Chrysalis Intelligence · Sponsors · Medline Industries, Inc.

Medline Industries, Inc.

Northfiled, IL, US · 35 510(k) clearances · 46 recalls

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Total clearances
35
2020-01-10 → 2024-03-27
Last 12 months
0
Product codes
22
Most recent
2024-03-27
Trend

Clearance cadence by quarter

Portfolio

Product codes worked

Code Device name Class Specialty Clearances Most recent
KGO — — — 8 2021-08-02
LZA — — — 4 2020-10-26
LRO — — — 2 2022-05-24
GEI Electrosurgical, Cutting & Coagulation & Accessories Class II General, Plastic Surgery 2 2022-01-14
LYZ — — — 2 2020-10-26
QYK Semi-Automated Autologous Skin Graft Harvesting And Application Device Class II General, Plastic Surgery 1 2024-03-27
BTT Humidifier, Respiratory Gas, (Direct Patient Interface) Class II Anesthesiology 1 2023-10-26
CAF — — — 1 2023-06-27
HRS Plate, Fixation, Bone Class II Orthopedic 1 2023-01-25
FMF — — — 1 2022-12-09
HFX — — — 1 2022-11-18
BWF Spirometer, Therapeutic (Incentive) Class II Anesthesiology 1 2022-10-25
FYD Apparatus, Exhaust, Surgical Class II General, Plastic Surgery 1 2022-01-03
HTN Washer, Bolt Nut Class II Orthopedic 1 2021-12-10
FLL Continuous Measurement Thermometer Class II General Hospital 1 2021-09-20
HWC Screw, Fixation, Bone Class II Orthopedic 1 2021-07-22
BTA — — — 1 2021-05-04
JDR Staple, Fixation, Bone Class II Orthopedic 1 2021-04-22
FYA Gown, Surgical Class II General, Plastic Surgery 1 2021-04-02
PNR Enteral Syringes With Enteral Specific Connectors Class II Gastroenterology, Urology 1 2020-10-09
IPF Stimulator, Muscle, Powered Class II Physical Medicine 1 2020-09-21
FRG Wrap, Sterilization Class II General Hospital 1 2020-01-24
Safety

Recalls (46)

