z-1419-2026 |
Medline Convenience Kits: 1) BAP NORTH ROBOTIC SURGERY CDS, Model Number: CDS982407N; 2) TOT/ GYN LITHOTOMY CDS, Mode… |
— |
Medline has identified issues related to calibration of the equipment used to sterilize and package the devices. All products were exposed to the validated ster… |
| 2026-01-07 |
Class II
|
Ongoing |
Z-1418-2026 |
Medline Convenience Kits: 1) HYSTEROSCOPY, Model Number: CDS984086I; 2) KIT GYN ONCOLOGY LAP, Model Number: DYKMBNDL9… |
— |
Medline has identified issues related to calibration of the equipment used to sterilize and package the devices. All products were exposed to the validated ster… |
| 2026-01-07 |
Class II
|
Ongoing |
Z-1417-2026 |
Medline Convenience Kits: 1) C-SECTION PACK, Model Number: CDS820080N; 2) C-SECTION CDS, Model Number: CDS983523G; … |
— |
Medline has identified issues related to calibration of the equipment used to sterilize and package the devices. All products were exposed to the validated ster… |
| 2026-01-07 |
Class II
|
Ongoing |
Z-1416-2026 |
Medline Convenience Kits: 1) KIT UROLOGY SLING, Model Number: DYKMBNDL106; 2) KIT UROLOGY SLING, Model Number: DYKMBN… |
— |
Medline has identified issues related to calibration of the equipment used to sterilize and package the devices. All products were exposed to the validated ster… |
| 2026-01-07 |
Class II
|
Ongoing |
Z-1415-2026 |
Medline Convenience Kits: 1) ROBOTIC GYN CDS-1, Model Number: CDS982893I; 2) GYN LAPAROSCOPY CDS, Model Number: CDS98… |
— |
Medline has identified issues related to calibration of the equipment used to sterilize and package the devices. All products were exposed to the validated ster… |
| 2026-01-07 |
Class II
|
Ongoing |
Z-1414-2026 |
Medline Convenience Kits: 1) OB KIT, Model Number: DYKM2326; 2) KIT LABOR DELIVERY TUBAL LIGAT, Model Number: DYKMBND… |
— |
Medline has identified issues related to calibration of the equipment used to sterilize and package the devices. All products were exposed to the validated ster… |
| 2026-01-07 |
Class II
|
Ongoing |
Z-1413-2026 |
Medline Convenience Kits: 1) NEURO SHUNT- CODMAN, Model Number: CDS860018G; 2) NEURO SHUNT- CODMAN, Model Number: CDS… |
— |
Medline has identified issues related to calibration of the equipment used to sterilize and package the devices. All products were exposed to the validated ster… |
| 2026-01-07 |
Class II
|
Ongoing |
Z-1412-2026 |
Medline Convenience Kits: 1) CHEST/BREAST-LF, Model Number: DYNJ83950 |
— |
Medline has identified issues related to calibration of the equipment used to sterilize and package the devices. All products were exposed to the validated ster… |
| 2026-01-07 |
Class II
|
Ongoing |
Z-1411-2026 |
Medline Convenience Kits: 1) LVAD DRIVELINE TRAY, Model Number: DM1035A; 2) LVAD DRIVELINE TRAY, Model Number: DM1035… |
— |
Medline has identified issues related to calibration of the equipment used to sterilize and package the devices. All products were exposed to the validated ster… |
| 2026-01-07 |
Class II
|
Ongoing |
Z-1410-2026 |
Medline Convenience Kits: 1) ADMIT KIT, Model Number: DYKA1343A |
— |
Medline has identified issues related to calibration of the equipment used to sterilize and package the devices. All products were exposed to the validated ster… |
| 2026-01-07 |
Class II
|
Ongoing |
Z-1409-2026 |
Medline Convenience Kits: 1) DRAPE PACK, Model Number: DYNJ35363A; 2) SICK KIDS-GENERAL CUSTOM SPLIT, Model Number: S… |
— |
Medline has identified issues related to calibration of the equipment used to sterilize and package the devices. All products were exposed to the validated ster… |
| 2026-01-07 |
Class II
|
Ongoing |
Z-1408-2026 |
Medline Convenience Kits: 1) PPE KIT, Model Number: DYK1011945P |
— |
Medline has identified issues related to calibration of the equipment used to sterilize and package the devices. All products were exposed to the validated ster… |
| 2026-01-07 |
Class II
|
Ongoing |
Z-1407-2026 |
Medline Convenience Kits: 1) KIT TRIPLE LUMEN INSERTION, Model Number: DYNDM1031A |
— |
Medline has identified issues related to calibration of the equipment used to sterilize and package the devices. All products were exposed to the validated ster… |
| 2026-01-07 |
Class II
|
Ongoing |
Z-1406-2026 |
Medline Convenience Kits: 1) DRAPE PACK-CHOICE, Model Number: DYNJ63118A |
— |
Medline has identified issues related to calibration of the equipment used to sterilize and package the devices. All products were exposed to the validated ster… |
| 2026-01-07 |
Class II
|
Ongoing |
Z-1405-2026 |
Medline Convenience Kits: 1) KIT GENERAL CLOSURE, Model Number: DYKMBNDL200A |
— |
Medline has identified issues related to calibration of the equipment used to sterilize and package the devices. All products were exposed to the validated ster… |
| 2026-01-07 |
Class II
|
Ongoing |
Z-1404-2026 |
Medline Convenience Kits: 1) BURN PACK, Model Number: DYNJ15668R; 2) BURN PACK-LF, Model Number: DYNJ42829B; 3) BUR… |
— |
Medline has identified issues related to calibration of the equipment used to sterilize and package the devices. All products were exposed to the validated ster… |
| 2026-01-07 |
Class II
|
Ongoing |
Z-1403-2026 |
Medline Convenience Kits: 1) WMC I D PACK-LF, Model Number: DYNJ50806L |
— |
Medline has identified issues related to calibration of the equipment used to sterilize and package the devices. All products were exposed to the validated ster… |
| 2026-01-07 |
Class II
|
Ongoing |
Z-1402-2026 |
Medline Convenience Kits: 1) LVAD DRIVELINE TRAY, Model Number: DM1035; 2) KIT SURG ONC INSERT CENT.VENOU, Model Numb… |
— |
Medline has identified issues related to calibration of the equipment used to sterilize and package the devices. All products were exposed to the validated ster… |
| 2026-01-07 |
Class II
|
Ongoing |
Z-1401-2026 |
Medline Convenience Kits: 1) KIT ACES INSERT PEG, Model Number: DYKMBNDL130; 2) KIT ACES INSERT PEG, Model Number: DY… |
— |
Medline has identified issues related to calibration of the equipment used to sterilize and package the devices. All products were exposed to the validated ster… |
| 2026-01-07 |
Class II
|
Ongoing |
Z-1400-2026 |
Medline Convenience Kits: 1) TOTE ABRAMS KNEE ARTHROSCOPY, Model Number: DYKM1801B; 2) TOTE SEN OSC HAND REPAIR, Mode… |
— |
Medline has identified issues related to calibration of the equipment used to sterilize and package the devices. All products were exposed to the validated ster… |
| 2026-01-07 |
Class II
|
Ongoing |
Z-1399-2026 |
Medline Convenience Kits: 1) DRAWER 6-IV FLUIDS GLOVES, Model Number: ACC010326; 2) DRAWER 6-IV FLUIDS GLOVES, Model … |
— |
Medline has identified issues related to calibration of the equipment used to sterilize and package the devices. All products were exposed to the validated ster… |
| 2026-01-07 |
Class II
|
Ongoing |
Z-1398-2026 |
Medline Convenience Kits: 1) LITHOTOMY PACK, Model Number: DYNJ83185; 2) LITHOTOMY PACK, Model Number: DYNJ83185A; |
— |
Medline has identified issues related to calibration of the equipment used to sterilize and package the devices. All products were exposed to the validated ster… |
| 2026-01-07 |
Class II
|
Ongoing |
Z-1397-2026 |
Medline Convenience Kits: 1) PLASTIC BIN W/MISC KITS, Model Number: ACC010499; 2) KIT UROLOGY URETHROPLASTY, Model Nu… |
