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