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.

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DateProductReasonClassFirm
Nov 3, 2022 DeRoyal PACEMAKER ICD PACK, REF 89-10216.06 XXX Class II DeRoyal Industries Inc
Nov 3, 2022 DeRoyal PODIATRY PACK, REF 89-8359.10 XXX Class II DeRoyal Industries Inc
Nov 3, 2022 DeRoyal LAMINECTOMY PACK, REF 89-10209.02 XXX Class II DeRoyal Industries Inc
Nov 3, 2022 DeRoyal SHOULDER ARTHORSCOPY PACK RF, REF 89-6628.09 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 FOOT PACK, REF 89-9252.06 XXX Class II DeRoyal Industries Inc
Nov 3, 2022 DeRoyal BIOPSY PACK, REF 89-9270.04 XXX Class II DeRoyal Industries Inc
Nov 3, 2022 DeRoyal CANNULTED HIP PACK CSM, REF 89-6977.09 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 SHOULDER PACK, REF 89-9449.12 XXX Class II DeRoyal Industries Inc
Nov 3, 2022 DeRoyal CARDIAC LINEN PACK, REF 89-10543.02 XXX Class II DeRoyal Industries Inc
Nov 3, 2022 GEO-MED TOTAL KNEE PACK A & B, REF 89-6799.02 XXX Class II DeRoyal Industries Inc
Nov 3, 2022 DeRoyal PICC LINE TRAY PGYBK, REF 89-6150.13 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 PAIN TRAY, REF 89-10464.02 XXX Class II DeRoyal Industries Inc
Nov 3, 2022 DeRoyal HAND PACK, REF 89-10314.03 XXX Class II DeRoyal Industries Inc
Nov 3, 2022 DeRoyal NEURO PACK, REF 89-9253.07 XXX Class II DeRoyal Industries Inc
Nov 3, 2022 DeRoyal LAMINECTOMY SPINAL FUSION PACK, REF 89-9105.10 XXX Class II DeRoyal Industries Inc
Nov 3, 2022 DeRoyal NEURO SPINE BACK PACK PGYBK, REF 89-10853.01 XXX Class II DeRoyal Industries Inc
Nov 3, 2022 DeRoyal FOOT PACK, REF 89-9252.07 XXX Class II DeRoyal Industries Inc
Nov 3, 2022 DeRoyal LAMINECTOMY SPINAL FUSION PACK, REF 89-9105.09 XXX Class II DeRoyal Industries Inc
Nov 3, 2022 DeRoyal PODIATRY PACK, REF 89-8359.13 XXX Class II DeRoyal Industries Inc
Nov 3, 2022 DeRoyal BREAST AUGMENTATION PACK, REF 89-9618.05 XXX Class II DeRoyal Industries Inc
Nov 3, 2022 DeRoyal ORTHO SPINE BACK PACK, REF 89-7534.09 XXX Class II DeRoyal Industries Inc
Nov 3, 2022 DeRoyal ACDF PACK, REF 89-8779.03 XXX Class II DeRoyal Industries Inc
Nov 3, 2022 DeRoyal TLIF PACK, REF 89-8780.04 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 ARTHOSCOPY PACK, REF 89-10820.02 XXX Class II DeRoyal Industries Inc
Nov 3, 2022 GEO-MED CATARACT PACK, REF 89-5790.08 XXX Class II DeRoyal Industries Inc
Nov 3, 2022 DeRoyal ACDF PACK PGYBK A PACK / B PACK, REF 89-9997.06 XXX Class II DeRoyal Industries Inc
Nov 3, 2022 DeRoyal BASIC NEURO PACK, REF 89-7523.16 XXX Class II DeRoyal Industries Inc
Nov 3, 2022 DeRoyal HEART PACK, REF 89-8351.13 XXX Class II DeRoyal Industries Inc
Nov 3, 2022 DeRoyal CNRV SPINAL PACK, REF 89-10532.03 XXX Class II DeRoyal Industries Inc
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

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.