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Browse Device Recalls

3 FDA medical device safety recalls.

FDA Medical Device Recall Enforcement Database

Browse 3 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 3 FDA device recalls.

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DateProductReasonClassFirm
Dec 31, 2019 Ulrich medical neon3 OCT spinal stabilization, REF CS 3917-12, Locking screw ... Due to a production error, the weld seam of the "Locking screw for crosslink, screw-to-screw" can... Class II ulrich medical USA Inc
Mar 8, 2019 ULRICH Torque Limiting Handle for use with a Set Screw Driver to perform the ... Certain Torque Limiting Handles in the field are beyond their 3 year calibration life. Class II ulrich medical USA Inc
Mar 7, 2017 uNion Cervical Plate System Product Usage: The uNion Cervical Plate Syste... Surgical technique was revised to prevent static plate screws blocking mechanisms from disassocia... Class II Ulrich Medical USA 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.