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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
Mar 26, 2015 EVIS EXERA II Duodenovideoscope OLYMPUS TJF TypeQ180V. This instrument ha... New and validated reprocessing procedures have been issued for the Olympus TJF-Q180V duodenoscope... Class II Olympus America Inc.
Sep 27, 2013 TB-0545PC: THUNDERBEAT 5 mm , 45 em, Pistol Grip TB-0535PC: THUNDERBEAT 5 mm,... Complaints of damage to various models of Thunderbeat Hand Instruments during surgical procedures... Class II Olympus America Inc.
May 20, 2013 Olympus Endoscopic Flushing Pump, Model OPF-2. Facilitates washing of tiss... There is a possibility that the pump head was not shipped in the locked position. If the pump he... Class II Olympus America Inc.
Nov 10, 2009 Olympus SurgMaster UES-40 electrosurgical unit ("UES-40") Product Usage: ... Olympus initiated a software upgrade and enhancement in 2009 and completed the action in 2010. T... Class II Olympus America 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.