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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
Jul 25, 2024 NEUROSIGN Disposable Stimulating Dissector, REF 5888-00 Product has have presence of brown discoloration or substance on the hinge area of the device Class II Technomed Europe
Aug 9, 2022 Disposable Subdermal Needle Electrode, Pt/lr, 12 x 0.40mm, product number TE/... Burns of varying degrees can occur to patients with electrodes left in while in the MRI scanner a... Class II Technomed Europe
Dec 8, 2021 Disposable Subdermal Needle Electrode, Corkscrew, Single Use, Sterile; Model ... There is a high risk of the blue hub detaching from the corkscrew needle, resulting the the needl... Class II Technomed Europe

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.