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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
Feb 12, 2016 Universal Clamp¿ System (IFU reference: SNA027-N-90001). Provides the stab... Zimmer Biomet is initiating a Medical Device Correction Notice to provide updated cleaning and di... Class II Zimmer Spine, Inc.
Feb 12, 2016 Instinct¿ Java¿ System (IFU reference: 046WAN0000T) . Stabilizes one or mo... Zimmer Biomet is initiating a Medical Device Correction Notice to provide updated cleaning and di... Class II Zimmer Spine, Inc.
Feb 3, 2016 Virage OCT Spinal Fixation System. Intended to promote fusion of the Occipi... Zimmer Biomet Spine is initiating a Medical Device Correction regarding the Virage OCT Spinal Fix... Class II Zimmer Spine, Inc.
Oct 9, 2013 Trinica Anterior Lumbar Plate (ALP) system, part 07.01058.001. Non Sterile, ... Zimmer Spine, Inc. is initiating a correction regarding the Trinica ALP Instrument Tray, part 07.... Class II Zimmer, 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.