Chrysalis Intelligence · Sponsors · Deroyal Industries, Inc.

Deroyal Industries, Inc.

Powell, TN, US · 7 510(k) clearances · 189 recalls (4 Class I)

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Total clearances
7
2020-01-21 → 2025-11-21
Last 12 months
1
Product codes
5
Most recent
2025-11-21
Trend

Clearance cadence by quarter

Portfolio

Product codes worked

Code Device name Class Specialty Clearances Most recent
OMP Negative Pressure Wound Therapy Powered Suction Pump Class II General, Plastic Surgery 2 2025-11-21
FMT Warmer, Infant Radiant Class II General Hospital 2 2020-04-02
FLL Continuous Measurement Thermometer Class II General Hospital 1 2020-12-23
EYC Catheter, Upper Urinary Tract Class II Gastroenterology, Urology 1 2020-10-15
BZT Stethoscope, Esophageal, With Electrical Conductors Class II Anesthesiology 1 2020-04-02
Safety

Recalls (189)

Class I (serious)
4
Risk of injury / death
Total recalls
189
Currently ongoing
174
Most recent
2026-05-18
DateSeverityStatusRecall # ProductCodeReason
2026-05-18 Class II Ongoing Z-2305-2026 DeRoyal Industries Inc. Ref 46-406, Covaderm Plus, Vascular Access Dressing 6"x6" (15cmx15cm) — Sterile wound dressing, lacks sterility assurance
2025-01-31 Class II Ongoing Z-1291-2025 DeRoyal REF 71-C5100NS Tubing, Suction, Connector; DeRoyal REF 71-C6100NS Tubing, Suction, Connector; DeRoyal REF 71-C… — Due to the inner diameter of the suction tubing connector being smaller than the suction canister lid port connection. This size difference, combined with the d…
2025-01-15 Class II Ongoing Z-1174-2025 DeRoyal AMG Suction Connector Tubing REF: 71-2083, 71-C506, 71-C510, 71-C512, 71-C520, Tubing is intended for fl… — The tubing may not ensure that the yankauer stays intact, and secure to the tubing / yankauer connection for a tight seal. This could result in inadequate sucti…
2024-10-03 Class II Ongoing Z-0309-2025 DeRoyal CHILDREN'S LAPTRACEPACK, 89-9362.06 — DeRoyal is recalling certain lots of surgical procedure pack products that contain a Stryker SafeAir Smoke Evacuation Pencil. The recall is due to Stryker recei…
2024-10-03 Class II Ongoing Z-0308-2025 DeRoyal CHILDREN'S ORTHOPEDIC TRACEPACK, 89-9349-06 — DeRoyal is recalling certain lots of surgical procedure pack products that contain a Stryker SafeAir Smoke Evacuation Pencil. The recall is due to Stryker recei…
2024-10-03 Class II Ongoing Z-0307-2025 DeRoyal CHILDREN'S GENERAL TRACEPACK, REF 89-9342-06 — DeRoyal is recalling certain lots of surgical procedure pack products that contain a Stryker SafeAir Smoke Evacuation Pencil. The recall is due to Stryker recei…
2024-10-03 Class II Ongoing Z-0306-2025 DeRoyal C-SECTION TRACEPACK, REF 89-9338-06 — DeRoyal is recalling certain lots of surgical procedure pack products that contain a Stryker SafeAir Smoke Evacuation Pencil. The recall is due to Stryker recei…
2024-02-13 Class I Ongoing Z-1382-2024 GeoMed Custom Tracecarts, REF Numbers: a) 53-1831 ORTHO TOTAL JOINT TRACECART, b) 53-1836 GENERAL SURGERY TRACECART — DeRoyal manufactured and distributed Surgical Tracecarts that contain a Nurse Assist 16FR Silver Urine Meter Foley which were subsequently recalled.
2023-11-22 Class II Ongoing Z-0622-2024 DeRoyal CARDIAC CATH SET-UP KIT PGYBK, REF 89-10572 — Kit were manufactured and distributed with Edwards Life Sciences TruWave Disposable pressure transducers which were subsequently recalled by Edwards Life Scienc…
2023-09-18 Class II Ongoing Z-0116-2024 DeRoyal Head and Neck procedure kit, REF 89-4473, surgical convenience kit — DeRoyal is recalling certain lots of surgical procedure pack products that contain the B.Braun Medical Norm-Ject 2 Piece Syringe. The recall is due to the poten…
2023-05-30 Class II Ongoing Z-2090-2023 Custom medical procedure packs labeled as: a) CATH ANGIOGRAPHY DRAPE PACK, REF 89-7102; b) CHOLANGIOGRAPHY KIT, RE… — The outer package seal could be open, or compromised which affects the sterility of the procedure pack inside.
