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Browse Device Recalls

5 FDA medical device safety recalls.

FDA Medical Device Recall Enforcement Database

Browse 5 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 5 FDA device recalls.

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DateProductReasonClassFirm
Dec 10, 2025 Mazor X robotic guidance system REF: TPL0059 Software errors that can result in incorrect surgical instrument positioning during spinal surgery. Class II Mazor Robotics Ltd
Jul 17, 2024 Mazor X. Model Number REF TPL0059; stereotaxic orthopedic instrument Software anomalies which can result in two separate issues: A lagging screen display during a nav... Class II Mazor Robotics Ltd
Sep 5, 2023 MAZOR X robotic guidance system, Model TPL0059, with software versions 4.2.2 ... Software update Class II Mazor Robotics Ltd
Jul 2, 2019 Snapshot Tracker Kit, Mas2659-01, KIT0898, Rx Only, Non Sterile, UDI: 0729010... The firm has become aware that the Snapshot Trackers were not manufactured in accordance with sp... Class II Mazor Robotics Ltd
Nov 26, 2014 Carousel MAS1025-01, part of the Brain Surgical Accessories Intra-operative K... In some situations the carousel position pin (locker) may cause the carousel upper plate to pop o... Class II Mazor Robotics Ltd

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.