— |
Medline has identified issues related to calibration of the equipment used to sterilize and package the devices. All products were exposed to the validated ster… |
| 2026-01-07 |
Class II
|
Ongoing |
Z-1396-2026 |
Medline Convenience Kits: 1) BAPTIST FLOYD ENDO GI KIT, Model Number: DYKE1455B; 2) GI LAB OTHER ENDO KIT, Model Numb… |
— |
Medline has identified issues related to calibration of the equipment used to sterilize and package the devices. All products were exposed to the validated ster… |
| 2026-01-07 |
Class II
|
Ongoing |
Z-1395-2026 |
Medline Convenience Kits: 1) MAJOR LAPAROTOMY CDS, Model Number: CDS860015U; 2) MAJOR LAPAROTOMY CDS, Model Number: C… |
— |
Medline has identified issues related to calibration of the equipment used to sterilize and package the devices. All products were exposed to the validated ster… |
| 2026-01-07 |
Class II
|
Ongoing |
Z-1394-2026 |
Medline Convenience Kits: 1) CHP COCHLEAR SUPPLEMENT CDS, Model Number: CDS983069G; 2) CHP COCHLEAR SUPPLEMENT CDS, M… |
— |
Medline has identified issues related to calibration of the equipment used to sterilize and package the devices. All products were exposed to the validated ster… |
| 2026-01-07 |
Class II
|
Ongoing |
Z-1393-2026 |
Medline Convenience Kits: 1) DENTAL PACK, Model Number: DYNDA3003 |
— |
Medline has identified issues related to calibration of the equipment used to sterilize and package the devices. All products were exposed to the validated ster… |
| 2026-01-07 |
Class II
|
Ongoing |
Z-1392-2026 |
Medline Convenience Kits: 1) KIT SURG ONC EXCISION BREAST, Model Number: DYKMBNDL84A; 2) KIT SURG ONC EXPLORATORY LAP… |
— |
Medline has identified issues related to calibration of the equipment used to sterilize and package the devices. All products were exposed to the validated ster… |
| 2026-01-07 |
Class II
|
Ongoing |
Z-1391-2026 |
Medline Convenience Kits: 1) PICC LINE TRAY, Model Number: 00-401993O; 2) CODE CART ADULT 4 CENTRAL LINE, Model Numbe… |
— |
Medline has identified issues related to calibration of the equipment used to sterilize and package the devices. All products were exposed to the validated ster… |
| 2026-01-07 |
Class II
|
Ongoing |
Z-1390-2026 |
Medline Convenience Kits: 1) OPEN HEART CDS, Model Number: CDS840015AQ; 2) OPEN HEART CDS, Model Number: CDS840023T; … |
— |
Medline has identified issues related to calibration of the equipment used to sterilize and package the devices. All products were exposed to the validated ster… |
| 2026-01-07 |
Class II
|
Ongoing |
Z-1389-2026 |
Medline Convenience Kits: 1) OR ARTERIOGRAM, Model Number: CDS985094F; 2) KIT SURG ONC LAP DIAG/CV CATH, Model Number… |
— |
Medline has identified issues related to calibration of the equipment used to sterilize and package the devices. All products were exposed to the validated ster… |
| 2026-01-07 |
Class II
|
Ongoing |
Z-1388-2026 |
Medline Convenience Kits: 1) ENDO KIT W/SYRINGE, Model Number: DYKE1743; 2) BGMC ANGIOGRAPHY PACK-LF, Model Number: D… |
— |
Medline has identified issues related to calibration of the equipment used to sterilize and package the devices. All products were exposed to the validated ster… |
| 2026-01-07 |
Class II
|
Ongoing |
Z-1387-2026 |
Medline Convenience Kits: 1) BASIC NERVE BLOCK TRAY W/LINEN, Model Number: PAIN0150C |
— |
Medline has identified issues related to calibration of the equipment used to sterilize and package the devices. All products were exposed to the validated ster… |
| 2026-01-07 |
Class II
|
Ongoing |
Z-1386-2026 |
Medline Convenience Kits: 1) SCC RF PAIN MGMT, Model Number: DYNJ56436A; 2) SCC RF PAIN MGMT, Model Number: DYNJ56436… |
— |
Medline has identified issues related to calibration of the equipment used to sterilize and package the devices. All products were exposed to the validated ster… |
| 2026-01-07 |
Class II
|
Ongoing |
Z-1385-2026 |
Medline Convenience Kits: 1) KIT STC TRACHEOSTOMY, Model Number: DYKMBNDL55; 2) KIT STC TRACHEOSTOMY, Model Number: D… |
— |
Medline has identified issues related to calibration of the equipment used to sterilize and package the devices. All products were exposed to the validated ster… |
| 2026-01-07 |
Class II
|
Ongoing |
Z-1384-2026 |
Medline Convenience Kits: 1) ANCILLARY PACK-LF, Model Number: DYNJ0185290G; 2) OPEN HEART ANESTHESIA ICC-A, Model Num… |
— |
Medline has identified issues related to calibration of the equipment used to sterilize and package the devices. All products were exposed to the validated ster… |
| 2026-01-05 |
Class II
|
Ongoing |
Z-1435-2026 |
Meijer STERILE saline wound wash, First Aid Cleansing Spray, 0.9% USP SODIUM CHLORIDE, 7.1FL OZ (210 mL), DBD-CAN,SPRAY,… |
— |
Medline has identified that the manufacturer of the sterile saline wound wash may not have manufactured products to meet the minimum required sterility assuranc… |
| 2026-01-05 |
Class II
|
Ongoing |
Z-1434-2026 |
Medline Convenience Kits: 1) NAIL KIT, Model Number: DYKM1528 |
— |
Medline has identified that the manufacturer of the sterile saline wound wash may not have manufactured products to meet the minimum required sterility assuranc… |
| 2026-01-05 |
Class II
|
Ongoing |
Z-1433-2026 |
Medline Convenience Kits: 1) TRUNK KIT W/EXPIRATION, Model Number: DYKM1361A; 2) TRUNK KIT 1EA, Model Number: DYKM201… |
— |
Medline has identified that the manufacturer of the sterile saline wound wash may not have manufactured products to meet the minimum required sterility assuranc… |
| 2026-01-05 |
Class II
|
Ongoing |
Z-1432-2026 |
Medline Convenience Kits: 1) NAIL KIT, Model Number: POD14214 |
— |
Medline has identified that the manufacturer of the sterile saline wound wash may not have manufactured products to meet the minimum required sterility assuranc… |
| 2026-01-05 |
Class II
|
Ongoing |
Z-1431-2026 |
Medline Sterile Saline Wound Wash, Cleansing & Wound Irrigation, USP Normal Saline (0.9% Sodium Chloride), 7.1 FL OZ (21… |
— |
Medline has identified that the manufacturer of the sterile saline wound wash may not have manufactured products to meet the minimum required sterility assuranc… |
| 2025-12-31 |
Class II
|
Ongoing |
Z-1366-2026 |
Medline Industries IV Administration and Extension Sets: 1) DBD-IV ADMIN SET,60DRP,1NEEDLE-FREE VALV, Model Number: DYN… |
— |
Under circumstances involving exposure to particular chemicals and mechanical forces, the male luer connectors for the specified IV Administration and Extension… |
| 2025-12-24 |
Class II
|
Ongoing |
Z-1336-2026 |
Medline medical convenience kits packaged as: MERCY CIRCUMCISION TRAY, Kit SKU CIT6135B |
— |
Medline Industries, LP is issuing a recall for specific items and lots of Medline Kits containing BD ChloraPrep Triple Swabsticks which BD determined may exhibi… |
| 2025-12-24 |
Class II
|
Ongoing |
Z-1335-2026 |
Medline medical convenience kits packaged as: STERILE RESUTURE PACK, Kit SKU DYNDL1980A |
— |
Medline Industries, LP is issuing a recall for specific items and lots of Medline Kits containing BD ChloraPrep Triple Swabsticks which BD determined may exhibi… |
| 2025-12-24 |
Class II
|
Ongoing |
Z-1334-2026 |