2023-05-30 Class II Ongoing Z-2089-2023 Custom medical procedure packs labeled as: a) PELVIC EXAM TRAY, REF 89-6219 — The outer package seal could be open, or compromised which affects the sterility of the procedure pack inside.
2023-05-30 Class II Ongoing Z-2088-2023 Custom medical procedure packs labeled as: a) STANDARD OB PACK ASCENSION WI, REF 89-10640 b) ANGIO PACK, REF 89-1090… — The outer package seal could be open, or compromised which affects the sterility of the procedure pack inside.
2023-05-30 Class II Ongoing Z-2087-2023 Custom medical procedure packs labeled as: a) STURDI STRAINER TRAY STANDARD, REF '89-5014 — The outer package seal could be open, or compromised which affects the sterility of the procedure pack inside.
2023-05-30 Class II Ongoing Z-2086-2023 Custom medical procedure packs labeled as: a) OPEN HEART TRACECART, REF '53-1941; b) CARDIAC CATH PACK, REF '89-… — The outer package seal could be open, or compromised which affects the sterility of the procedure pack inside.
2023-04-17 Class II Ongoing Z-1692-2023 Sterile custom surgical procedure packs (1) 89-10529.04, CNRV OR C-SECTION PACK, New River Valley Medical Center; an… — The custom procedure packs contain light handle covers that have been recalled by another firm.
2023-04-17 Class II Ongoing Z-1691-2023 Sterile custom surgical procedure packs: (1) 89-10507.02, TOTAL KNEE PACK, Stonewall Jackson Hospital; (2) 89-10508.… — The custom procedure packs contain light handle covers that have been recalled by another firm.
2023-02-09 Class II Ongoing Z-1283-2023 DeRoyal SafeLiner Suction Canister, 1000cc, REF PHESL-1000B — The reason for the voluntary recall is due to shrinkage of the canister lid. This shrinkage causes the lid not to contact the outer shell to create a seal and t…
2022-12-12 Class II Completed Z-0927-2023 DeRoyal ORGAN RECOVERY PACK PGYBK, a) REF 89-9004.09 and b) 89-9004.10 — DeRoyal is recalling certain lots of surgical procedure pack products that contain a Medtronic Non-Absorbable Suture. The recall is due to Medtronic determining…
2022-11-28 Class II Terminated Z-0906-2023 DeRoyal Tonsillectomy Tray, REF 89-10698.01 — DeRoyal is recalling certain lots of surgical procedure pack products that contain a ConMed Foot Controlled Electrosurgical Suction Coagulator. The recall is du…
2022-11-03 Class II Ongoing Z-0715-2023 DeRoyal CATARACT PACK, REF 89-10086.05 — DeRoyal procedure packs that contain the affected 3M Health Care Steri Drapes which have been recalled.
2022-11-03 Class II Ongoing Z-0714-2023 DeRoyal CATARACT PACK, REF 89-10040.01 — XXX
2022-11-03 Class II Ongoing Z-0713-2023 DeRoyal CATARACT PACK, REF 89-9241.04 — XXX
2022-11-03 Class II Ongoing Z-0712-2023 DeRoyal CATARACT PACK, REF 89-9241.03 — XXX
2022-11-03 Class II Ongoing Z-0711-2023 DeRoyal CATARACT PACK, REF 89-8859.08 — XXX
2022-11-03 Class II Ongoing Z-0710-2023 DeRoyal CATARACT PACK, REF 89-8650.10 — XXX
2022-11-03 Class II Ongoing Z-0709-2023 GEO-MED CATARACT PACK, REF 89-5790.08 — XXX
2022-11-03 Class II Ongoing Z-0708-2023 DeRoyal TRACECART POSTEROR LAMI MICRODISC TRACECART, REF 53-1960.02 — XXX
2022-11-03 Class II Ongoing Z-0707-2023 DeRoyal TRACECART POSTEROR LUMBAR FUSION TRACECART, REF 53-1961.02 — XXX
2022-11-03 Class II Ongoing Z-0706-2023 DeRoyal TRACECART SHOULDER ARTHROSCOPY TRACECART, REF 53-1962.02 — XXX
2022-11-03 Class II Ongoing Z-0705-2023 DeRoyal BIOPSY PACKPACK, REF 89-9756.05 — XXX
2022-11-03 Class II Ongoing Z-0704-2023 DeRoyal TOTAL KNEE PACK A & B PACK, REF 89-6799.02 — XXX