Class I (serious)
0
Risk of injury / death
Total recalls
46
Currently ongoing
6
Most recent
2022-07-21
DateSeverityStatusRecall # ProductCodeReason
2022-07-21 Class II Ongoing Z-1683-2022 Medline CHEST TUBE REORDER NO: DYNJ36762A — Due to a non-sterile component (tape) being place within the sterile portion of the Chest Tube Convenience Kit
2021-10-27 Class II Terminated Z-0362-2022 Bedside PICC CDS Convenience Kit — NaCl 250 mL Bag Inj expired 04/2020 while the kit expiration date was after 04/2020.
2021-10-27 Class II Terminated Z-0361-2022 Venous Access Pack-LF Convenience Kit — NaCl 250 mL Bag Inj expired 04/2020 while the kit expiration date was after 04/2020.
2021-10-27 Class II Terminated Z-0360-2022 Major Vascular CDS Convenience Kit — NaCl 250 mL Bag Inj expired 04/2020 while the kit expiration date was after 04/2020.
2021-10-27 Class II Terminated Z-0359-2022 Neuro Convenience Kit — NaCl 250 mL Bag Inj expired 04/2020 while the kit expiration date was after 04/2020.
2021-10-27 Class II Terminated Z-0358-2022 EVLP Convenience Pack/Kit — NaCl 250 mL Bag Inj expired 04/2020 while the kit expiration date was after 04/2020.
2021-08-06 Class II Terminated Z-2575-2021 NAMIC Stopcocks: (1) NAMIC STOPCOCK, 200 psi (14 bar), REF 70015002, UPN H965700150021, Three-way Stopcock with Rotat… — Potential for sterile barrier breach. Microscopic pinholes within the sterile pouch could potentially lead to non-sterile conditions.
2021-08-06 Class II Terminated Z-2574-2021 NAMIC Manifolds. (1) NAMIC Angiographic MANIFOLD, Medium Pressure, REF 64038301, UPN H965640383011, 3 Valve Manifo… — Potential for sterile barrier breach. Microscopic pinholes within the sterile pouch could potentially lead to non-sterile conditions.
2021-07-01 Class II Terminated Z-2234-2021 Medline Arthroscopy Kit, convenience kit, REF DYNJ904304B, containing expired component NaCl 3000mL Irrigation Bag (exp… — The kits may contain an expired component.
2021-07-01 Class II Terminated Z-2233-2021 Medline Total Knee, convenience kit, REF DYNJ907129B, containing expired component NaCl 3000mL Irrigation Bag (exp. dat… — The kits may contain an expired component.
2021-07-01 Class II Terminated Z-2232-2021 Medline Knee Arthroscopy Kit, convenience kit, REF DYNJ902838C, containing expired component NaCl 3000mL Irrigation Bag… — The kits may contain an expired component.
2021-07-01 Class II Terminated Z-2231-2021 Medline Shoulder CDS convenience kits, REF DYNJ902837D and REF DYNJ902837F, containing expired component NaCl 3000mL Irr… — The kits may contain an expired component.
2021-05-25 Class II Terminated Z-2080-2021 Cotton Rounds/Pads under the following brand names: 1. BEAUTY 360 Extra Large Premium Cotton Ovals - two textures soft… — Potential for mold contamination (Aspergillus vadensis)
2021-04-30 Class II Ongoing Z-1841-2021 Medline Tissue Recovery Instrument Set, Reorder #DYNJ64347A, packaged 3/case, Sterile, Rx. Convenience kit used to r… — The devices may not meet the minimum required sterility assurance level.
2021-03-15 Class II Ongoing Z-1407-2021 Diluent, Stat-Site B-HB, 6x 3ML - Product Usage: Intended to be used with the Stat-Site test strips or KetoSite test car… — Possible false negative or false positive results due to the product being compromised during shipment.
2021-01-25 Class II Terminated Z-1249-2021 RNA MEDICAL, QCHGB HEMOGLOBIN CONTROL, MULTI, REF QC HGB - Product Usage: monitoring the performance of Hemocue Hemoglob… — Product was compromised during shipment.
2021-01-15 Class III Terminated Z-1135-2021 S-O303000 CONTROL, STAT-SITE B-HB, 2X3ML,1LOW,1HIGH - Product Usage: intended for the quantitative determination of the … — Medline Industries, Inc. is removing specific lots of STAT-Site¿ Controls (Low and High) S-O303000, from the market, due to the product being compromised durin…
