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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.

Clear
DateProductReasonClassFirm
Apr 22, 2022 Surgical Suture Kit There is uncertainty about the integrity of the methods used to ensure the sterile barrier integr... Class II 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
Apr 20, 2015 Abdominal Pack and Abdom Pack - contains Devon Light Glove Used during surgery Convenience kits being recalled due to the recall by the manufacturer (Medtronic) of a component ... Class II Stradis Healthcare, LLC.
Apr 20, 2015 Eye Pack - contains Devon Light Glove Used during surgery Convenience kits being recalled due to the recall by the manufacturer (Medtronic) of a component ... Class II Stradis Healthcare, LLC.
Apr 20, 2015 Orthopedic Split Drape Pack - contains Devon Light Glove Used during surgery Convenience kits being recalled due to the recall by the manufacturer (Medtronic) of a component ... Class II Stradis Healthcare, LLC.
Apr 20, 2015 Neurosurgery Pack - contains Devon Light Glove Used during surgery Convenience kits being recalled due to the recall by the manufacturer (Medtronic) of a component ... Class II Stradis Healthcare, LLC.
Apr 20, 2015 Bariatric Pack - contains Devon Light Glove Used during surgery Convenience kits being recalled due to the recall by the manufacturer (Medtronic) of a component ... Class II Stradis Healthcare, LLC.
Apr 20, 2015 Set Up Pack - contains Devon Light Glove Used during surgery Convenience kits being recalled due to the recall by the manufacturer (Medtronic) of a component ... Class II Stradis Healthcare, LLC.
Apr 20, 2015 Gyn Pack - contains Devon Light Glove Used during surgery Convenience kits being recalled due to the recall by the manufacturer (Medtronic) of a component ... Class II Stradis Healthcare, LLC.
Apr 20, 2015 Breast Augmentation Pack and Breast Augmentation Expanded Pack - contains Dev... Convenience kits being recalled due to the recall by the manufacturer (Medtronic) of a component ... Class II Stradis Healthcare, LLC.
Apr 20, 2015 Stradi 4500 - contains Devon Light Glove Used during surgery Convenience kits being recalled due to the recall by the manufacturer (Medtronic) of a component ... Class II Stradis Healthcare, LLC.
Apr 20, 2015 Face Lift Pack - contains Devon Light Glove Used during surgery Convenience kits being recalled due to the recall by the manufacturer (Medtronic) of a component ... Class II Stradis Healthcare, LLC.
Apr 20, 2015 ACL Pack - contains Devon Light Glove Used during surgery Convenience kits being recalled due to the recall by the manufacturer (Medtronic) of a component ... Class II Stradis Healthcare, LLC.
Apr 20, 2015 Laser Evlt Pack and Laser One Leg Evlt - contains Devon Light Glove Used dur... Convenience kits being recalled due to the recall by the manufacturer (Medtronic) of a component ... Class II Stradis Healthcare, LLC.
Apr 20, 2015 Basic Pack - contains Devon Light Glove Used during surgery Convenience kits being recalled due to the recall by the manufacturer (Medtronic) of a component ... Class II Stradis Healthcare, LLC.
Apr 20, 2015 Breast Pack - contains Devon Light Glove Used during surgery Convenience kits being recalled due to the recall by the manufacturer (Medtronic) of a component ... Class II Stradis Healthcare, LLC.
Apr 20, 2015 Minor Pack and Minor Pack II Pack - contains Devon Light Glove Used during s... Convenience kits being recalled due to the recall by the manufacturer (Medtronic) of a component ... Class II Stradis Healthcare, LLC.
Apr 20, 2015 Tummy Tuck Pack - contains Devon Light Glove Used during surgery Convenience kits being recalled due to the recall by the manufacturer (Medtronic) of a component ... Class II Stradis Healthcare, LLC.
Apr 20, 2015 DND Pack - contains Devon Light Glove Used during surgery Convenience kits being recalled due to the recall by the manufacturer (Medtronic) of a component ... Class II Stradis Healthcare, LLC.
Apr 20, 2015 Advanced Vein Care - contains Devon Light Glove Used during surgery Convenience kits being recalled due to the recall by the manufacturer (Medtronic) of a component ... Class II Stradis Healthcare, LLC.
