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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
Aug 27, 2014 McKesson Cardiology" Hemo intended for complete physiological/hemodynamic mon... Software Error: The McKesson Cardiology Hemo calculation section incorrectly converts the Hemoglo... Class II Mckesson Information Solutions LLC
Jun 25, 2014 McKesson Cardiology Hemo. McKesson Cardiology" Hemo is intended for comple... McKesson Cardiology Hemo front-end parameter boxes must undergo annual maintenance testing to es... Class II Mckesson Information Solutions LLC
Dec 23, 2013 Horizon Medical Imaging, Picture Archive Communication System (PACS). Images may be archived to an incorrect or invalid archive location resulting in incorrect images ... Class II Mckesson Information Solutions LLC
Oct 15, 2013 McKesson Radiology 12.0, Picture Archiving Communication System (PACSA). When merging two patient records into one patient record using McKesson Radiology 12.0, the resul... Class II Mckesson Information Solutions LLC
Sep 4, 2013 McKesson Horizon Medical Imaging (HMI) Radiological Image Processing System, ... Software malfunction may occur resulting in a certain combination of server configurations which ... Class II Mckesson Information Solutions LLC

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.