2020-11-13 Class II Terminated Z-0783-2021 Cardiac Pack - LF, Model DYNJ31903I - Product Usage: This is a type of convenience kit used in various surgeries includi… — The cylindrical sponge component is not x-ray detectable.
2020-11-13 Class II Terminated Z-0782-2021 Greffe Aorte-LF (product info is in French); Model DYNJ31877F - Product Usage: This is a type of convenience kit used in… — The cylindrical sponge component is not x-ray detectable.
2020-11-13 Class II Terminated Z-0781-2021 Thyroid Pack CKHA-LF, Model DYNJ50352B - Product Usage: This is a type of convenience kit used in various surgeries incl… — The cylindrical sponge component is not x-ray detectable.
2020-11-13 Class II Terminated Z-0780-2021 Simple Neck Dissection, Model DYNJ47481C - Product Usage: This is a type of convenience kit used in various surgeries in… — The cylindrical sponge component is not x-ray detectable.
2020-11-13 Class II Terminated Z-0779-2021 Resect. Intest. Laparo-LF, Model DYNJ42667A - Product Usage: This is a type of convenience kit used in various surgeries… — The cylindrical sponge component is not x-ray detectable.
2020-11-05 Class II Terminated Z-0615-2021 RevMedX Trauma Dressings are packaged in a Tyvek Peel pouch, 1 Trauma Dressing per Tyvec Peel Pouch, 30 Pouches per Case… — RevMedX Trauma Dressing is being recalled due to package seal integrity.
2020-10-01 Class II Terminated Z-0297-2021 The Quidel Triage BNP Calibrators — Product compromised during shipment.
2020-09-15 Class II Ongoing Z-0055-2021 Quick Release Gait Belt, 60 — The buckle on the Gait Belt may break due to degradation of the material due to exposure to gamma radiation.
2020-09-14 Class II Terminated Z-0068-2021 Kit Model #65193091, MTO Left Heart Kit - Product Usage: NAMIC Cath Lab and Interventional Radiology (IR) Kits consist o… — Non-sterile kits intended to be sterilized prior to use were sold to accounts without sterilization capabilities.
2020-09-14 Class II Terminated Z-0067-2021 Kit Model #65220955, MTO Left Heart Kit VA Med San Francisco - Product Usage: NAMIC Cath Lab and Interventional Radiolog… — Non-sterile kits intended to be sterilized prior to use were sold to accounts without sterilization capabilities.
2020-09-14 Class II Terminated Z-0066-2021 Kit Model #650600111, MTO Left Heart St Francis Hosp - PG - Product Usage: NAMIC Cath Lab and Interventional Radiology (… — Non-sterile kits intended to be sterilized prior to use were sold to accounts without sterilization capabilities.
2020-09-14 Class II Terminated Z-0065-2021 Kit Model #650305414, MTO Left Heart with DT Boulder Com Hosp - Product Usage: NAMIC Cath Lab and Interventional Radiolo… — Non-sterile kits intended to be sterilized prior to use were sold to accounts without sterilization capabilities.
2020-09-14 Class II Terminated Z-0064-2021 Kit Model #650304917, MTO Protection Station Plus with Drape - Product Usage: NAMIC Cath Lab and Interventional Radiolog… — Non-sterile kits intended to be sterilized prior to use were sold to accounts without sterilization capabilities.
2020-09-14 Class II Terminated Z-0063-2021 Kit Model #650301023, MTO Radiology Kit Cleveland Clinic - Product Usage: NAMIC Cath Lab and Interventional Radiology (I… — Non-sterile kits intended to be sterilized prior to use were sold to accounts without sterilization capabilities.
2020-09-14 Class II Terminated Z-0062-2021 Kit Model #650301018, MTO Vascular Surgery - Cleveland Clinic PG - Product Usage: NAMIC Cath Lab and Interventional Radi… — Non-sterile kits intended to be sterilized prior to use were sold to accounts without sterilization capabilities.
