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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
Apr 5, 2024 WishFIX Growth Control Plating System, Model Number: TEFCS28-080US. Orthopedi... The products in this lot are incorrectly packed with a Stainless-Steel implant instead of a Titan... Class II Wishbone Medical, Inc.
Jan 4, 2023 WishBone Medical Smart Correction Dual Joint Express Struts, external skeleto... Firm identified that user may be unable to adjust the length of the Smart Correction Dual Joint E... Class II Wishbone Medical, Inc.
Apr 30, 2021 WishBone Medical Plate and Screw System - Screw, Fixation, Bone, Washer, Bolt... Nonconformities were discovered to the engineering specifications for implant plates and screws. Class II Wishbone Medical, Inc.

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.