Browse Device Recalls

93 FDA medical device safety recalls.

FDA Medical Device Recall Enforcement Database

Browse 93 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 93 FDA device recalls.

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DateProductReasonClassFirm
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
Feb 25, 2022 Lum Lam Custom Pack - Anesthesia Kit The outer bag may be perforated or torn, which may result in a breach in the sterility of the kit. Class II Stradis Medical, LLC dba Stradis Healthcare
Feb 25, 2022 Total Knee Pack - Surgical Kit The outer bag may be perforated or torn, which may result in a breach in the sterility of the kit. Class II Stradis Medical, LLC dba Stradis Healthcare
Feb 25, 2022 Anterior Hip Pack - Surgical Kit The outer bag may be perforated or torn, which may result in a breach in the sterility of the kit. Class II Stradis Medical, LLC dba Stradis Healthcare
Feb 25, 2022 Surgicare Neuro Pack - Neurological Kit The outer bag may be perforated or torn, which may result in a breach in the sterility of the kit. Class II Stradis Medical, LLC dba Stradis Healthcare
Feb 25, 2022 Coryell Memorial Hosp Total, Joint Pack - Surgical Kit The outer bag may be perforated or torn, which may result in a breach in the sterility of the kit. Class II Stradis Medical, LLC dba Stradis Healthcare
Oct 28, 2021 Custom Assemblies, Inc., Single Spike Tumescent Set w/o Chamber, Reorder Numb... This recall has been initiated to address bulk packed, non-sterile Intravascular Administration S... Class II Stradis Medical, LLC dba Stradis Healthcare
Sep 10, 2021 Standard IUD Insertion Kit Firm unable to confirm that the tenaculum devices were produced in accordance with required desig... Class II Stradis Medical, LLC dba Stradis Healthcare
Sep 10, 2021 Endometrial Biopsy Kit Firm unable to confirm that the tenaculum devices were produced in accordance with required desig... Class II Stradis Medical, LLC dba Stradis Healthcare
Sep 10, 2021 Tenaculum, Plastic Firm unable to confirm that the tenaculum devices were produced in accordance with required desig... Class II Stradis Medical, LLC dba Stradis Healthcare
Sep 10, 2021 IUD Insertion Kit Firm unable to confirm that the tenaculum devices were produced in accordance with required desig... Class II Stradis Medical, LLC dba Stradis Healthcare
Sep 10, 2021 IUD Insertion Pack Firm unable to confirm that the tenaculum devices were produced in accordance with required desig... Class II Stradis Medical, LLC dba Stradis Healthcare
Sep 10, 2021 Foundation Kit Firm unable to confirm that the tenaculum devices were produced in accordance with required desig... 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.