2022-11-03 Class II Ongoing Z-0703-2023 DeRoyal PACEMAKER ICD PACK, REF 89-10902.01 — XXX
2022-11-03 Class II Ongoing Z-0702-2023 DeRoyal NEURO SPINE BACK PACK PGYBK, REF 89-10853.01 — XXX
2022-11-03 Class II Ongoing Z-0701-2023 DeRoyal SHOULDER ARTHOSCOPY PACK, REF 89-10820.02 — XXX
2022-11-03 Class II Ongoing Z-0700-2023 GEO-MED LOCAL ANESTHESIA PACK, REF 89-10800.01 — XXX
2022-11-03 Class II Ongoing Z-0699-2023 DeRoyal LAMI/CRANI PACK, REF 89-10787.01 — XXX
2022-11-03 Class II Ongoing Z-0698-2023 DeRoyal NEURO PACK, REF 89-10682.02 — XXX
2022-11-03 Class II Ongoing Z-0697-2023 DeRoyal GU PACK, REF 89-10665.03 — XXX
2022-11-03 Class II Ongoing Z-0696-2023 DeRoyal GU PACK, REF 89-10665.02 — XXX
2022-11-03 Class II Ongoing Z-0695-2023 DeRoyal ANTERIOR APPROACH TOTAL HIP A&B PGYBK, REF 89-10612.01 — XXX
2022-11-03 Class II Ongoing Z-0694-2023 DeRoyal LUMBAR DISC PACK, REF 89-10605.02 — XXX
2022-11-03 Class II Ongoing Z-0693-2023 DeRoyal LUMBAR DISC PACK, REF 89-10590.02 — XXX
2022-11-03 Class II Ongoing Z-0692-2023 DeRoyal CMC POSTERIOR SPINE PACK, REF 89-10570.01 — XXX
2022-11-03 Class II Ongoing Z-0691-2023 DeRoyal CARDIAC LINEN PACK, REF 89-10543.02 — XXX
2022-11-03 Class II Ongoing Z-0690-2023 DeRoyal CNRV SPINAL PACK, REF 89-10532.03 — XXX
2022-11-03 Class II Ongoing Z-0689-2023 DeRoyal CNRV PERIPHERAL VAS PACK, REF 89-10530.03 — XXX
2022-11-03 Class II Ongoing Z-0688-2023 DeRoyal PAIN TRAY, REF 89-10464.03 — XXX
2022-11-03 Class II Ongoing Z-0687-2023 DeRoyal PAIN TRAY, REF 89-10464.02 — XXX
2022-11-03 Class II Ongoing Z-0686-2023 DeRoyal HAND PACK, REF 89-10314.03 — XXX
2022-11-03 Class II Ongoing Z-0685-2023 DeRoyal HAND PACK, REF 89-10314.02 — XXX
2022-11-03 Class II Ongoing Z-0684-2023 DeRoyal CRANI PACK, REF 89-10242.04 — DeRoyal procedure packs that contain the affected 3M Health Care Steri Drapes which have been recalled.
2022-11-03 Class II Ongoing Z-0683-2023 DeRoyal CRANI PACK, REF 89-10242.02 — XXX
2022-11-03 Class II Ongoing Z-0682-2023 DeRoyal SHOULDER ARTHOSCOPY PACK, REF 89-10240.03 — XXX
2022-11-03 Class II Ongoing Z-0681-2023 DeRoyal PACEMAKER ICD PACK, REF 89-10216.06 — XXX
2022-11-03 Class II Ongoing Z-0680-2023 DeRoyal PACEMAKER ICD PACK, REF 89-10216.03 — XXX
2022-11-03 Class II Ongoing Z-0679-2023 DeRoyal LUMBAR FUSION PACK, REF 89-10211.05 — XXX
2022-11-03 Class II Ongoing Z-0678-2023 DeRoyal LAMINECTOMY PACK, REF 89-10209.02 — XXX
2022-11-03 Class II Ongoing Z-0677-2023 DeRoyal CRANI PACK, REF 89-10202.05 — XXX
2022-11-03 Class II Ongoing Z-0676-2023 DeRoyal CRANI PACK, REF 89-10202.03 — XXX
2022-11-03 Class II Ongoing Z-0675-2023 DeRoyal NEURO PACK, REF 89-10171.06 — XXX
2022-11-03 Class II Ongoing Z-0674-2023 DeRoyal NEURO PACK, REF 89-10171.05 — XXX
2022-11-03 Class II Ongoing Z-0673-2023 DeRoyal NEURO PACK, REF 89-10171.03 — XXX
2022-11-03 Class II Ongoing Z-0672-2023 DeRoyal TOTAL SHOULDER PACK, REF 89-10151.05 — XXX
2022-11-03 Class II Ongoing Z-0671-2023 DeRoyal SHOULDER ARTHOSCOPY PACK, REF 89-10061.02 — XXX
2022-11-03 Class II Ongoing Z-0670-2023 DeRoyal POSTERIOR LUMBAR FUSION PACK, REF 89-10060.02 — XXX
2022-11-03 Class II Ongoing Z-0669-2023 DeRoyal POSTERIOR LAMI MICRODISC PACK, REF 89-10059.02 — XXX
2022-11-03 Class II Ongoing Z-0668-2023 DeRoyal FACIAL PACK PGYBK, REF 89-10007.03 — XXX
2022-11-03 Class II Ongoing Z-0667-2023 DeRoyal ACDF PACK PGYBK A PACK / B PACK, REF 89-9997.06 — XXX
2022-11-03 Class II Ongoing Z-0666-2023 DeRoyal SHOULDER ARTHOSCOPY PACK, REF 89-9946.04 — XXX
2022-11-03 Class II Ongoing Z-0665-2023 DeRoyal BIOPSY PACK, REF 89-9739.06 — XXX
