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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
Sep 8, 2023 Omega Medical Imaging Elevating Monitor Suspension Systems, Part Number 1000-... An actuator separated from the pivot mechanism on a lower monitor boom system column. The lower b... Class II Omega Medical Imaging, Inc.
Feb 28, 2023 Omega Medical Imaging Elevating Monitor Suspension, Part Number 1000-0085 An actuator separated from the pivot mechanism on a lower monitor boom system column and became d... Class II Omega Medical Imaging, Inc.
Mar 23, 2017 Omega Medical Imaging - 2 over 2 Elevating Monitor Suspension pillar/column a... Elevating Monitor Suspension column dropping and will not rise back up. Class II Omega Medical Imaging, Inc.
Jun 21, 2016 2 over 2 Elevating Monitor Suspension - Omega Medical Imaging, LLC Elevating... Elevating Monitor Suspension separated from the lifting column bracket Class II Omega Medical Imaging, 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.