Browse Device Recalls

3,037 FDA medical device safety recalls.

FDA Medical Device Recall Enforcement Database

Browse 3,037 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 3,037 FDA device recalls.

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DateProductReasonClassFirm
Nov 2, 2022 HENRY SCHEIN, Basin Pack, Item No.570-1692 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 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 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, 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 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 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 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 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 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 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 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 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 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 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 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 HENRY SCHEIN, EXTREMITY PACK, Item No.570-2946 Medical and surgical procedure trays and kits underwent certain manufacturing conditions that may... Class II Stradis Medical, LLC dba Stradis Healthcare
Nov 2, 2022 www.StradisHealthcare.com, Endovenous Pack, Item No.682-494, 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, MAJOR EXTREMITY PACK, Item No.570-2783, 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, Surg Pack, Item No.40450SMS, dental 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, Basic Implant Pack, Item No.40561BIP, 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 Surgical room, Implant Pack, Item No.41111UTI, 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, PACEMAKER PACK IItem No.570-2793 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, Labiaplasty PackItem No.570-3118, 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, Phleb, Item No.682-1425, 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, Vas Pack, Item No.888-2520, 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 KIT, Item No.570-1508, general 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 STRADIS HEALTHCARE, CURVED TIP SYRINGE, Item No.60060GCTS, 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, UNIVERSAL TRAY, Item No.570-2787 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, Novasure Pack, Item No.570-1462, general 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, 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 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 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

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.