2022-11-03 Class II Ongoing Z-0664-2023 DeRoyal BIOPSY PACK, REF 89-9739.05 — XXX
2022-11-03 Class II Ongoing Z-0663-2023 DeRoyal BREAST AUGMENTATION PACK, REF 89-9618.05 — XXX
2022-11-03 Class II Ongoing Z-0662-2023 DeRoyal BIOPSY PACK, REF 89-9614.07 — XXX
2022-11-03 Class II Ongoing Z-0661-2023 DeRoyal UNIVERSAL PACK, REF 89-9558.03 — XXX
2022-11-03 Class II Ongoing Z-0660-2023 DeRoyal ABDOMINOPLASTY W/LIPO PACK, REF 89-9557.03 — XXX
2022-11-03 Class II Ongoing Z-0659-2023 DeRoyal LUMBAR/CERVICAL PACK, REF 89-9521.11 — XXX
2022-11-03 Class II Ongoing Z-0658-2023 DeRoyal TOTAL HIP KIT, REF 89-9498.10 — XXX
2022-11-03 Class II Ongoing Z-0657-2023 DeRoyal TOTAL HIP KIT, REF 89-9498.08 — XXX
2022-11-03 Class II Ongoing Z-0656-2023 DeRoyal SHOULDER KIT, REF 89-9497.10 — XXX
2022-11-03 Class II Ongoing Z-0655-2023 DeRoyal SHOULDER KIT, REF 89-9497.08 — XXX
2022-11-03 Class II Ongoing Z-0654-2023 DeRoyal EMERGENT TRAUMA PACK, REF 89-9453.14 — XXX
2022-11-03 Class II Ongoing Z-0653-2023 DeRoyal EMERGENT TRAUMA PACK, REF 89-9453.13 — XXX
2022-11-03 Class II Ongoing Z-0652-2023 DeRoyal EMERGENT TRAUMA PACK, ref 89-9453.12 — XXX
2022-11-03 Class II Ongoing Z-0651-2023 DeRoyal SHOULDER PACK, REF 89-9449.13 — XXX
2022-11-03 Class II Ongoing Z-0650-2023 DeRoyal SHOULDER PACK, REF 89-9449.12 — XXX
2022-11-03 Class II Ongoing Z-0649-2023 DeRoyal ENDOVASCULAR TRACEPACK, REF 89-9350.03 — XXX
2022-11-03 Class II Ongoing Z-0648-2023 DeRoyal MYELOGRAM PACK, REF 89-9304.06 — DeRoyal procedure packs that contain the affected 3M Health Care Steri Drapes which have been recalled.
2022-11-03 Class II Ongoing Z-0647-2023 DeRoyal MYELOGRAM PACK, REF 89-9304.05 — XXX
2022-11-03 Class II Ongoing Z-0646-2023 DeRoyal TOTAL HIP PACK, REF 89-9301.07 — XXX
2022-11-03 Class II Ongoing Z-0645-2023 DeRoyal TOTAL KNEE PACK, REF 89-9300.08 — XXX
2022-11-03 Class II Ongoing Z-0644-2023 DeRoyal BIOPSY PACK, REF 89-9270.05 — XXX
2022-11-03 Class II Ongoing Z-0643-2023 DeRoyal BIOPSY PACK, REF 89-9270.04 — XXX
2022-11-03 Class II Ongoing Z-0642-2023 DeRoyal NEURO PACK, REF 89-9253.09 — XXX
2022-11-03 Class II Ongoing Z-0641-2023 DeRoyal NEURO PACK, REF 89-9253.07 — XXX
2022-11-03 Class II Ongoing Z-0640-2023 DeRoyal FOOT PACK, REF 89-9252.08 — XXX
2022-11-03 Class II Ongoing Z-0639-2023 DeRoyal FOOT PACK, REF 89-9252.07 — XXX
2022-11-03 Class II Ongoing Z-0638-2023 DeRoyal FOOT PACK, REF 89-9252.06 — XXX
2022-11-03 Class II Ongoing Z-0637-2023 DeRoyal MAJOR ORTHO PACK, REF 89-9250.07 — XXX
2022-11-03 Class II Ongoing Z-0636-2023 DeRoyal BASIC EYE PACK, REF 89-9233.08 — XXX
2022-11-03 Class II Ongoing Z-0635-2023 DeRoyal TOTAL HIP PACK, REF 89-9113.07 — XXX
2022-11-03 Class II Ongoing Z-0634-2023 DeRoyal TOTAL HIP PACK, REF 89-9113.06 — XXX
2022-11-03 Class II Ongoing Z-0633-2023 DeRoyal LAMINECTOMY SPINAL FUSION PACK, REF 89-9105.10 — XXX
2022-11-03 Class II Ongoing Z-0632-2023 DeRoyal LAMINECTOMY SPINAL FUSION PACK, REF 89-9105.09 — XXX
2022-11-03 Class II Ongoing Z-0631-2023 DeRoyal LAMINECTOMY SPINAL FUSION PACK, REF 89-9105.08 — XXX
2022-11-03 Class II Ongoing Z-0630-2023 DeRoyal KIT HEART B PACK, REF 89-9042.08 — XXX
2022-11-03 Class II Ongoing Z-0629-2023 DeRoyal KIT HEART B PACK, REF 89-9042.07 — XXX
2022-11-03 Class II Ongoing Z-0628-2023 DeRoyal KIT EXTREMITY PACK, REF 89-8869.09 — XXX
2022-11-03 Class II Ongoing Z-0627-2023 DeRoyal KIT TOTAL HIP, REF 89-8861.07 — DeRoyal procedure packs that contain the affected 3M Health Care Steri Drapes which have been recalled.