Medline medical convenience kits packaged as: ) LVAD DRESSING CHANGE TRAY, Kit SKU DM320C; 2) PORT AND IO ACCESS DR… |
— |
Medline Industries, LP is issuing a recall for specific items and lots of Medline Kits containing BD ChloraPrep Triple Swabsticks which BD determined may exhibi… |
| 2025-12-24 |
Class II
|
Ongoing |
Z-1333-2026 |
Medline medical convenience kits packaged as: BLOOD CULTURE KIT NS, Kit SKU DYNDH2088 |
— |
Medline Industries, LP is issuing a recall for specific items and lots of Medline Kits containing BD ChloraPrep Triple Swabsticks which BD determined may exhibi… |
| 2025-12-24 |
Class II
|
Ongoing |
Z-1332-2026 |
Medline medical convenience kits packaged as: SUTURE REMOVAL TRAY, Kit SKU DYNDR1277A |
— |
Medline Industries, LP is issuing a recall for specific items and lots of Medline Kits containing BD ChloraPrep Triple Swabsticks which BD determined may exhibi… |
| 2025-12-24 |
Class II
|
Ongoing |
Z-1331-2026 |
Medline medical convenience kits packaged as: 1) POWERGLIDE DRESSING CHANGE KIT, Kit SKU DYNDH1576; 2) CENTRAL LINE… |
— |
Medline Industries, LP is issuing a recall for specific items and lots of Medline Kits containing BD ChloraPrep Triple Swabsticks which BD determined may exhibi… |
| 2025-12-24 |
Class II
|
Ongoing |
Z-1330-2026 |
1) UNIVERSAL KIT, Kit SKU DT22010B; 2) VAD ACCESS KIT, Kit SKU DT22790C; 3) VAD ACCESS KIT, Kit SKU DT22790C; 4) P… |
— |
Medline Industries, LP is issuing a recall for specific items and lots of Medline Kits containing BD ChloraPrep Triple Swabsticks which BD determined may exhibi… |
| 2025-12-24 |
Class II
|
Ongoing |
Z-1329-2026 |
Medline medical convenience kits packaged as: 1) CANCER SERVICE PORT KIT, Kit SKU DT22710; 2) LINE KIT, Kit SKU DYN… |
— |
Medline Industries, LP is issuing a recall for specific items and lots of Medline Kits containing BD ChloraPrep Triple Swabsticks which BD determined may exhibi… |
| 2025-12-24 |
Class II
|
Ongoing |
Z-1328-2026 |
Medline medical convenience kits packaged as: PEDIATRIC CATH SECUREMENT DRSG, Kit SKU DYNDC3108 |
— |
Medline Industries, LP is issuing a recall for specific items and lots of Medline Kits containing BD ChloraPrep Triple Swabsticks which BD determined may exhibi… |
| 2025-12-24 |
Class II
|
Ongoing |
Z-1327-2026 |
Medline medical convenience kits packaged as: ADULT CATH SECUREMENT DRSG, Kit SKU DYNDC3109 |
— |
Medline Industries, LP is issuing a recall for specific items and lots of Medline Kits containing BD ChloraPrep Triple Swabsticks which BD determined may exhibi… |
| 2025-12-24 |
Class II
|
Ongoing |
Z-1326-2026 |
Medline medical convenience kits packaged as: ANESTHESIA ARTLINE PACK, Kit SKU DYNJ47387B |
— |
Medline Industries, LP is issuing a recall for specific items and lots of Medline Kits containing BD ChloraPrep Triple Swabsticks which BD determined may exhibi… |
| 2025-12-24 |
Class II
|
Ongoing |
Z-1313-2026 |
Intubation Tray (Adult) containing Suction Catheter Kits SKU DYNJAA245B |
— |
A smaller open suction catheter, the 8 Fr Suction Catheter, may have been packed within the kit instead of the required 14 Fr Suction Catheter. Use of the small… |
| 2025-12-24 |
Class II
|
Ongoing |
Z-1312-2026 |
Medline 14 Fr Suction Catheter Kits SKU DYND40972 - respiratory convenience kit |
— |
A smaller open suction catheter, the 8 Fr Suction Catheter, may have been packed within the kit instead of the required 14 Fr Suction Catheter. Use of the small… |
| 2025-12-22 |
Class I
|
Ongoing |
Z-1325-2026 |
Reprocessed Siemens ACUSON AcuNav Diagnostic Ultrasound Catheters: ACUSON AcuNav Ultrasound Catheter, Use on GE Syste… |
— |
These lots of reprocessed catheters may contain small particles of residual material. If affected devices are used, there is a risk of inflammatory response, sy… |
| 2025-12-22 |
Class I
|
Ongoing |
Z-1324-2026 |
Reprocessed Biosense Webster SOUNDSTAR eco Diagnostic Ultrasound Catheters: Biosense Webster SOUNDSTAR eco Diagnostic… |
— |
These lots of reprocessed catheters may contain small particles of residual material. If affected devices are used, there is a risk of inflammatory response, sy… |
| 2025-12-22 |
Class I
|
Ongoing |
Z-1323-2026 |
Medline ReNewal Reprocessed ViewFlex Xtra ICE Catheters: ViewFlex Xtra ICE Catheter 9F x 90cm D087031RH 20197344019… |
— |
These lots of reprocessed catheters may contain small particles of residual material. If affected devices are used, there is a risk of inflammatory response, sy… |
| 2025-12-22 |
Class I
|
Ongoing |
Z-1322-2026 |
Reprocessed St. Jude Supreme and Response Diagnostic Electrophysiology Catheters: St. Jude Medical Supreme Diagnostic… |
— |
These lots of reprocessed catheters may contain small particles of residual material. If affected devices are used, there is a risk of inflammatory response, sy… |
| 2025-12-22 |
Class I
|
Ongoing |
Z-1321-2026 |
Reprocessed Livewire Steerable Diagnostic Electrophysiology Catheters: Livewire Steerable Electrophysiology Catheter,… |
— |
These lots of reprocessed catheters may contain small particles of residual material. If affected devices are used, there is a risk of inflammatory response, sy… |
| 2025-12-22 |
Class I
|
Ongoing |
Z-1320-2026 |
Reprocessed Abbott Inquiry Steerable Diagnostic Catheters: Abbott Inquiry Steerable Diagnostic Catheter 10 Elec. 2-… |
— |
These lots of reprocessed catheters may contain small particles of residual material. If affected devices are used, there is a risk of inflammatory response, sy… |
| 2025-12-22 |
Class I
|
Ongoing |
Z-1319-2026 |
Medline ReNewal Reprocessed Webster CS Catheters: Webster CS Catheter 10 Electrodes 2-8-2mm Spacing w/AutoID w/ EZ St… |
— |
These lots of reprocessed catheters may contain small particles of residual material. If affected devices are used, there is a risk of inflammatory response, sy… |
| 2025-12-16 |
Class II
|
Ongoing |
Z-1090-2026 |
Medline medical procedure convenience kits labeled as: KIT ROBOTICS UROLOGY PROSTATE, REF DYKMBNDL116G |
— |
Medline kits containing Stryker's Strykeflow 2 Suction Irrigators due to a change in design in 2024, irrigation solution is able to travel to the handpiece and … |
| 2025-12-16 |
Class II
|
Ongoing |
Z-1089-2026 |
Medline medical procedure convenience kits labeled as: 1) LAVH PROCEDURE, REF CDS980754T; 2) GYN LAP HYSTERECTOMY C… |
— |
Medline kits containing Stryker's Strykeflow 2 Suction Irrigators due to a change in design in 2024, irrigation solution is able to travel to the handpiece and … |
| 2025-12-16 |
Class II
|
Ongoing |
Z-1088-2026 |
Medline medical procedure convenience kits labeled as: 1) ROBOTIC, REF CDS980523M; 2) ROBOTIC GYN, REF CDS980647K; … |
— |
Medline kits containing Stryker's Strykeflow 2 Suction Irrigators due to a change in design in 2024, irrigation solution is able to travel to the handpiece and … |
| 2025-12-16 |
Class II
|
Ongoing |
Z-1087-2026 |
Medline medical procedure convenience kits labeled as: 1) WCH BARI-GASTRECTOMY CDS, REF CDS860237AF; 2) ROBOTIC PRO… |
— |
Medline kits containing Stryker's Strykeflow 2 Suction Irrigators due to a change in design in 2024, irrigation solution is able to travel to the handpiece and … |
| 2025-12-16 |
Class II
|
Ongoing |
Z-1086-2026 |
