Browse Device Recalls
740 FDA medical device safety recalls.
FDA Medical Device Recall Enforcement Database
Browse 740 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 740 FDA device recalls in TN.
| Date | Product | Reason | Class | Firm |
|---|---|---|---|---|
| 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 |
| Nov 3, 2022 | 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 rec... | Class II | DeRoyal Industries Inc |
| Nov 3, 2022 | DeRoyal HAND PACK, REF 89-10314.02 | XXX | Class II | DeRoyal Industries Inc |
| Nov 3, 2022 | DeRoyal TRACECART POSTEROR LAMI MICRODISC TRACECART, REF 53-1960.02 | XXX | Class II | DeRoyal Industries Inc |
| Nov 3, 2022 | GEO-MED PLASTIC HAND PACK RF, REF 89-6667.10 | XXX | Class II | DeRoyal Industries Inc |
| Nov 3, 2022 | DeRoyal CNRV PERIPHERAL VAS PACK, REF 89-10530.03 | XXX | Class II | DeRoyal Industries Inc |
| Nov 3, 2022 | DeRoyal LAPAROSCOPIC ROBOTIC TRAY, REF 89-7063.11 | XXX | Class II | DeRoyal Industries Inc |
| Nov 3, 2022 | GEO-MED OPTHALMOLOGY CSTM PCK, REF 89-6387.09 | DeRoyal procedure packs that contain the affected 3M Health Care Steri Drapes which have been rec... | Class II | DeRoyal Industries Inc |
| Nov 3, 2022 | GEO-MED PLASTIC HAND PACK RF, REF 89-6667.09 | XXX | Class II | DeRoyal Industries Inc |
| Nov 3, 2022 | DeRoyal RETINAL PACK, REF 89-7336.07 | XXX | Class II | DeRoyal Industries Inc |
| Nov 3, 2022 | DeRoyal SHOULDER ARTHOSCOPY PACK, REF 89-10240.03 | XXX | Class II | DeRoyal Industries Inc |
| Nov 3, 2022 | DeRoyal KIT EXTREMITY PACK, REF 89-8869.09 | XXX | Class II | DeRoyal Industries Inc |
| Nov 3, 2022 | DeRoyal MINOR ORAL / ENT PACK, REF 89-2576.15 | 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 SHOULDER PACK, REF 89-9449.13 | XXX | Class II | DeRoyal Industries Inc |
| Nov 3, 2022 | DeRoyal TRACECART POSTEROR LUMBAR FUSION TRACECART, REF 53-1961.02 | XXX | Class II | DeRoyal Industries Inc |
| Nov 3, 2022 | DeRoyal KIT HEART B PACK, REF 89-9042.07 | XXX | Class II | DeRoyal Industries Inc |
| Nov 3, 2022 | DeRoyal CATARACT PACK CSM, REF 89-6863 | 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 FACIAL PACK PGYBK, REF 89-10007.03 | XXX | Class II | DeRoyal Industries Inc |
| Nov 3, 2022 | DeRoyal TRANS CANAL PACK, REF 89-7157.12 | XXX | Class II | DeRoyal Industries Inc |
| Nov 3, 2022 | DeRoyal CANNULTED HIP PACK, REF 89-6977.10 | XXX | Class II | DeRoyal Industries Inc |
| Nov 3, 2022 | DeRoyal SHOULDER KIT, REF 89-9497.08 | XXX | Class II | DeRoyal Industries Inc |
| Nov 3, 2022 | DeRoyal PAIN TRAY, REF 89-10464.03 | XXX | 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.