2022-11-03 Class II Ongoing Z-0626-2023 DeRoyal TLIF PACK, REF 89-8780.04 — DeRoyal procedure packs that contain the affected 3M Health Care Steri Drapes which have been recalled.
2022-11-03 Class II Ongoing Z-0625-2023 DeRoyal ACDF PACK, REF 89-8779.03 — XXX
2022-11-03 Class II Ongoing Z-0624-2023 DeRoyal SHOULDER ARTHROSCOPY PACK, REF 89-8777.04 — XXX
2022-11-03 Class II Ongoing Z-0623-2023 DeRoyal EYE PACK, REF 89-8756.03 — XXX
2022-11-03 Class II Ongoing Z-0622-2023 GEO-MED BIOPSY TRAY, REF 89-8753.01 — XXX
2022-11-03 Class II Ongoing Z-0621-2023 DeRoyal PORT PACK PGYBK, REF 89-8748.05 — XXX
2022-11-03 Class II Ongoing Z-0620-2023 GEO-MED PODIATRY PACK PGYBK, REF 89-8700.02 — XXX
2022-11-03 Class II Ongoing Z-0619-2023 GEO-MED PODIATRY PACK PGYBK, REF 89-8700.01 — XXX
2022-11-03 Class II Ongoing Z-0618-2023 DeRoyal BASIC PACK, REF 89-8633.07 — XXX
2022-11-03 Class II Ongoing Z-0617-2023 DeRoyal CUSTOM NEURO PACK, REF 89-8392.10 — XXX
2022-11-03 Class II Ongoing Z-0616-2023 DeRoyal CUSTOM NEURO PACK, REF 89-8392.09 — DeRoyal procedure packs that contain the affected 3M Health Care Steri Drapes which have been recalled.
2022-11-03 Class II Ongoing Z-0615-2023 DeRoyal SPINE PACK, REF 89-8361.10 — DeRoyal procedure packs that contain the affected 3M Health Care Steri Drapes which have been recalled.
2022-11-03 Class II Ongoing Z-0614-2023 DeRoyal SPINE PACK, REF 89-8361.09 — DeRoyal procedure packs that contain the affected 3M Health Care Steri Drapes which have been recalled.
2022-11-03 Class II Ongoing Z-0613-2023 DeRoyal SPINE PACK, REF 89-8361.08 — XXX
2022-11-03 Class II Ongoing Z-0612-2023 DeRoyal PODIATRY PACK, REF 89-8359.13 — XXX
2022-11-03 Class II Ongoing Z-0611-2023 DeRoyal PODIATRY PACK, REF 89-8359.10 — XXX
2022-11-03 Class II Ongoing Z-0610-2023 DeRoyal HEART PACK, REF 89-8351.13 — XXX
2022-11-03 Class II Ongoing Z-0609-2023 DeRoyal HEART PACK, REF 89-8351.12 — DeRoyal procedure packs that contain the affected 3M Health Care Steri Drapes which have been recalled.
2022-11-03 Class II Ongoing Z-0608-2023 DeRoyal HEART PACK, REF 89-8351.11 — XXX
2022-11-03 Class II Ongoing Z-0607-2023 DeRoyal BASIC EYE PACK, REF 89-8337.09 — XXX
2022-11-03 Class II Ongoing Z-0606-2023 DeRoyal BASIC EYE PACK, REF 89-8337.08 — XXX
2022-11-03 Class II Ongoing Z-0605-2023 GEO-MED UPPER EXTERMITY PACK, REF 89-8253.02 — XXX
2022-11-03 Class II Ongoing Z-0604-2023 GEO-MED LOWER EXTERMITY PACK, REF 89-8252.02 — DeRoyal procedure packs that contain the affected 3M Health Care Steri Drapes which have been recalled.
