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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
Jan 11, 2016 Leica Microsystems (Schweiz) Ag. The common name of the device is surgical mi... An electronic component of the Leica M525 OH4 and Leica M720 OH5 surgical microscopes with 400W i... Class II Leica Microsystems, Inc.
Dec 18, 2012 Surgical microscope The device is used to improve the visibility of object... The brake in the Z axis and/or brakes in the AB and C axes failed during installation. Class II Leica Microsystems (Schweiz) Ag
Dec 18, 2012 Surgical microscope The device is used to improve the visibility of object... The brake in the Z axis and/or brakes in the AB and C axes failed during installation. Class II Leica Microsystems (Schweiz) Ag
Jun 4, 2012 Leica M525 F50 Surgical Microscope; Article No. 10338422; Leica Microsystems... Leica Microsystems evaluated data showing that a malfunction resulting in an illumination reducti... Class II Leica Microsystems, 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.