Medline medical procedure convenience kits labeled as: 1) LAPAROSCOPY CDS-LF, REF CDS860235L; 2) GENERAL LAPAROSCOP… |
— |
Medline kits containing Stryker's Strykeflow 2 Suction Irrigators due to a change in design in 2024, irrigation solution is able to travel to the handpiece and … |
| 2025-12-16 |
Class II
|
Ongoing |
Z-1085-2026 |
Medline medical procedure convenience kits labeled as: 1) THORACIC ROBOTICS, REF DYNJ908777B; 2) CARDIAC ROBOTIC WH… |
— |
Medline kits containing Stryker's Strykeflow 2 Suction Irrigators due to a change in design in 2024, irrigation solution is able to travel to the handpiece and … |
| 2025-12-12 |
Class II
|
Ongoing |
Z-1200-2026 |
Medline medical procedure convenience kits labeled as: 1) WATKINS SPINE PACK-LF, Kit SKU DYNJ0275635M; 2) SM-SPINE … |
— |
Medline kits were manufactured and distributed containing MASTISOL liquid adhesive which was recalled due to complaints that the butyrate tubing cracked during … |
| 2025-12-12 |
Class II
|
Ongoing |
Z-1199-2026 |
Medline medical procedure convenience kits labeled as: 1) C-SECTION PACK, Kit SKU DYNJ35494C; 2) SMJ C-SECTION PACK… |
— |
Medline kits were manufactured and distributed containing MASTISOL liquid adhesive which was recalled due to complaints that the butyrate tubing cracked during … |
| 2025-12-12 |
Class II
|
Ongoing |
Z-1198-2026 |
Medline medical procedure convenience kits labeled as: CIRCUMCISION PACK, Kit SKU DYNJ16826O |
— |
Medline kits were manufactured and distributed containing MASTISOL liquid adhesive which was recalled due to complaints that the butyrate tubing cracked during … |
| 2025-12-12 |
Class II
|
Ongoing |
Z-1197-2026 |
Medline medical procedure convenience kits labeled as: 1) RR-GYN LAPAROSCOPY PACK-LF, Kit SKU DYNJ0395022O; 2) PELV… |
— |
Medline kits were manufactured and distributed containing MASTISOL liquid adhesive which was recalled due to complaints that the butyrate tubing cracked during … |
| 2025-12-12 |
Class II
|
Ongoing |
Z-1196-2026 |
Medline medical procedure convenience kits labeled as: 1) DEPAUL BASIC NEURO-LF, Kit SKU DYNJ20028L; 2) NEURO MINOR… |
— |
Medline kits were manufactured and distributed containing MASTISOL liquid adhesive which was recalled due to complaints that the butyrate tubing cracked during … |
| 2025-12-12 |
Class II
|
Ongoing |
Z-1195-2026 |
Medline medical procedure convenience kits labeled as: 1) INPATIENT CTRL LN DRG CHG, Kit SKU DT22880; 2) ADULT CVC … |
— |
Medline kits were manufactured and distributed containing MASTISOL liquid adhesive which was recalled due to complaints that the butyrate tubing cracked during … |
| 2025-12-12 |
Class II
|
Ongoing |
Z-1194-2026 |
Medline medical procedure convenience kits labeled as: HEAD SHAVE-LATEX SAFE KIT, Kit SKU P903933B |
— |
Medline kits were manufactured and distributed containing MASTISOL liquid adhesive which was recalled due to complaints that the butyrate tubing cracked during … |
| 2025-12-12 |
Class II
|
Ongoing |
Z-1193-2026 |
Medline medical procedure convenience kits labeled as: 1) DRAWER 1 AIRWAY, Kit SKU ACC010270A; 2) DRAWER 2, Kit SKU… |
— |
Medline kits were manufactured and distributed containing MASTISOL liquid adhesive which was recalled due to complaints that the butyrate tubing cracked during … |
| 2025-12-12 |
Class II
|
Ongoing |
Z-1192-2026 |
Medline medical procedure convenience kits labeled as: 1) MEM MAXILLOFACIAL PACK-LF, Kit SKU DYNJ0660040R; 2) PLAST… |
— |
Medline kits were manufactured and distributed containing MASTISOL liquid adhesive which was recalled due to complaints that the butyrate tubing cracked during … |
| 2025-12-12 |
Class II
|
Ongoing |
Z-1191-2026 |
Medline medical procedure convenience kits labeled as: 1) SMJ LAP CHOLE PACK-LF, Kit SKU DYNJ19974P; 2) DEPAUL ABDO… |
— |
Medline kits were manufactured and distributed containing MASTISOL liquid adhesive which was recalled due to complaints that the butyrate tubing cracked during … |
| 2025-12-12 |
Class II
|
Ongoing |
Z-1190-2026 |
Medline medical procedure convenience kits labeled as: 1) MIDDLE EAR CDS, Kit SKU CDS984347O; 2) HEAD AND NECK CDS-… |
— |
Medline kits were manufactured and distributed containing MASTISOL liquid adhesive which was recalled due to complaints that the butyrate tubing cracked during … |
| 2025-12-12 |
Class II
|
Ongoing |
Z-1189-2026 |
Medline medical procedure convenience kits labeled as: 1) BREAST-HERNIA-PORT CDS-LF, Kit SKU CDS984853L; 2) BREAST … |
— |
Medline kits were manufactured and distributed containing MASTISOL liquid adhesive which was recalled due to complaints that the butyrate tubing cracked during … |
| 2025-12-12 |
Class II
|
Ongoing |
Z-1188-2026 |
Medline medical procedure convenience kits labeled as: 1) PACER / CATH LAB PACK-LF, Kit SKU DYNJ0972604A; 2) PACEMA… |
— |
Medline kits were manufactured and distributed containing MASTISOL liquid adhesive which was recalled due to complaints that the butyrate tubing cracked during … |
| 2025-12-12 |
Class II
|
Ongoing |
Z-1187-2026 |
Medline medical procedure convenience kits labeled as: 1) CATH LAB PACEMAKER PACK-LF, Kit SKU DYNJ64837C; 2) LOOP R… |
— |
Medline kits were manufactured and distributed containing MASTISOL liquid adhesive which was recalled due to complaints that the butyrate tubing cracked during … |
| 2025-12-12 |
Class II
|
Ongoing |
Z-1186-2026 |
Medline medical procedure convenience kits labeled as: NERVE BLOCK TRAY 2, Kit SKU DYNJRA2713 |
— |
Medline kits were manufactured and distributed containing MASTISOL liquid adhesive which was recalled due to complaints that the butyrate tubing cracked during … |
| 2025-11-26 |
Class II
|
Ongoing |
Z-1060-2026 |
Medline Kits containing B. Braun IV Administration Sets and Pump Administration Sets, labeled as: 1) RR-PLASTIC CRANIO… |
— |
Medline kits contain B. Braun IV Administration Sets and Pump Administration Sets which were recalled due to customer complaints identifying that the check valv… |
| 2025-11-26 |
Class II
|
Ongoing |
Z-1059-2026 |
Medline Kits containing B. Braun IV Administration Sets and Pump Administration Sets, labeled as: NEURO ANGIO PACK, M… |
— |
Medline kits contain B. Braun IV Administration Sets and Pump Administration Sets which were recalled due to customer complaints identifying that the check valv… |
| 2025-11-26 |
Class II
|
Ongoing |
Z-1058-2026 |
Medline Kits containing B. Braun IV Administration Sets and Pump Administration Sets, labeled as: 1) ADMIN KIT, Medl… |
— |
Medline kits contain B. Braun IV Administration Sets and Pump Administration Sets which were recalled due to customer complaints identifying that the check valv… |
| 2025-11-26 |
Class II
|
Ongoing |
Z-1057-2026 |
Medline Kits containing B. Braun IV Administration Sets and Pump Administration Sets, labeled as: 1) PRE OP KIT, Medl… |
— |
Medline kits contain B. Braun IV Administration Sets and Pump Administration Sets which were recalled due to customer complaints identifying that the check valv… |
| 2025-11-26 |
Class II
|
Ongoing |
Z-1056-2026 |
Medline Kits containing B. Braun IV Administration Sets and Pump Administration Sets, labeled as: 1) IV START KIT NS,… |
— |
Medline kits contain B. Braun IV Administration Sets and Pump Administration Sets which were recalled due to customer complaints identifying that the check valv… |
