Browse Device Recalls
225 FDA medical device safety recalls.
FDA Medical Device Recall Enforcement Database
Browse 225 FDA medical device recall enforcement actions. Each entry includes the device description, reason for recall, classification (Class I through III based on severity), recalling firm, and distribution details. Use the filters below to search by year, classification, state, or keyword.
Medical Device Recalls
Browse 225 FDA device recalls.
| Date | Product | Reason | Class | Firm |
|---|---|---|---|---|
| Nov 3, 2022 | DeRoyal CATARACT PACK, REF 89-8859.08 | XXX | Class II | DeRoyal Industries Inc |
| Nov 3, 2022 | DeRoyal CATARACT PACK, REF 89-8650.10 | XXX | Class II | DeRoyal Industries Inc |
| Nov 3, 2022 | DeRoyal ENDOVASCULAR TRACEPACK, REF 89-9350.03 | XXX | Class II | DeRoyal Industries Inc |
| Nov 3, 2022 | DeRoyal BIOPSY PACK, REF 89-9739.05 | XXX | Class II | DeRoyal Industries Inc |
| Nov 3, 2022 | DeRoyal GU PACK, REF 89-10665.03 | XXX | Class II | DeRoyal Industries Inc |
| Nov 3, 2022 | 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 rec... | Class II | DeRoyal Industries Inc |
| Nov 3, 2022 | DeRoyal TOTAL KNEE PACK A & B PACK, REF 89-6799.02 | XXX | Class II | DeRoyal Industries Inc |
| Nov 3, 2022 | DeRoyal ANTERIOR APPROACH TOTAL HIP A&B PGYBK, REF 89-10612.01 | XXX | Class II | DeRoyal Industries Inc |
| Nov 3, 2022 | DeRoyal CATARACT PACK, REF 89-10040.01 | XXX | Class II | DeRoyal Industries Inc |
| Nov 3, 2022 | GEO-MED BIOPSY TRAY, REF 89-8753.01 | XXX | Class II | DeRoyal Industries Inc |
| Nov 3, 2022 | GEO-MED UPPER EXTERMITY PACK, REF 89-8253.02 | XXX | Class II | DeRoyal Industries Inc |
| Nov 3, 2022 | DeRoyal SHOULDER ARTHOSCOPY PACK, REF 89-9946.04 | XXX | Class II | DeRoyal Industries Inc |
| Nov 3, 2022 | DeRoyal BASIC NEURO PACK, REF 89-7523.15 | XXX | Class II | DeRoyal Industries Inc |
| Nov 3, 2022 | DeRoyal CRANI PACK, REF 89-10242.02 | XXX | Class II | DeRoyal Industries Inc |
| Nov 3, 2022 | DeRoyal HEART PACK, REF 89-8351.12 | DeRoyal procedure packs that contain the affected 3M Health Care Steri Drapes which have been rec... | Class II | DeRoyal Industries Inc |
| Nov 3, 2022 | DeRoyal SPINAL FUSION PACK, REF 89-7515.13 | DeRoyal procedure packs that contain the affected 3M Health Care Steri Drapes which have been rec... | Class II | DeRoyal Industries Inc |
| Nov 3, 2022 | DeRoyal LAMI/CRANI PACK, REF 89-10787.01 | XXX | Class II | DeRoyal Industries Inc |
| Nov 3, 2022 | DeRoyal LUMBAR FUSION PACK, REF 89-10211.05 | XXX | Class II | DeRoyal Industries Inc |
| Nov 3, 2022 | GEO-MED KNEE ARTHROSCOPY PACK, REF 89-5795.07 | DeRoyal procedure packs that contain the affected 3M Health Care Steri Drapes which have been rec... | Class II | DeRoyal Industries Inc |
| Nov 3, 2022 | DeRoyal PORT PACK PGYBK, REF 89-8748.05 | XXX | Class II | DeRoyal Industries Inc |
| Nov 3, 2022 | DeRoyal EMERGENT TRAUMA PACK, REF 89-9453.13 | XXX | Class II | DeRoyal Industries Inc |
| Nov 3, 2022 | DeRoyal LUMBAR DISC PACK, REF 89-10605.02 | XXX | Class II | DeRoyal Industries Inc |
| Nov 3, 2022 | DeRoyal BIOPSY PACKPACK, REF 89-9756.05 | XXX | Class II | DeRoyal Industries Inc |
| Nov 3, 2022 | DeRoyal POSTERIOR LUMBAR FUSION PACK, REF 89-10060.02 | XXX | Class II | DeRoyal Industries Inc |
| Nov 3, 2022 | DeRoyal CATARACT PACK, REF 89-9241.03 | XXX | Class II | DeRoyal Industries Inc |
| Nov 3, 2022 | DeRoyal POSTERIOR LAMI MICRODISC PACK, REF 89-10059.02 | XXX | Class II | DeRoyal Industries Inc |
| Nov 3, 2022 | DeRoyal UNIVERSAL PACK, REF 89-9558.03 | XXX | Class II | DeRoyal Industries Inc |
| Nov 3, 2022 | DeRoyal SPINE PACK, REF 89-8361.09 | DeRoyal procedure packs that contain the affected 3M Health Care Steri Drapes which have been rec... | Class II | DeRoyal Industries Inc |