2022-11-03 Class II Ongoing Z-0603-2023 DeRoyal EYE TRAY PGYBK, REF 89-7978.02 — DeRoyal procedure packs that contain the affected 3M Health Care Steri Drapes which have been recalled.
2022-11-03 Class II Ongoing Z-0602-2023 DeRoyal ENDOVENOUS PACK, REF 89-7762.05 — DeRoyal procedure packs that contain the affected 3M Health Care Steri Drapes which have been recalled.
2022-11-03 Class II Ongoing Z-0601-2023 DeRoyal ORTHO SPINE BACK PACK, REF 89-7534.09 — XXX
2022-11-03 Class II Ongoing Z-0600-2023 DeRoyal BASIC NEURO PACK, REF 89-7523.16 — XXX
2022-11-03 Class II Ongoing Z-0599-2023 DeRoyal BASIC NEURO PACK, REF 89-7523.15 — XXX
2022-11-03 Class II Ongoing Z-0598-2023 DeRoyal SPINAL FUSION PACK, REF 89-7515.14 — DeRoyal procedure packs that contain the affected 3M Health Care Steri Drapes which have been recalled.
2022-11-03 Class II Ongoing Z-0597-2023 DeRoyal SPINAL FUSION PACK, REF 89-7515.13 — DeRoyal procedure packs that contain the affected 3M Health Care Steri Drapes which have been recalled.
2022-11-03 Class II Ongoing Z-0596-2023 DeRoyal SPINAL FUSION PACK, REF 89-7515.12 — DeRoyal procedure packs that contain the affected 3M Health Care Steri Drapes which have been recalled.
2022-11-03 Class II Ongoing Z-0595-2023 DeRoyal CUSTOM NEURO PACK, REF 89-7353.17 — XXX
2022-11-03 Class II Ongoing Z-0594-2023 DeRoyal RETINAL PACK, REF 89-7336.07 — XXX
2022-11-03 Class II Ongoing Z-0593-2023 DeRoyal VIT RD PACK 86ST, REF 89-7308.09 — XXX
2022-11-03 Class II Ongoing Z-0592-2023 DeRoyal BASIC NEURO PACK, REF 89-7258.13 — DeRoyal procedure packs that contain the affected 3M Health Care Steri Drapes which have been recalled.
2022-11-03 Class II Ongoing Z-0591-2023 DeRoyal BASIC NEURO PACK, REF 89-7258.12 — DeRoyal procedure packs that contain the affected 3M Health Care Steri Drapes which have been recalled.
2022-11-03 Class II Ongoing Z-0590-2023 DeRoyal BASIC NEURO PACK, REF 89-7258.10 — DeRoyal procedure packs that contain the affected 3M Health Care Steri Drapes which have been recalled.
2022-11-03 Class II Ongoing Z-0589-2023 DeRoyal LAPINECTOMY PACK, REF 89-7198.11 — XXX
2022-11-03 Class II Ongoing Z-0588-2023 DeRoyal LAPINECTOMY PACK, REF 89-7198.10 — XXX
2022-11-03 Class II Ongoing Z-0587-2023 DeRoyal TRANS CANAL PACK, REF 89-7157.12 — XXX
2022-11-03 Class II Ongoing Z-0586-2023 DeRoyal CATARACT PACK, REF 89-7135.10 — DeRoyal procedure packs that contain the affected 3M Health Care Steri Drapes which have been recalled.
2022-11-03 Class II Ongoing Z-0585-2023 DeRoyal GU ROBOTIC PACK, REF 89-7063.12 — XXX
2022-11-03 Class II Ongoing Z-0584-2023 DeRoyal LAPAROSCOPIC ROBOTIC TRAY, REF 89-7063.11 — XXX
2022-11-03 Class II Ongoing Z-0583-2023 DeRoyal BREAST TRAY, REF 89-7033.07 — XXX
2022-11-03 Class II Ongoing Z-0582-2023 DeRoyal CANNULTED HIP PACK, REF 89-6977.10 — XXX
2022-11-03 Class II Ongoing Z-0581-2023 DeRoyal CANNULTED HIP PACK CSM, REF 89-6977.09 — DeRoyal procedure packs that contain the affected 3M Health Care Steri Drapes which have been recalled.
2022-11-03 Class II Ongoing Z-0580-2023 DeRoyal CATARACT PACK CSM, REF 89-6863 — DeRoyal procedure packs that contain the affected 3M Health Care Steri Drapes which have been recalled.