2020-09-14 Class II Terminated Z-0061-2021 Kit Model #65021652, MTO Left Heart Kit United Reg Health - Product Usage: NAMIC Cath Lab and Interventional Radiology (… — Non-sterile kits intended to be sterilized prior to use were sold to accounts without sterilization capabilities.
2020-09-01 Class II Terminated Z-0058-2021 ClearPro Closed Suction Catheter, Model DYNCPDS14T, 14 Fr FOR ENDOTRACHEAL TUBE - Product Usage: Catheters are intended… — There have been reports of the suction catheter coming apart from the device assembly during use.
2020-08-12 Class II Terminated Z-3013-2020 Central Line Dressing Change Tray — Potential of incomplete seals impacting the sterility of the kit.
2020-07-28 Class II Terminated Z-3054-2020 Control, Calibrator Verified, Triage BNP, Model ALR88755 — Product was shipped with refrigeration (ice) instead of frozen (dry ice).
2020-07-09 Class II Terminated Z-2766-2020 Endoscopic Cleaning Brush - Product Usage: Endoscopic cleaning brushes are single use devices intended to clean the inte… — Potential risk of brush detachment during cleaning.
2020-06-30 Class II Ongoing Z-2725-2020 ClearPro Trach T-Piece Closed Suction Catheter, Model DYNCPTP14T, 14 Fr 12.5 IN FOR TRACHEOSTOMY TUBE - Product Usage: C… — There are reports of the suction catheter coming apart from the device assembly during use.
2020-06-30 Class II Ongoing Z-2724-2020 ClearPro T-Piece Closed Suction Catheter, Model DYNCPTP14, 14 Fr 21.3 IN FOR ENDOTRACHEAL TUBE - Product Usage: Catheter… — There are reports of the suction catheter coming apart from the device assembly during use.
2020-03-09 Class II Terminated Z-2040-2020 Custom convenience kits containing Medline brand Sterile Pre-Saturated Povidone Iodine Sponge Products, labeled as follo… — Medline identified that there may be a potential for voids in the packaging seal and loss of sterility on the outside of the foil pouch.
2020-02-10 Class II Terminated Z-1546-2020 Medline Sterile 3mL Syringes with 21GA x 1 Inch Needle 80 each REF DYND3ML21G1A lot 18JBH655 (01) 1088438982153. — Voids were discovered in the packaging seal and loss of sterility on the outside of the contents within the Tyvek Form-Fill-Seal packaging.
2020-02-10 Class II Terminated Z-1545-2020 Medline Winged Sponges Presaturated W/PVP REF DYND70289 DYND70289H Expiration 06/30/2022. — Voids were discovered in the packaging seal and loss of sterility on the outside of the contents within the Tyvek Form-Fill-Seal packaging.
2020-02-10 Class II Terminated Z-1544-2020 Medline Stick Sponge Presaturated W/PVP REF DYND70288 DYND70288H 2/PK Expiration 06/30/2022. — Voids were discovered in the packaging seal and loss of sterility on the outside of the contents within the Tyvek Form-Fill-Seal packaging.
2020-01-21 Class II Terminated Z-1358-2020 Medline ROBOTIC-LF REF CDS984543B Lot 20AKA927 Expiration 2020-09-30 GTIN (01)10888277056350 — The sterile pack inside the Complete Delivery System (CDS) did not go through a complete sterilization cycle, therefore the sterility of these components cannot…
2020-01-21 Class II Terminated Z-1357-2020 Medline HOI LUMBAR REF DYNJ902823G Lot 20AKA895 Expiration 2021-05-31 1 each GTIN (01)10193489219180 — The sterile pack inside the Complete Delivery System (CDS) did not go through a complete sterilization cycle, therefore the sterility of these components cannot…
2020-01-07 Class II Terminated Z-0865-2020 Medline DYNDA1928 VP TRAY WITH PVP Packaged in Mexico GLOVE:Made in Malaysia APPLICATOR:Made in China STERILE (01)… — There is potential for the sterile wrap to become loose while in transit and compromise the sterile barrier.
Filings