| 2025-11-26 |
Class II
|
Ongoing |
Z-1055-2026 |
Medline Kits containing B. Braun IV Administration Sets and Pump Administration Sets, labeled as: 1) DRAWER 2 IV SUPP… |
— |
Medline kits contain B. Braun IV Administration Sets and Pump Administration Sets which were recalled due to customer complaints identifying that the check valv… |
| 2025-11-26 |
Class II
|
Ongoing |
Z-1054-2026 |
Medline Kits containing B. Braun IV Administration Sets and Pump Administration Sets, labeled as: DR HOLCOMB FACIAL P… |
— |
Medline kits contain B. Braun IV Administration Sets and Pump Administration Sets which were recalled due to customer complaints identifying that the check valv… |
| 2025-11-26 |
Class II
|
Ongoing |
Z-1053-2026 |
Medline Kits containing B. Braun IV Administration Sets and Pump Administration Sets, labeled as: RR-LAP DONOR NEP AC… |
— |
Medline kits contain B. Braun IV Administration Sets and Pump Administration Sets which were recalled due to customer complaints identifying that the check valv… |
| 2025-11-26 |
Class II
|
Ongoing |
Z-1052-2026 |
Medline Kits containing B. Braun IV Administration Sets and Pump Administration Sets, labeled as: 1) RR-LE FORT MANDI… |
— |
Medline kits contain B. Braun IV Administration Sets and Pump Administration Sets which were recalled due to customer complaints identifying that the check valv… |
| 2025-11-26 |
Class II
|
Ongoing |
Z-1051-2026 |
Medline Kits containing B. Braun IV Administration Sets and Pump Administration Sets, labeled as: 1) DELUXE PRE OP KI… |
— |
Medline kits contain B. Braun IV Administration Sets and Pump Administration Sets which were recalled due to customer complaints identifying that the check valv… |
| 2025-11-26 |
Class II
|
Ongoing |
Z-1050-2026 |
Medline Kits containing B. Braun IV Administration Sets and Pump Administration Sets, labeled as: 1) OPEN HEART ACCES… |
— |
Medline kits contain B. Braun IV Administration Sets and Pump Administration Sets which were recalled due to customer complaints identifying that the check valv… |
| 2025-11-26 |
Class II
|
Ongoing |
Z-1049-2026 |
Medline Kits containing B. Braun IV Administration Sets and Pump Administration Sets, labeled as: AN01 CAROTID ANESTH K… |
— |
Medline kits contain B. Braun IV Administration Sets and Pump Administration Sets which were recalled due to customer complaints identifying that the check valv… |
| 2025-11-26 |
Class I
|
Ongoing |
Z-1016-2026 |
MEDLINE beds labeled as: Full Electric Low Lightweight Homecare Bed, REF MDR107003LO |
— |
Medline Industries has identified a potential hazard involving the hand control pendant and associated wires. In rare and atypical scenarios such as operating t… |
| 2025-11-26 |
Class I
|
Ongoing |
Z-1015-2026 |
MEDLINE beds labeled as: Full Electric Lightweight Homecare Bed, REF MDR107003L |
— |
Medline Industries has identified a potential hazard involving the hand control pendant and associated wires. In rare and atypical scenarios such as operating t… |
| 2025-11-26 |
Class I
|
Ongoing |
Z-1014-2026 |
MEDLINE beds labeled as: Full Electric Low Basic Homecare Bed, REF MDR107003ELO |
— |
Medline Industries has identified a potential hazard involving the hand control pendant and associated wires. In rare and atypical scenarios such as operating t… |
| 2025-11-26 |
Class I
|
Ongoing |
Z-1013-2026 |
MEDLINE beds labeled as: 1) Full Electric Basic Homecare Bed, REF MDR107003E; 2) Full Electric Basic Homecare Bed, 4-pac… |
— |
Medline Industries has identified a potential hazard involving the hand control pendant and associated wires. In rare and atypical scenarios such as operating t… |
| 2025-11-26 |
Class I
|
Ongoing |
Z-1012-2026 |
MEDLINE beds labeled as: Semi Electric Lightweight Homecare Bed, REF MDR107002L |
— |
Medline Industries has identified a potential hazard involving the hand control pendant and associated wires. In rare and atypical scenarios such as operating t… |
| 2025-11-26 |
Class I
|
Ongoing |
Z-1011-2026 |
MEDLINE beds labeled as: 1) Semi Electric Basic Homecare Bed, REF MDR107002E; 2) Semi Electric Basic Homecare Bed, 4-pac… |
— |
Medline Industries has identified a potential hazard involving the hand control pendant and associated wires. In rare and atypical scenarios such as operating t… |
| 2025-11-21 |
Class II
|
Ongoing |
Z-1035-2026 |
Medline Hudson RCI Medium Concentration Oxygen Masks: 1041CE MASK,OXYGEN,UND CHIN,MED CO OUS ONLY; HUD1035 O2 MASK… |
— |
Firm received multiple complaints regarding tubing disconnecting from oxygen mask. If issue occurs during use, may lead to delay in patient care and patient may… |
| 2025-11-13 |
Class II
|
Ongoing |
Z-0922-2026 |
FORCEP, STD STR, STERILE KELLY, 5.5 IN, Item Number DYNJ04048 |
— |
The items may have weak packaging seals that may result in a breach of sterility if the seal fails and may lead to an increased risk of infection if product is … |
| 2025-11-13 |
Class II
|
Ongoing |
Z-0921-2026 |
SCISSORS, OR, SHARP/BLUNT, 5.5", STERILE, Item Number DYND04000 |
— |
The items may have weak packaging seals that may result in a breach of sterility if the seal fails and may lead to an increased risk of infection if product is … |
| 2025-11-11 |
Class II
|
Ongoing |
Z-0911-2026 |
DEXLOCK Achilles Repair Implant Kits, MAKT4520 |
— |
There have been multiple complaints of drill bit fusing to the bushing/sleeve within the drill guide during use. Retrieving a replacement drill bit and drill gu… |
| 2025-10-27 |
Class II
|
Ongoing |
Z-0904-2026 |
Quick Strip Fabric Sterile Adhesive Bandages, 1" x 3", Medline Item Number NON25660QS |
— |
Medline has identified that all lots of the Curad Touch-Free and Quick-Strip Bandages may exhibit open seals in the packaging which may compromise the sterility… |
| 2025-10-27 |
Class II
|
Ongoing |
Z-0903-2026 |
Quick Strip Fabric Sterile Adhesive Bandages, 0.75" x 3", Medline Item Number NON25650QS |
— |
Medline has identified that all lots of the Curad Touch-Free and Quick-Strip Bandages may exhibit open seals in the packaging which may compromise the sterility… |
| 2025-10-27 |
Class II
|
Ongoing |
Z-0902-2026 |
Fur Friends Plastic Sterile Adhesive Bandages, 0.75" x 3", Medline Item Number NON256133QS |
— |
Medline has identified that all lots of the Curad Touch-Free and Quick-Strip Bandages may exhibit open seals in the packaging which may compromise the sterility… |
| 2025-10-27 |
Class II
|
Ongoing |
Z-0901-2026 |
Quick Strip Plastic Sterile Adhesive Bandages, 1" x 3", Medline Item Number NON25600QS |
— |
Medline has identified that all lots of the Curad Touch-Free and Quick-Strip Bandages may exhibit open seals in the packaging which may compromise the sterility… |
| 2025-10-27 |
Class II
|
Ongoing |
Z-0900-2026 |
Quick Strip Plastic Sterile Adhesive Bandages, 0.75" x 3", Medline Item Number NON25500QS |
— |
Medline has identified that all lots of the Curad Touch-Free and Quick-Strip Bandages may exhibit open seals in the packaging which may compromise the sterility… |
| 2025-10-27 |
Class II
|
Ongoing |
Z-0899-2026 |
Curad Quick Strip Fabric Bandages Containing 30 Bandages of 3/4" x 3", Medline Item Number CUR1930P |
— |
