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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 2, 2016 McKesson Radiology 12.2 - Picture Archive Communication System (PACS) Issue for customers that use an EMR login or legacy web URL login or legacy web URL login for McK... Class II Mckesson Medical Imaging
Jul 12, 2016 McKesson Radiology, versions 12.1.1 and 12.2 McKesson Radiology (MR) is... The STAT priority icon was not displayed in the Study List when the study was opened. Class II Mckesson Medical Imaging Group
May 29, 2012 Horizon Medical Imaging system. Product Usage: Horizon Medical Imaging is... There is a potential to save reports in RadReport with an Incorrect Final Status. Class II Mckesson Medical Imaging Group

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.