Browse Device Recalls

35,307 FDA medical device safety recalls.

FDA Medical Device Recall Enforcement Database

Browse 35,307 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 35,307 FDA device recalls, Class II.

Clear
DateProductReasonClassFirm
Nov 3, 2022 DeRoyal BASIC NEURO PACK, REF 89-7523.16 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 GEO-MED CATARACT PACK, REF 89-5790.08 XXX 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 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 ACDF PACK, REF 89-8779.03 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 BREAST AUGMENTATION PACK, REF 89-9618.05 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 LAMINECTOMY SPINAL FUSION PACK, REF 89-9105.09 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 NEURO SPINE BACK PACK PGYBK, REF 89-10853.01 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 MYELOGRAM PACK, REF 89-9304.05 XXX Class II DeRoyal Industries Inc
Nov 3, 2022 DeRoyal LUMBAR/CERVICAL PACK, REF 89-9521.11 XXX Class II DeRoyal Industries Inc
Nov 3, 2022 DeRoyal VIT RD PACK 86ST, REF 89-7308.09 XXX Class II DeRoyal Industries Inc
Nov 3, 2022 DeRoyal FOOT PACK, REF 89-9252.08 XXX Class II DeRoyal Industries Inc
Nov 3, 2022 DeRoyal PAIN TRAY, REF 89-10464.03 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 CANNULTED HIP PACK, REF 89-6977.10 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 VADER Pedicle System Torque Wrench, Hudson Coupling, 12 Nm, REF 42-702 During internal testing (at manufacturer site) of two torque wrench devices, it was detected that... Class II Icotec Ag
Nov 3, 2022 DeRoyal FACIAL PACK PGYBK, REF 89-10007.03 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 KIT HEART B PACK, REF 89-9042.07 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 SHOULDER PACK, REF 89-9449.13 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 KIT EXTREMITY PACK, REF 89-8869.09 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 RETINAL PACK, REF 89-7336.07 XXX 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 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 DeRoyal LAPAROSCOPIC ROBOTIC TRAY, REF 89-7063.11 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 GEO-MED PLASTIC HAND PACK RF, REF 89-6667.10 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 DeRoyal HAND PACK, REF 89-10314.02 XXX 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 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 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 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 TOTAL KNEE PACK, REF 89-9300.08 XXX 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 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 GEO-MED LOCAL ANESTHESIA PACK, REF 89-10800.01 XXX 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 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 CUSTOM NEURO PACK, REF 89-7353.17 XXX Class II DeRoyal Industries Inc
Nov 3, 2022 DeRoyal EMERGENT TRAUMA PACK, REF 89-9453.14 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.