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Browse Device Recalls

4 FDA medical device safety recalls.

FDA Medical Device Recall Enforcement Database

Browse 4 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 4 FDA device recalls.

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DateProductReasonClassFirm
Aug 27, 2014 GYRUS ACMI, REF 3345 -Everest BiCOAG MOLly Forceps 5mm/45cm REF 3345PK - PKS... Due to an anomaly in the packaging process, it is possible that a defective seal could be present... Class II Gyrus Medical, Inc
Jul 8, 2014 Gyrus ACMI Falope-Ring Dilator, item 000878-4. The Falope-Ring Dilator is a ... Falope-Ring Dilator for Reusable Falope-Ring Band Applicators have been sold as a stand-alone non... Class II Gyrus Medical, Inc
Feb 19, 2014 Gyrus ACMI Disposable Falope-Ring Band Applicator Kits. REF 006889-901 and R... Due to an anomaly in the packaging process for specific lots of Disposable Falope-Ring Band Kit, ... Class II Gyrus Medical, Inc
Jul 24, 2013 GYRUS ACMI, REF 3740, Everest BiCOAG Bipolar Dissecting Forceps 5mm/45 cm, St... On April 29, 2013 Olympus Surgical Technologies America R&D received results from an accelerated... Class II Gyrus 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.