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.

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DateProductReasonClassFirm
Nov 3, 2022 DeRoyal LAMINECTOMY SPINAL FUSION PACK, REF 89-9105.08 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 CRANI PACK, REF 89-10202.03 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 TOTAL HIP PACK, REF 89-9113.06 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 PACEMAKER ICD PACK, REF 89-10902.01 XXX 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 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 CRANI PACK, REF 89-10202.05 XXX 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 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 UNIVERSAL PACK, REF 89-9558.03 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 CATARACT PACK, REF 89-9241.03 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 BIOPSY PACKPACK, REF 89-9756.05 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 EMERGENT TRAUMA PACK, REF 89-9453.13 XXX 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 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 NEURO PACK, REF 89-9253.07 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 PAIN TRAY, REF 89-10464.02 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 GEO-MED TOTAL KNEE PACK A & B, REF 89-6799.02 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 DeRoyal SHOULDER PACK, REF 89-9449.12 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 2, 2022 STRADIS HEALTHCARE, Vasc Vein, Item No.682-1583, Medical and surgical procedure trays and kits underwent certain manufacturing conditions that may... Class II Stradis Medical, LLC dba Stradis Healthcare
Nov 2, 2022 STRADIS HEALTHCARE, COTTON APPLICATOR 3" Item No.505-010, Medical and surgical procedure trays and kits underwent certain manufacturing conditions that may... Class II Stradis Medical, LLC dba Stradis Healthcare
Nov 2, 2022 HENRY SCHEIN, PROCEDURE TRAY, Item No.570-2900, Medical and surgical procedure trays and kits underwent certain manufacturing conditions that may... Class II Stradis Medical, LLC dba Stradis Healthcare
Nov 2, 2022 CareFusion V. Mueller TITANIUM ROUND HANDLE BAYONET BIPOLAR FORCEPS,1.0MM TIP... BD has determined that the Instructions For Use (IFU) provided by BD is missing certain content t... Class II Carefusion 2200 Inc
Nov 2, 2022 Carefusion V. Mueller GERALD BAYONET BIPOLAR FORCEPS 1.0MM TIP, INSULATED IRR... BD has determined that the Instructions For Use (IFU) provided by BD is missing certain content t... Class II Carefusion 2200 Inc
Nov 2, 2022 CareFusion V. Mueller CUSHING BAYONET BIPOLAR INSULATED FORCEPS, 0.7MM TIP O... BD has determined that the Instructions For Use (IFU) provided by BD is missing certain content t... Class II Carefusion 2200 Inc
Nov 2, 2022 HENRY SCHEIN, Vas Reversal Pack, Item No.888-2549, Medical and surgical procedure trays and kits underwent certain manufacturing conditions that may... Class II Stradis Medical, LLC dba Stradis Healthcare
Nov 2, 2022 Carefusion V. Mueller" CUSHING BAYONET BIPOLAR FORCEPS, 2.0MM TIP, INSULATED ... BD has determined that the Instructions For Use (IFU) provided by BD is missing certain content t... Class II Carefusion 2200 Inc
Nov 2, 2022 STRADIS HEALTHCARE, Angioplasty, Item No.682-1937, Medical and surgical procedure trays and kits underwent certain manufacturing conditions that may... Class II Stradis Medical, LLC dba Stradis Healthcare
Nov 2, 2022 Carefusion V. Mueller"GERALD BIPOLAR FORCEPS INSULATED, 1.0MM TIP OVERALL LEN... BD has determined that the Instructions For Use (IFU) provided by BD is missing certain content t... Class II Carefusion 2200 Inc
Nov 2, 2022 STRADIS HEALTHCARE, Surg Pk, Item No.40714IES, oral surgery tray Medical and surgical procedure trays and kits underwent certain manufacturing conditions that may... Class II Stradis Medical, LLC dba Stradis Healthcare
Nov 2, 2022 HENRY SCHEIN, SINGLE SHOT EPIDURAL, Item No.570-3089 Medical and surgical procedure trays and kits underwent certain manufacturing conditions that may... Class II Stradis Medical, LLC dba Stradis Healthcare
Nov 2, 2022 STRADIS HEALTHCARE, VENOUS ACCESS PACK, Item No.682-1993R1, Medical and surgical procedure trays and kits underwent certain manufacturing conditions that may... Class II Stradis Medical, LLC dba Stradis Healthcare
Nov 2, 2022 HENRY SCHEIN, SURGICAL PAIN TRAY, Item No.570-1482 Medical and surgical procedure trays and kits underwent certain manufacturing conditions that may... Class II Stradis Medical, LLC dba Stradis Healthcare
Nov 2, 2022 Carefusion V. Mueller" HARDY-STYLE BAYONET BIPOLAR FORCEPS, 0.5MM TIP, INSULA... BD has determined that the Instructions For Use (IFU) provided by BD is missing certain content t... Class II Carefusion 2200 Inc
Nov 2, 2022 HENRY SCHEIN, LOOP RECORDER PACK, Item No.570-2891 Medical and surgical procedure trays and kits underwent certain manufacturing conditions that may... Class II Stradis Medical, LLC dba Stradis Healthcare
Nov 2, 2022 CareFusion V. Mueller TITANIUM BAYONET BIPOLAR FORCEPS, 0.5MM TIP, ANGLED-UP ... BD has determined that the Instructions For Use (IFU) provided by BD is missing certain content t... Class II Carefusion 2200 Inc
Nov 2, 2022 STRADIS HEALTHCARE, Surgery PK, Item No.682-1728, Medical and surgical procedure trays and kits underwent certain manufacturing conditions that may... Class II Stradis Medical, LLC dba Stradis Healthcare
Nov 2, 2022 HENRY SCHEIN, Basin Set, Item No.570-1803 Medical and surgical procedure trays and kits underwent certain manufacturing conditions that may... Class II Stradis Medical, LLC dba Stradis Healthcare
Nov 2, 2022 HENRY SCHEIN, BASIC PACK, Item No.570-2719, UDI/DI (case) H65857027191, UDI/D... Medical and surgical procedure trays and kits underwent certain manufacturing conditions that may... Class II Stradis Medical, LLC dba Stradis Healthcare
Nov 2, 2022 CareFusion V. Mueller TITANIUM BAYONET INSULATED IRRIGATING BIPOLAR FORCEPS 1... BD has determined that the Instructions For Use (IFU) provided by BD is missing certain content t... Class II Carefusion 2200 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.