Medline has identified that all lots of the Curad Touch-Free and Quick-Strip Bandages may exhibit open seals in the packaging which may compromise the sterility… |
| 2025-10-27 |
Class II
|
Ongoing |
Z-0898-2026 |
CURAD Germ-Shield Touch-Free Fabric Bandages, Sterile, 0.75" x 3", 30/Box, Medline Item Number CUR1930F |
— |
Medline has identified that all lots of the Curad Touch-Free and Quick-Strip Bandages may exhibit open seals in the packaging which may compromise the sterility… |
| 2025-10-27 |
Class II
|
Ongoing |
Z-0886-2026 |
MEDLINE PERFUSION SYRINGE, REF: DYNJ39223C |
— |
Medline Industries, LP is issuing a recall for specific item(s) and lot(s) of Medline Kits containing BD Luer Tip Caps. BD has issued a recall of their Luer Tip… |
| 2025-10-10 |
Class I
|
Ongoing |
Z-0451-2026 |
Convenience kits; DYNJ901047R ORTHO SPINE FUMICH DYNJ902308K TOTAL JOINT DYNJ909111F DR SALMA'S SPINE DYNJ909117G PA… |
— |
Firm received multiple complaints of anesthesia circuit leaks due to cracks in the 120" expandable tubing. Cracks and resulting leaks may lead to hypoxia, hypov… |
| 2025-10-10 |
Class I
|
Ongoing |
Z-0450-2026 |
Convenience kits; DYNJ901046M GYN ROBOTIC DYNJ909120D ROBOTIC PROSTATE |
— |
Firm received multiple complaints of anesthesia circuit leaks due to cracks in the 120" expandable tubing. Cracks and resulting leaks may lead to hypoxia, hypov… |
| 2025-10-10 |
Class I
|
Ongoing |
Z-0449-2026 |
Anesthesia circuit kit; CIRCUIT,ANES,EXTENDFLEX,120,LF DYNJAA10230 |
— |
Firm received multiple complaints of anesthesia circuit leaks due to cracks in the 120" expandable tubing. Cracks and resulting leaks may lead to hypoxia, hypov… |
| 2025-10-10 |
Class I
|
Ongoing |
Z-0448-2026 |
Convenience Kits: DYNJ901048N ORTHO SPINE ST CLAIR DYNJ909123F UROLOGY MINOR DYNJ909132F SET UP DYNJ909308D HIP PINN… |
— |
Firm received multiple complaints of anesthesia circuit leaks due to cracks in the 120" expandable tubing. Cracks and resulting leaks may lead to hypoxia, hypov… |
| 2025-10-10 |
Class I
|
Ongoing |
Z-0447-2026 |
Convenience Kit, BREAST HERNIA DYNJ909125G |
— |
Firm received multiple complaints of anesthesia circuit leaks due to cracks in the 120" expandable tubing. Cracks and resulting leaks may lead to hypoxia, hypov… |
| 2025-10-10 |
Class I
|
Ongoing |
Z-0446-2026 |
DYNJ909119G ROBOTIC GASTRIC LAP SLEEVE-LF DYNJ909127F CYSTO DYNJ909129D GENERAL LAPAROSCOPY-LF |
— |
Firm received multiple complaints of anesthesia circuit leaks due to cracks in the 120" expandable tubing. Cracks and resulting leaks may lead to hypoxia, hypov… |
| 2025-10-10 |
Class I
|
Ongoing |
Z-0445-2026 |
Anesthesia Circuit Kits and other various kits that contain Anesthesia Circuits; ENT DYNJ909128I; LARYNGOSCOPY - BRON… |
— |
Firm received multiple complaints of anesthesia circuit leaks due to cracks in the 120" expandable tubing. Cracks and resulting leaks may lead to hypoxia, hypov… |
| 2025-10-10 |
Class I
|
Ongoing |
Z-0444-2026 |
Anesthesia Circuit Kits and other various kits that contain Anesthesia Circuits; OPEN HEART SUPPLEMENT DYNJ909116D; V… |
— |
Firm received multiple complaints of anesthesia circuit leaks due to cracks in the 120" expandable tubing. Cracks and resulting leaks may lead to hypoxia, hypov… |
| 2025-10-10 |
Class I
|
Ongoing |
Z-0443-2026 |
Anesthesia Circuit Kits and other various kits that contain Anesthesia Circuits; BREATHING KIT-LF DYNJ10550 |
— |
Firm received multiple complaints of anesthesia circuit leaks due to cracks in the 120" expandable tubing. Cracks and resulting leaks may lead to hypoxia, hypov… |
| 2025-10-10 |
Class I
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Ongoing |
Z-0442-2026 |
Anesthesia Circuit Kits and other various kits that contain Anesthesia Circuits; Product description/Product numbers:… |
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Firm received multiple complaints of anesthesia circuit leaks due to cracks in the 120" expandable tubing. Cracks and resulting leaks may lead to hypoxia, hypov… |
| 2025-10-03 |
Class II
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Ongoing |
Z-0510-2026 |
MEDLINE STERILE BASIC EYE PACK 16: 1) REF: DYNJ37743D; 2) REF: DYNJ37743F. |
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Medline has identified specific sterile eye procedure kits with pouch packaging that may exhibit open seals. |
| 2025-10-01 |
Class II
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Ongoing |
Z-0477-2026 |
Medline Renewal Ligasure Maryland Jaw Sealer/Divider NanoCoated, Compatible with FT10 Generator 44 cm FT10 SW Version 4.… |
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Medline Renewal has determined that certain areas on the device have the potential to trap residual material, which may remain within the device and, in rare ca… |
| 2025-10-01 |
Class II
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Ongoing |
Z-0476-2026 |
Medline Renewal LigaSure Maryland Jaw Sealer/Divider NanoCoated, Compatible w/FT10 37 cm FT10 SW Version 4.0.1.15 or low… |
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Medline Renewal has determined that certain areas on the device have the potential to trap residual material, which may remain within the device and, in rare ca… |
| 2025-10-01 |
Class II
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Ongoing |
Z-0475-2026 |
Medline Renewal LigaSure Maryland Jaw Sealer/Divider Nano Coated, Compatible with FT10 Generator 23 cm FT10 SW Version 4… |
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Medline Renewal has determined that certain areas on the device have the potential to trap residual material, which may remain within the device and, in rare ca… |
| 2025-10-01 |
Class II
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Ongoing |
Z-0474-2026 |
Medline Renewal Ligasure Blunt Tip Sealer/Divider NanoCoated, Compatible with FT10 Generator 44cm FT10 SW Version 4.0.1.… |
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Medline Renewal has determined that certain areas on the device have the potential to trap residual material, which may remain within the device and, in rare ca… |
| 2025-10-01 |
Class II
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Ongoing |
Z-0473-2026 |
Medline Renewal Ligasure Blunt Tip Sealer/Divider NanoCoated, Compatible with FT10 Generator 37 cm FT10 SW Version 4.0.1… |
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Medline Renewal has determined that certain areas on the device have the potential to trap residual material, which may remain within the device and, in rare ca… |
| 2025-10-01 |
Class II
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Ongoing |
Z-0472-2026 |
Medline RenewalLigasure Blunt Tip Sealer/Divider, NanoCoated Compatible with FT10 Generator 23 cm FT10 SW Version 4.0.1.… |
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Medline Renewal has determined that certain areas on the device have the potential to trap residual material, which may remain within the device and, in rare ca… |
| 2025-10-01 |
Class II
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Ongoing |
Z-0471-2026 |
Medline Renewal LigaSure Blunt Tip Sealer/Divider, Compatible with FT10 Generator, 5 mm x 37 cm FT10 SW Version 4.0.1.15… |
