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Browse Device Recalls

2 FDA medical device safety recalls.

FDA Medical Device Recall Enforcement Database

Browse 2 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 2 FDA device recalls.

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DateProductReasonClassFirm
Oct 11, 2021 GM Helix Acqua Implant 3.5x10, Article No. 140.944 3.5x11.5mm implants were mislabeled as 3.5x10mm implants. In borderline cases where the bone qual... Class II Jjgc Industria E Comercio De Materials Dentario...
Dec 23, 2019 Neodent Tapered Guided Surgery Drill, Article No. 103.436. UDI 07899878030041... The laser engraving of the product incorrectly identifies the 4.3 Tapered Guided Surgery Drill as... Class II Jjgc Industria E Comercio De Materials Dentario...

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.