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Browse Device Recalls

3 FDA medical device safety recalls.

FDA Medical Device Recall Enforcement Database

Browse 3 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 FDA device recalls.

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DateProductReasonClassFirm
Nov 28, 2023 VADER pedicle system, torque wrench, Catalog Number 42-703 icotec has received notification of one revision that had to be carried out because nut screws ha... Class II Icotec Ag
Nov 28, 2023 VADER pedicle system, torque wrench, Catalog Number 42-702 icotec has received notification of one revision that had to be carried out because nut screws ha... Class II Icotec Ag
Nov 3, 2022 VADER Pedicle System Torque Wrench, Hudson Coupling, 12 Nm, REF 42-702 During internal testing (at manufacturer site) of two torque wrench devices, it was detected that... Class II Icotec Ag

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.