All 510(k) clearances (35)

Date K-number Device Code Class Specialty
2024-03-27 DEN210049 Medline ART Skin Harvesting System QYK Class II General, Plastic Surgery
2023-10-26 K230559 Hudson RCI® Disposable Humidifier with 4 PSI Pressure Relief Valve (3230), Hudson RCI® Disposable Humidifier with 6 PSI Pressure Relief Valve (3260) BTT Class II Anesthesiology
2023-06-27 K223100 Hudson RCI AquaTherm III Plus External Adjustable Electronic Heater (050-14) CAF — —
2023-01-25 K222665 Medline UNITE® Ankle Fusion Plating System HRS Class II Orthopedic
2022-12-09 K213054 Medline Sure-Snap Safety Needle, Medline Sure-Snap Safety Syringe FMF — —
2022-11-18 K212911 Konig Mogen Clamp HFX — —
2022-10-25 K220565 Hudson RCI Triflo II Incentive Deep Breathing Exerciser BWF Class II Anesthesiology
2022-05-24 K213481 Medline General Surgery Tray LRO — —
2022-01-14 K212093 Medline Universal Grounding Pad GEI Class II General, Plastic Surgery
2022-01-03 K213068 Medline Smoke Evacuation Shroud FYD Class II General, Plastic Surgery
2021-12-10 K211612 Medline UNITE REFLEX Dynamic Discs HTN Class II Orthopedic
2021-12-03 K212258 Medline Cardiovascular Procedure Kit LRO — —
2021-09-20 K211931 Medline Digital Thermometer Non-Lubricated Probe Sheath FLL Class II General Hospital
2021-08-02 K203538 SensiCare PI Ortho LT Surgical Glove (Tested for Use with Chemotherapy Drugs) KGO — —
2021-07-22 K211944 Medline UNITE® Digital Fusion Screw System HWC Class II Orthopedic
2021-05-04 K203135 Medline Vacu-line Suction Aspirator BTA — —
2021-04-22 K210482 Medline UNITE REFLEX Nitinol Staple System JDR Class II Orthopedic
2021-04-02 K202447 Medline Orbis Surgical Gown FYA Class II General, Plastic Surgery
2021-03-12 K210526 Medline Cautery Tip Cleaner GEI Class II General, Plastic Surgery
2020-12-19 K202668 Signature Latex and Signature Latex Micro, Powder-Free, Surgical Glove, Tested for Use with Chemotherapy Drugs with a Protein Content Label Claim of <50µg/dm2 per Glove of Extractable Protein KGO — —
2020-11-18 K202449 Signature Latex LT, Powder-Free, Surgical Glove, Tested for Use with Chemotherapy Drugs with a Protein Content Label Claim of <50µg/dm² per glove of Extractable Protein KGO — —
2020-10-26 K202179 Medline Glide-On 3G Vinyl Examination Gloves (Tested for use with Chemotherapy Drugs) LYZ — —
2020-10-26 K200150 Medline Powder-Free Orange Nitrile Patient Examination Glove (Tested for use with Fentanyl) LZA — —
2020-10-09 K202285 Medline ENfit OTC Feeding Syringe PNR Class II Gastroenterology, Urology
2020-09-21 K201290 Medline DeNovo 4Pro Electrical Stimulation Device IPF Class II Physical Medicine
2020-09-09 K201829 SensiCare PI Evolution Surgical Glove (Tested for Use with Chemotherapy Drugs) KGO — —
2020-08-04 K193666 Powder-Free Blue Nitrile Examination Gloves (Tested for use with Chemotherapy and Fentanyl) – Regular Cuff; Powder-Free Blue Nitrile Examination Gloves (Tested for use with Chemotherapy Drugs and Fentanyl) - Extended Cuff LZA — —
2020-04-06 K193217 SensiCare PI and SensiCare PI Micro Surgical Gloves KGO — —
2020-04-01 K192988 Dermasure Green Sterile SyntheticPolychloroprene Powder-Free Surgical Glove Tested for Use KGO — —
2020-03-17 K191753 Medline Sterile Powder-Free Nitrile Examination Gloves - Green (Tested For Use with Chemotherapy Drugs) LZA — —
2020-03-06 K191915 SensiCare Sterile Power-Free Polymer Coated Polyisoprene Sugical Glove, Coated with Aloe V KGO — —
2020-02-28 K192820 SensiCare Neoprene Synthetic Polychloroprene Surgical Glove (Tested for Use with Chemotherapy Drugs) KGO — —
2020-01-24 K192641 Gemini Titan Sterilization Wrap FRG Class II General Hospital
2020-01-21 K192985 Medline Glide-On 3G Vinyl Examination Gloves LYZ — —
2020-01-10 K192315 Medline Green Ambidextrous Power-Free Nitrile Examination Gloves with Colloidal Oatmeal USP (Tested for Use with Chemotherapy Drugs) LZA — —
Data source: openFDA · Generated 2026-08-26 09:36 · Last ingest 2026-08-26T13:35:45.365163 · Pipeline: Chrysalis Intelligence