2022-11-03 Class II Ongoing Z-0579-2023 DeRoyal SHOULDER PACK, REF 89-6830.13 — XXX
2022-11-03 Class II Ongoing Z-0578-2023 GEO-MED TOTAL KNEE PACK A & B, REF 89-6799.02 — XXX
2022-11-03 Class II Ongoing Z-0577-2023 GEO-MED PLASTIC HAND PACK RF, REF 89-6667.10 — XXX
2022-11-03 Class II Ongoing Z-0576-2023 GEO-MED PLASTIC HAND PACK RF, REF 89-6667.09 — XXX
2022-11-03 Class II Ongoing Z-0575-2023 DeRoyal OPEN SHOULDER PROCEDURE PACK RF, REF 89-6629.09 — DeRoyal procedure packs that contain the affected 3M Health Care Steri Drapes which have been recalled.
2022-11-03 Class II Ongoing Z-0574-2023 DeRoyal OPEN SHOULDER PROCEDURE PACK RF, REF 89-6629.07 — XXX
2022-11-03 Class II Ongoing Z-0573-2023 DeRoyal SHOULDER ARTHORSCOPY PACK RF, REF 89-6628.09 — DeRoyal procedure packs that contain the affected 3M Health Care Steri Drapes which have been recalled.
2022-11-03 Class II Ongoing Z-0572-2023 GEO-MED OPTHALMOLOGY CSTM PCK, REF 89-6387.09 — DeRoyal procedure packs that contain the affected 3M Health Care Steri Drapes which have been recalled.
2022-11-03 Class II Ongoing Z-0571-2023 GEO-MED OPTHALMOLOGY CSTM PCK, REF 89-6387.08 — DeRoyal procedure packs that contain the affected 3M Health Care Steri Drapes which have been recalled.
2022-11-03 Class II Ongoing Z-0570-2023 GEO-MED PODIATRY PACK PGYBK, REF 89-6240.05 — DeRoyal procedure packs that contain the affected 3M Health Care Steri Drapes which have been recalled.
2022-11-03 Class II Ongoing Z-0569-2023 DeRoyal PICC LINE TRAY PGYBK, REF 89-6150.13 — DeRoyal procedure packs that contain the affected 3M Health Care Steri Drapes which have been recalled.
2022-11-03 Class II Ongoing Z-0568-2023 GEO-MED SHOULDER ARTHROSCOPY KNEE PACK, REF 89-5797.09 — DeRoyal procedure packs that contain the affected 3M Health Care Steri Drapes which have been recalled.
2022-11-03 Class II Ongoing Z-0567-2023 GEO-MED TOTAL KNEE PACK A & B PGYK, REF 89-5796.13 — DeRoyal procedure packs that contain the affected 3M Health Care Steri Drapes which have been recalled.
2022-11-03 Class II Ongoing Z-0566-2023 GEO-MED KNEE ARTHROSCOPY PACK, REF 89-5795.07 — DeRoyal procedure packs that contain the affected 3M Health Care Steri Drapes which have been recalled.
2022-11-03 Class II Ongoing Z-0565-2023 DeRoyal PEDI ORTHO PACK, REF 89-5323.20 — DeRoyal procedure packs that contain the affected 3M Health Care Steri Drapes which have been recalled.
2022-11-03 Class II Ongoing Z-0564-2023 DeRoyal EYE TRAY, REF 89-4957.08 — DeRoyal procedure packs that contain the affected 3M Health Care Steri Drapes which have been recalled.
2022-11-03 Class II Ongoing Z-0563-2023 DeRoyal EXTREMITY TRAY PGYBK, REF 89-4081.07 — DeRoyal procedure packs that contain the affected 3M Health Care Steri Drapes which have been recalled.
2022-11-03 Class II Ongoing Z-0562-2023 DeRoyal EYE PACK, REF 89-4051.09 — DeRoyal procedure packs that contain the affected 3M Health Care Steri Drapes which have been recalled.
2022-11-03 Class II Ongoing Z-0561-2023 DeRoyal MAJOR ORAL PACK RF, REF 89-3936.15 — DeRoyal procedure packs that contain the affected 3M Health Care Steri Drapes which have been recalled.
2022-11-03 Class II Ongoing Z-0560-2023 DeRoyal MINOR ORAL / ENT PACK, REF 89-2576.15 — DeRoyal procedure packs that contain the affected 3M Health Care Steri Drapes which have been recalled.
2022-08-12 Class II Terminated Z-1668-2022 DeRoyal Sterile Custom Kits containing ICU Medical MicroClave Clear Connectors — Procedure packs contained a recalled product.
2022-07-15 Class II Terminated Z-1562-2022 DeRoyal limb holders: (1) DeRoyal Limb Holder, Wrist, Fixed, Quick Release, REF M8124; (2) DeRoyal Limb Holder, Ankl… — The webbing strap was laced improperly through the teeth of the buckle allowing the webbing strap to slide and was, therefore, not secure.