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Medline Renewal has determined that certain areas on the device have the potential to trap residual material, which may remain within the device and, in rare ca… |
| 2025-10-01 |
Class II
|
Ongoing |
Z-0470-2026 |
Medline Renewal LigaSure Small Jaw Instrument (Purple/White), Compatible with FT10 Generator 18.8 cm FT10 SW Version 4.… |
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Medline Renewal has determined that certain areas on the device have the potential to trap residual material, which may remain within the device and, in rare ca… |
| 2025-10-01 |
Class II
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Ongoing |
Z-0469-2026 |
Medline Renewal Ligasure Impact Sealer/Divider NanoCoated, Compatible with FT10 Generator 18cm FT10 SW Version 4.0.1.15 … |
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Medline Renewal has determined that certain areas on the device have the potential to trap residual material, which may remain within the device and, in rare ca… |
| 2025-10-01 |
Class II
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Ongoing |
Z-0468-2026 |
Medline Renewal LigaSure Impact Curved Large Jaw Sealer/Divider, Compatible with FT10 Generator, FT10 SW Version 4.0.1.1… |
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Medline Renewal has determined that certain areas on the device have the potential to trap residual material, which may remain within the device and, in rare ca… |
| 2025-10-01 |
Class II
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Ongoing |
Z-0467-2026 |
Medline Renewal LigaSure Exact, Dissector without Nano-Coating 21cm FT10 SW Version 4.0.1.15 or lower; Electrosurgical … |
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Medline Renewal has determined that certain areas on the device have the potential to trap residual material, which may remain within the device and, in rare ca… |
| 2025-09-30 |
Class II
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Ongoing |
Z-0530-2026 |
MEDLINE convenience kits labeled as: 1) NEURO CRANIOTOMY CDS #36-RF, REF CDS780119V; 2) BASIC BACK CDS, REF CDS7801… |
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Medline Industries, LP is issuing a recall for specific item(s) and lot(s) of Medline Kits containing SafeAir Smoke Evacuation Pencils. Stryker Instruments has … |
| 2025-09-30 |
Class II
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Ongoing |
Z-0529-2026 |
MEDLINE convenience kits labeled as: 1) MINOR EYE TRAY #81, REF DYNJ27466S; 2) MINOR EYE TRAY #81, REF DYNJ27466T. |
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Medline Industries, LP is issuing a recall for specific item(s) and lot(s) of Medline Kits containing SafeAir Smoke Evacuation Pencils. Stryker Instruments has … |
| 2025-09-30 |
Class II
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Ongoing |
Z-0528-2026 |
MEDLINE convenience kits labeled as: GP-LEEP PACK-LF, REF PHS396969004F |
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Medline Industries, LP is issuing a recall for specific item(s) and lot(s) of Medline Kits containing SafeAir Smoke Evacuation Pencils. Stryker Instruments has … |
| 2025-09-30 |
Class II
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Ongoing |
Z-0527-2026 |
MEDLINE convenience kits labeled as: 1) GYN LAPAROTOMY HARPER PACK-LF, REF DYNJ0160684F; 2) MAJOR LITHOTOMY PACK-LF… |
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Medline Industries, LP is issuing a recall for specific item(s) and lot(s) of Medline Kits containing SafeAir Smoke Evacuation Pencils. Stryker Instruments has … |
| 2025-09-30 |
Class II
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Ongoing |
Z-0526-2026 |
MEDLINE convenience kits labeled as: 1) C-SECTION OR 30 CDS, REF CDS820075W; 2) C-SECTION, REF CDS984261J; 3) C-S… |
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Medline Industries, LP is issuing a recall for specific item(s) and lot(s) of Medline Kits containing SafeAir Smoke Evacuation Pencils. Stryker Instruments has … |
| 2025-09-30 |
Class II
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Ongoing |
Z-0525-2026 |
MEDLINE convenience kits labeled as: CIRCUMCISION PACK, REF DYNJ16826O |
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Medline Industries, LP is issuing a recall for specific item(s) and lot(s) of Medline Kits containing SafeAir Smoke Evacuation Pencils. Stryker Instruments has … |
| 2025-09-30 |
Class II
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Ongoing |
Z-0524-2026 |
MEDLINE convenience kits labeled as: 1) GYN LAPAROSCOPY CDS #34-RF, REF CDS920099S; 2) GYN LAPAROSCOPY CDS-LF, REF … |
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Medline Industries, LP is issuing a recall for specific item(s) and lot(s) of Medline Kits containing SafeAir Smoke Evacuation Pencils. Stryker Instruments has … |
| 2025-09-30 |
Class II
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Ongoing |
Z-0523-2026 |
MEDLINE convenience kits labeled as: 1) MAJOR VAGINAL HARPER PACK-LF, REF DYNJ0161768G; 2) ACH MAJOR VAGINAL PACK, … |
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Medline Industries, LP is issuing a recall for specific item(s) and lot(s) of Medline Kits containing SafeAir Smoke Evacuation Pencils. Stryker Instruments has … |
| 2025-09-30 |
Class II
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Ongoing |
Z-0522-2026 |
MEDLINE convenience kits labeled as: 1) BASIC NEURO PACK, REF CDS780202R; 2) ACDF CDS, REF CDS941061M; 3) NEURO P… |
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Medline Industries, LP is issuing a recall for specific item(s) and lot(s) of Medline Kits containing SafeAir Smoke Evacuation Pencils. Stryker Instruments has … |
| 2025-09-30 |
Class II
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Ongoing |
Z-0521-2026 |
MEDLINE convenience kits labeled as: 1) GENERAL LAPAROSCOPY, REF CDS930027W; 2) GENERAL MAJOR CDS, REF CDS980245X; … |
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Medline Industries, LP is issuing a recall for specific item(s) and lot(s) of Medline Kits containing SafeAir Smoke Evacuation Pencils. Stryker Instruments has … |
| 2025-09-30 |
Class II
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Ongoing |
Z-0520-2026 |
MEDLINE convenience kits labeled as: 1) MINOR SINGLE BASIN PACK, REF DYNJ37698L; 2) BASIN PACK, REF DYNJ50123D; 3… |
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Medline Industries, LP is issuing a recall for specific item(s) and lot(s) of Medline Kits containing SafeAir Smoke Evacuation Pencils. Stryker Instruments has … |
| 2025-09-30 |
Class II
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Ongoing |
Z-0519-2026 |
MEDLINE convenience kits labeled as: 1) ACH PLASTICS BREAST-LF, REF CDS983639K; 2) BREAST ABD, REF CDS984267J; 3)… |
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Medline Industries, LP is issuing a recall for specific item(s) and lot(s) of Medline Kits containing SafeAir Smoke Evacuation Pencils. Stryker Instruments has … |
| 2025-09-30 |
Class II
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Ongoing |
