Browse Device Recalls

2,276 FDA medical device safety recalls.

FDA Medical Device Recall Enforcement Database

Browse 2,276 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 2,276 FDA device recalls in 2022.

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DateProductReasonClassFirm
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 Carefusion V. Mueller SCOVILLE-GREENWOOD BAYONET IRRIGATING BIPOLAR FORCEPS I... 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, Medical Vein, Item No.682-330, Medical and surgical procedure trays and kits underwent certain manufacturing conditions that may... Class II Stradis Medical, LLC dba Stradis Healthcare
Nov 2, 2022 ACE Surgical Supply, 17539 CUSTOM KIT STERILE Item No.003-3880, oral surgery ... 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, Breast, Item No.693-276, 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, BONE MARROW KIT, Item No.570-3092 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 ROUND HANDLE BAYONET BIPOLAR FORCEPS 0.7MM TIP OVERALL ... 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, Varicosity Basic Pack, Item No.682-947, 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, TEMP STIMULATOR SUPPLIES, Item No.570-2883 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
Nov 2, 2022 Carefusion V. Mueller" SEMKIN BIPOLAR FORCEPS WITH STOP, 0.7MM TIP OVERALL LE... 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, OVERALL LENGT... 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, Knee Pack, Item No.570-2908, 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, CATH ANGIO PACK, Item No.570-2930 Medical and surgical procedure trays and kits underwent certain manufacturing conditions that may... Class II Stradis Medical, LLC dba Stradis Healthcare
Nov 2, 2022 Surgical room, SURGICAL PACK, Item No.40996WLS, 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 CareFusion V. Mueller CUSHING MICRO BIPOLAR FORCEPS 0.7MM TIP, OVERALL LENGTH... 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 Small Joint OATS Set, REF AR-8981-06S, 6mm; and Small Joint OATS Set, REF AR-... The devices may be packaged with the wrong reamer size. Class II Arthrex, Inc.
Nov 2, 2022 BASIC IMPLANT PACK, Item No. 40310SBI, 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 Carefusion V. Mueller CUSHING BAYONET BIPOLAR FORCEPS, 0.7MM TIP, INSULATED I... 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 SynCardia Total Artificial Heart System (70CC): 500101-001 SynCardia Total... Due to tears reported tears in the cannula due to wear and tear stress. Class II SynCardia Systems LLC
Nov 2, 2022 HENRY SCHEIN, Amnio Tray, Item No.570-3059, 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, Introducer Kit Micro, Item No.525-038, cardiovascular 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 BIPOLAR FORCEPS 1.5MM TIP, INSULATED OVERALL LE... 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, RHINO PACK, Item No.570-3070 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 ROUND HANDLE BAYONET BIPOLAR FORCEPS 1.5MM TIP OVERALL ... 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 OVE... 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 HARDY BAYONET IRRIGATING BIPOLAR FORCEPS INSULATED, 0.5... 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, Vein Clinics 1, Item No.570-1426 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 SEMKIN BIPOLAR FORCEPS 1.5MM TIP, INSULATED 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 CareFusion V. Mueller ADSON BIPOLAR FORCEPS 1.0MM TIP, INSULATED OVERALL LENG... 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, ENT SET UP PACK, Item No.570-2742 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, Lipo, Item No.681-254, 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, Angio Pack, Item No.686-199, 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, VEIN TRAY, Item No.570-2738, 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, Femoral, Vasc, Item No.686-142, 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, 0.7MM TI... XXX Class II Carefusion 2200 Inc
Nov 2, 2022 STRADIS HEALTHCARE, Vein, Item No.682-577, 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, Blue Tail Custom Pack, Item No.570-3091, 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, Vein & Laser, Item No.682-334R1, 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 Neuro/Spine TITANIUM ROUND HANDLE BAYONET BIPOLAR FORCE... 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, Vein, Item No.682-1732, 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, OMFS, Item No.570-2779, 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, CATH PACK Item No.570-2789 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, Phlebectomy Pack, Item No.682-001, 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 EXTENDED PACK, Item No.570-2890 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 1.0MM WIDE TIP OVERALL LENGTH 7"... 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, Item No.40551TMS. 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 CareFusion V. Mueller TITANIUM ROUND HANDLE BAYONET BIPOLAR FORCEPS 1.5MM 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 STRADIS HEALTHCARE, Endo Pack, Item No.682-509, 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 SCOVILLE-GREENWOOD BAYONET BIPOLAR FORCEPS 1.5MM TIP OV... 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.