2022-03-03 Class II Terminated Z-0880-2022 DeRoyal DEXMED ACCESS CENTER TRAY, containing Prevantics antiseptic (chlorhexidine gluconate and isopropyl alcohol) swab… — A kit component, the PDI Prevantics Swab was recalled due to uncertain validation of test methods used to manufacture the products.
2022-03-03 Class II Terminated Z-0879-2022 DeRoyal Ultra/Mammo Tray, containing Prevantics antiseptic (chlorhexidine gluconate and isopropyl alcohol) swab, for pre… — A kit component, the PDI Prevantics Swab was recalled due to uncertain validation of test methods used to manufacture the products.
2022-03-03 Class II Terminated Z-0878-2022 DeRoyal ST Neonatal Dressing Change Kit, containing Prevantics antiseptic (chlorhexidine gluconate and isopropyl alcohol… — A kit component, the PDI Prevantics Swab was recalled due to uncertain validation of test methods used to manufacture the products.
2021-05-14 Class I Terminated Z-1834-2021 DeRoyal Angio Cath Removal Tray, REF 89-9936.02 — DeRoyal manufactured certain lots of surgical procedure pack products using Hospira Pfizer 1% Lidocaine which was subsequently recalled due to mislabeling; the …
2021-05-14 Class I Terminated Z-1833-2021 DeRoyal Heart Cath Procedure Pack, REF 89-6556.08 — DeRoyal manufactured certain lots of surgical procedure pack products using Hospira Pfizer 1% Lidocaine which was subsequently recalled due to mislabeling; the …
2021-05-14 Class I Terminated Z-1832-2021 DeRoyal Pacemaker Tray Pgybk, REF 89-6360.06 — DeRoyal manufactured certain lots of surgical procedure pack products using Hospira Pfizer 1% Lidocaine which was subsequently recalled due to mislabeling; the …
2021-01-25 Class II Terminated Z-1140-2021 Heart Pack, REF numbers: a) 89-9194.07 b) 89-9194.09 c) 89-9194-10 d) 89-9194-11 Custom surgical procedure pack… — Sternum saw blades within procedure packs are not sterile. The surgical saw blade has a green non-sterile sticker.
2021-01-25 Class II Terminated Z-1139-2021 Open Heart Pack, REF numbers: a) 89-7483.07 b) 89-7483.08 c) 89-7483.09 d) 89-7483.10 Custom surgical procedu… — Sternum saw blades within procedure packs are not sterile. The surgical saw blade has a green non-sterile sticker.
2021-01-25 Class II Terminated Z-1138-2021 CV Basin Set Pack, REF numbers: a) 89-7935.11 b) 89-7935.12 c) 89-7935.13 d) 89-7935.14 e) 89-7935.15 f) 89-7935.… — Sternum saw blades within procedure packs are not sterile. The surgical saw blade has a green non-sterile sticker.
2020-04-24 Class II Terminated Z-1963-2020 DeRoyal Sterile Custom Kits packaged as a Piggy Back with the BD PosiFlush SF Saline Flush Syringe, labeled as follows: … — DeRoyal manufactured procedure packs using BDPosiFlush syringes which were subsequently recalled due holes in the packaging.
2020-02-27 Class II Terminated Z-1604-2020 DeRoyal SECURITY CUFFS, Single Strap, QR Buckle Cuff and Bed, UNIVERSAL, REF M8138 - Product Usage: patient restraint. — One lot of product was inadvertently manufactured with a buckle which does not meet the mechanical hold force required for this device.
Filings

All 510(k) clearances (7)

Date K-number Device Code Class Specialty
2025-11-21 K250586 Prospera Spectruum Negative Pressure Wound Therapy Black Foam Kits and White Foam Accessory OMP Class II General, Plastic Surgery
2024-04-18 K230233 Prospera Spectruum Negative Pressure Wound Therapy System OMP Class II General, Plastic Surgery
2020-12-23 K200631 DeRoyal Temperature Monitoring Probe FLL Class II General Hospital
2020-10-15 K200757 Foley Catheter with Temperature Sensor EYC Class II Gastroenterology, Urology
2020-04-02 K200319 HYDRO-TEMP Neonatal Skin Surface Temperature Sensor, HYDRO-TEMP Neonatal Skin Surface Temperature Sensor with Interface Cable FMT Class II General Hospital
2020-04-02 K193027 Esophageal Stethoscope 9 French, Esophageal Stethoscope 12 French, Esophageal Stethoscope 18 French, Esophageal Stethoscope, 24 French BZT Class II Anesthesiology
2020-01-21 K191425 Hydro-Temp Neonatal Skin Temperature Probe Cover FMT Class II General Hospital
Data source: openFDA · Generated 2026-07-25 22:26 · Last ingest 2026-07-25T13:19:55.737268 · Pipeline: Chrysalis Intelligence