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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
Sep 22, 2021 ROSA One 3.1 Brain application The device is intended for the spatial posi... The firm has become aware of a software anomaly affecting ROSA One 3.1 Brain application which le... Class I MEDTECH SAS
Jan 6, 2020 ROSA One 3.1 Brain Application Some cross-sectional images from the image acquisitions of the patients head may not be reconstru... Class II MEDTECH SAS
Jan 6, 2020 ROSA Brain 3.0 Application-Brain Some cross-sectional images from the image acquisitions of the patients head may not be reconstru... Class II MEDTECH SAS
Sep 10, 2019 Rosa Brain 3.0, Model No. ROSA 3.0. The device is delivered assembled in a wo... The instrument holder may be sent on a trajectory that is not within the intended target. If it i... Class I MEDTECH SAS
May 8, 2018 ROSA(TM) Robotized Stereotactic Assistant, Version 2.5 ROSA Surgical Dev... Replacement of units lacking an updated device approval. Class II MEDTECH SAS

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.