Z-0518-2026 |
MEDLINE convenience kits labeled as: PORT INSERTION PACK, REF DYNJ81597 |
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Medline Industries, LP is issuing a recall for specific item(s) and lot(s) of Medline Kits containing SafeAir Smoke Evacuation Pencils. Stryker Instruments has … |
| 2025-09-30 |
Class II
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Ongoing |
Z-0517-2026 |
MEDLINE convenience kits labeled as: 1) MAJOR LAPAROTOMY CDS, REF CDS860015W; 2) MAJOR LAPAROTOMY CDS, REF CDS86001… |
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Medline Industries, LP is issuing a recall for specific item(s) and lot(s) of Medline Kits containing SafeAir Smoke Evacuation Pencils. Stryker Instruments has … |
| 2025-09-30 |
Class II
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Ongoing |
Z-0516-2026 |
MEDLINE convenience kits labeled as: 1) HEAD AND NECK, REF CDS984259O; 2) HEAD AND NECK, REF CDS984259P; 3) MINOR… |
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Medline Industries, LP is issuing a recall for specific item(s) and lot(s) of Medline Kits containing SafeAir Smoke Evacuation Pencils. Stryker Instruments has … |
| 2025-09-30 |
Class II
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Ongoing |
Z-0515-2026 |
MEDLINE convenience kits labeled as: 1) BREAST BIOPSY PACK-LF, REF DYNJ0160598C; 2) BIOPSY BREAST PACK, REF DYNJ653… |
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Medline Industries, LP is issuing a recall for specific item(s) and lot(s) of Medline Kits containing SafeAir Smoke Evacuation Pencils. Stryker Instruments has … |
| 2025-09-30 |
Class II
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Ongoing |
Z-0514-2026 |
MEDLINE convenience kits labeled as: 1) CENTRAL LINE PACK, REF DYNJ00281P; 2) FREE FLAP PACK, REF DYNJ68213C. |
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Medline Industries, LP is issuing a recall for specific item(s) and lot(s) of Medline Kits containing SafeAir Smoke Evacuation Pencils. Stryker Instruments has … |
| 2025-09-30 |
Class II
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Ongoing |
Z-0513-2026 |
MEDLINE convenience kits labeled as: 1) GENERAL AAA #11-RF, REF CDS840261AB; 2) CAROTID ENDARTERECTOMY CDS-LF, REF … |
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Medline Industries, LP is issuing a recall for specific item(s) and lot(s) of Medline Kits containing SafeAir Smoke Evacuation Pencils. Stryker Instruments has … |
| 2025-09-30 |
Class II
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Ongoing |
Z-0512-2026 |
MEDLINE convenience kits labeled as: CATH LAB PACEMAKER PACK, REF DYNJ59818A |
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Medline Industries, LP is issuing a recall for specific item(s) and lot(s) of Medline Kits containing SafeAir Smoke Evacuation Pencils. Stryker Instruments has … |
| 2025-09-30 |
Class II
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Ongoing |
Z-0511-2026 |
MEDLINE convenience kits labeled as LOCAL BASIC, REF DYNJ34418M |
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Medline Industries, LP is issuing a recall for specific item(s) and lot(s) of Medline Kits containing SafeAir Smoke Evacuation Pencils. Stryker Instruments has … |
| 2025-09-11 |
Class II
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Ongoing |
Z-0234-2026 |
Excelsior Medical, 0.9% Sodium Chloride Injection, USP - 10 mL Fill, Item Number EMZ111240. Prefilled saline flush syri… |
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Medline has identified a limited quantity of saline IV flush syringes that may not meet the required concentration of sodium chloride. |
| 2025-09-10 |
Class II
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Ongoing |
Z-0137-2026 |
Medline Adult Anesthesia Set, REF DYNJ39985G |
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Specific items and lots of Medline Kits may contain Clearlink IV Sets which Baxter recalled due to customer reports of leaking. |
| 2025-08-21 |
Class I
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Ongoing |
Z-2670-2025 |
Medline Kits: 1) VALVE PACK-LF, Model Number: DYNJ0415366P; 2) VALVE PACK-LF, Model Number: DYNJ0415366Q |
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The kits contain certain lots of cannula products where the catheter may not retain its shape. |
| 2025-08-08 |
Class I
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Ongoing |
Z-2593-2025 |
Sterile Medline Convenience Kits: 1) EXTREMITY PACK, Model Number: DYNJ45701B |
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Convenience kits labeled as sterile have not gone through the sterilization process. |
| 2025-08-08 |
Class I
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Ongoing |
Z-2592-2025 |
Sterile Medline Convenience Kits: 1) MAJOR PACK L-F, Model Number: DYNJ0382730O; 2) LB BASIC CUSTOM PACK, Model Numbe… |
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Convenience kits labeled as sterile have not gone through the sterilization process. |
| 2025-07-31 |
Class I
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Ongoing |
Z-2614-2025 |
Reprocessed ACUSON AcuNav Ultrasound Catheter for intracardiac and intra-luminal visualization of cardiac and great vess… |
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Specific lots of reprocessed electrophysiology and ultrasound catheters may contain small residual particulates. If devices with residual particulates on patien… |
| 2025-07-31 |
Class I
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Ongoing |
Z-2613-2025 |
Reprocessed ViewFlex Xtra ICE Catheter to visualize cardiac structures; blood flow and other devices within the heart. M… |
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Specific lots of reprocessed electrophysiology and ultrasound catheters may contain small residual particulates. If devices with residual particulates on patien… |
| 2025-07-31 |
Class I
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Ongoing |
Z-2612-2025 |
Reprocessed Inquiry Steerable Diagnostics Catheter for electrogram recording and cardiac stimulation during diagnostic e… |
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Specific lots of reprocessed electrophysiology and ultrasound catheters may contain small residual particulates. If devices with residual particulates on patien… |
| 2025-07-31 |
Class I
|
Ongoing |
Z-2611-2025 |
Reprocessed Webster CS Catheter 10 Electrodes for electrophysiological mapping of cardiac structures. Medline Item Numbe… |
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Specific lots of reprocessed electrophysiology and ultrasound catheters may contain small residual particulates. If devices with residual particulates on patien… |
| 2025-07-31 |
Class I
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Ongoing |
Z-2610-2025 |
Reprocessed Livewire Steerable Electrophysiology Catheter Item Numbers 401575RH 401582RH 401600RH 401603RH 401606… |
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Specific lots of reprocessed electrophysiology and ultrasound catheters may contain small residual particulates. If devices with residual particulates on patien… |