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.
| Date | Product | Reason | Class | Firm |
|---|---|---|---|---|
| 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.