Browse Device Recalls

164 FDA medical device safety recalls.

FDA Medical Device Recall Enforcement Database

Browse 164 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 164 FDA device recalls.

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DateProductReasonClassFirm
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
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 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 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, 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, 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 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 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
Jul 25, 2022 NARMD MEDICAL DEPOT Scissors Iris Curved 4.5", Part Number ZZ-0697 The sterile barrier may be compromised. Class II Stradis Medical, LLC dba Stradis Healthcare
Jul 25, 2022 NARMD MEDICAL DEPOT Forceps - Kelly Curved 5.5"; Part Number: ZZ-0701 The sterile barrier may be compromised. Class II Stradis Medical, LLC dba Stradis Healthcare
Jul 25, 2022 NARMD MEDICAL DEPOT Forceps - Kelly Straight 5.5"; Part Number: ZZ-0700 The sterile barrier may be compromised. Class II Stradis Medical, LLC dba Stradis Healthcare
May 10, 2022 VYGON DRESSING CHANGE W/MAXISWAB kit, REF AMS-8465CS Potential for incomplete seals. Class II 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.