Apr 20, 2015 Open Pack - contains Devon Light Glove Used during surgery Convenience kits being recalled due to the recall by the manufacturer (Medtronic) of a component ... Class II Stradis Healthcare, LLC.
Apr 20, 2015 Upper Extremity Pack - contains Devon Light Glove Used during surgery Convenience kits being recalled due to the recall by the manufacturer (Medtronic) of a component ... Class II Stradis Healthcare, LLC.
Apr 20, 2015 Cysto Pack - contains Devon Light Glove Used during surgery Convenience kits being recalled due to the recall by the manufacturer (Medtronic) of a component ... Class II Stradis Healthcare, LLC.
Apr 20, 2015 Face Neck Pack - contains Devon Light Glove Used during surgery Convenience kits being recalled due to the recall by the manufacturer (Medtronic) of a component ... Class II Stradis Healthcare, LLC.
Apr 20, 2015 Podiatry Pack - contains Devon Light Glove Used during surgery Convenience kits being recalled due to the recall by the manufacturer (Medtronic) of a component ... Class II Stradis Healthcare, LLC.
Apr 20, 2015 Face Lift Pack - contains Devon Light Glove Used during surgery Convenience kits being recalled due to the recall by the manufacturer (Medtronic) of a component ... Class II Stradis Healthcare, LLC.
Apr 20, 2015 Vein Pack, Vein Treatment II Pack, Vein Brunswick Pack, Vein No Lidocaine Pac... Convenience kits being recalled due to the recall by the manufacturer (Medtronic) of a component ... Class II Stradis Healthcare, LLC.
Apr 20, 2015 Hand Pack - contains Devon Light Glove Used during surgery Convenience kits being recalled due to the recall by the manufacturer (Medtronic) of a component ... Class II Stradis Healthcare, LLC.
Apr 20, 2015 Lipo/Buttocks Pack - contains Devon Light Glove Used during surgery Convenience kits being recalled due to the recall by the manufacturer (Medtronic) of a component ... Class II Stradis Healthcare, LLC.
Apr 20, 2015 Plastic Pack and Plastic HNP Pack - contains Devon Light Glove Used during s... Convenience kits being recalled due to the recall by the manufacturer (Medtronic) of a component ... Class II Stradis Healthcare, LLC.
Apr 20, 2015 ENT Pack - contains Devon Light Glove Used during surgery Convenience kits being recalled due to the recall by the manufacturer (Medtronic) of a component ... Class II Stradis Healthcare, LLC.
Apr 20, 2015 Hand Pack - contains Devon Light Glove Used during surgery Convenience kits being recalled due to the recall by the manufacturer (Medtronic) of a component ... Class II Stradis Healthcare, LLC.
Apr 20, 2015 Vein & Vascular Pack - contains Devon Light Glove Used during surgery Convenience kits being recalled due to the recall by the manufacturer (Medtronic) of a component ... Class II Stradis Healthcare, LLC.
Apr 20, 2015 Standard Pack - contains Devon Light Glove Used during surgery Convenience kits being recalled due to the recall by the manufacturer (Medtronic) of a component ... Class II Stradis Healthcare, LLC.
Apr 20, 2015 Lipo Pack, Liposuction Expended Pack, and Liposuction Tray - contains Devon L... Convenience kits being recalled due to the recall by the manufacturer (Medtronic) of a component ... Class II Stradis Healthcare, LLC.
Apr 20, 2015 Vaginal Rejuvenation Pack - contains Devon Light Glove Used during surgery Convenience kits being recalled due to the recall by the manufacturer (Medtronic) of a component ... Class II Stradis Healthcare, LLC.
Apr 20, 2015 Custom Pack - contains Devon Light Glove Used during surgery Convenience kits being recalled due to the recall by the manufacturer (Medtronic) of a component ... Class II Stradis Healthcare, LLC.
Apr 20, 2015 Pediatric Pack - contains Devon Light Glove Used during surgery Convenience kits being recalled due to the recall by the manufacturer (Medtronic) of a component ... Class II Stradis Healthcare, LLC.
Apr 20, 2015 Knee Arthro Pack and Knee Arthro Pack II - contains Devon Light Glove Used d... Convenience kits being recalled due to the recall by the manufacturer (Medtronic) of a component ... Class II Stradis Healthcare, LLC.

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.