| Nov 3, 2022 | DeRoyal LUMBAR DISC PACK, REF 89-10590.02 | XXX | Class II | DeRoyal Industries Inc |
| Nov 3, 2022 | DeRoyal CRANI PACK, REF 89-10202.05 | XXX | Class II | DeRoyal Industries Inc |
| Nov 3, 2022 | DeRoyal KIT TOTAL HIP, REF 89-8861.07 | DeRoyal procedure packs that contain the affected 3M Health Care Steri Drapes which have been rec... | Class II | DeRoyal Industries Inc |
| Nov 3, 2022 | DeRoyal SPINE PACK, REF 89-8361.08 | XXX | Class II | DeRoyal Industries Inc |
| Nov 3, 2022 | DeRoyal PACEMAKER ICD PACK, REF 89-10902.01 | XXX | Class II | DeRoyal Industries Inc |
| Nov 3, 2022 | DeRoyal TOTAL HIP PACK, REF 89-9113.07 | XXX | Class II | DeRoyal Industries Inc |
| Nov 3, 2022 | DeRoyal TOTAL HIP PACK, REF 89-9113.06 | XXX | Class II | DeRoyal Industries Inc |
| Nov 3, 2022 | DeRoyal LAPINECTOMY PACK, REF 89-7198.11 | XXX | Class II | DeRoyal Industries Inc |
| Nov 3, 2022 | DeRoyal CRANI PACK, REF 89-10202.03 | XXX | Class II | DeRoyal Industries Inc |
| Nov 3, 2022 | DeRoyal CATARACT PACK, REF 89-9241.04 | XXX | Class II | DeRoyal Industries Inc |
| Nov 3, 2022 | DeRoyal LAMINECTOMY SPINAL FUSION PACK, REF 89-9105.08 | XXX | Class II | DeRoyal Industries Inc |
| Nov 3, 2022 | DeRoyal EMERGENT TRAUMA PACK, REF 89-9453.14 | XXX | Class II | DeRoyal Industries Inc |
| Nov 3, 2022 | DeRoyal CUSTOM NEURO PACK, REF 89-7353.17 | XXX | Class II | DeRoyal Industries Inc |
| Nov 3, 2022 | DeRoyal SPINAL FUSION PACK, REF 89-7515.12 | DeRoyal procedure packs that contain the affected 3M Health Care Steri Drapes which have been rec... | Class II | DeRoyal Industries Inc |
| Nov 3, 2022 | DeRoyal EYE TRAY, REF 89-4957.08 | DeRoyal procedure packs that contain the affected 3M Health Care Steri Drapes which have been rec... | Class II | DeRoyal Industries Inc |
| Nov 3, 2022 | GEO-MED LOCAL ANESTHESIA PACK, REF 89-10800.01 | XXX | Class II | DeRoyal Industries Inc |
| Nov 3, 2022 | DeRoyal MAJOR ORAL PACK RF, REF 89-3936.15 | DeRoyal procedure packs that contain the affected 3M Health Care Steri Drapes which have been rec... | Class II | DeRoyal Industries Inc |
| Nov 3, 2022 | DeRoyal TRACECART SHOULDER ARTHROSCOPY TRACECART, REF 53-1962.02 | XXX | Class II | DeRoyal Industries Inc |
| Nov 3, 2022 | DeRoyal TOTAL KNEE PACK, REF 89-9300.08 | XXX | Class II | DeRoyal Industries Inc |
| Nov 3, 2022 | DeRoyal BASIC NEURO PACK, REF 89-7258.10 | DeRoyal procedure packs that contain the affected 3M Health Care Steri Drapes which have been rec... | Class II | DeRoyal Industries Inc |
| Nov 3, 2022 | DeRoyal PEDI ORTHO PACK, REF 89-5323.20 | DeRoyal procedure packs that contain the affected 3M Health Care Steri Drapes which have been rec... | Class II | DeRoyal Industries Inc |
| Nov 3, 2022 | DeRoyal MYELOGRAM PACK, REF 89-9304.06 | DeRoyal procedure packs that contain the affected 3M Health Care Steri Drapes which have been rec... | Class II | DeRoyal Industries Inc |
Frequently Asked Questions
When a device safety issue is identified, the manufacturer or FDA initiates a recall. The FDA publishes an enforcement report detailing the device, the reason for the recall, and distribution. Healthcare facilities and providers are notified to check their inventory and take corrective action.
All types — from simple devices like blood glucose test strips and surgical gloves to complex devices like pacemakers, defibrillators, insulin pumps, hip implants, and ventilators. Software-driven devices are increasingly common in recalls due to bugs and cybersecurity vulnerabilities.
Use the search and filter tools on this page. Each recall entry includes the device description, model numbers, and distribution details so you can determine if your device is affected. Contact your healthcare provider if you find a match.