Browse Device Recalls

12 FDA medical device safety recalls.

FDA Medical Device Recall Enforcement Database

Browse 12 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 12 FDA device recalls.

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DateProductReasonClassFirm
Aug 13, 2025 Change Healthcare Radiology Solutions software version 14.2.2 Due to software issue, radiology reports may not be fully displayed when viewing. Class II CHANGE HEALTHCARE CANADA COMPANY
May 22, 2025 Change Healthcare Cardiology Hemo Software Due to complaints, software update may cause software to unexpectedly shutdown. Class II CHANGE HEALTHCARE CANADA COMPANY
May 22, 2025 Change Healthcare Cardiology Hemodynamics Software Due to complaints, software update may cause software to unexpectedly shutdown. Class II CHANGE HEALTHCARE CANADA COMPANY
Aug 21, 2024 McKesson Cardiology Hemo. Versions 13.0, 13.1.1, 13.1.2, 13.2, 13.2.1, 14.0. A potential issue has been identified in Change Healthcare Cardiology Hemo where incorrect data e... Class II CHANGE HEALTHCARE CANADA COMPANY
Aug 21, 2024 Change Healthcare Cardiology Hemo. Versions 14.2, 14.1.1, 14.2, 14.3, 14.3.2... A potential issue has been identified in Change Healthcare Cardiology Hemo where incorrect data e... Class II CHANGE HEALTHCARE CANADA COMPANY
Aug 21, 2024 Horizon Cardiology Hemo. Version 12.2. A potential issue has been identified in Change Healthcare Cardiology Hemo where incorrect data e... Class II CHANGE HEALTHCARE CANADA COMPANY
Nov 1, 2023 Change Healthcare Stratus Imaging PACS 1.4 and Stratus Imaging Share 1.4, a c... Under certain circumstances, information from HL7 messages received by Stratus PACS/Imaging Share... Class II CHANGE HEALTHCARE CANADA COMPANY
Oct 12, 2023 Change Healthcare Radiology Solutions, software versions 14.0, 14.1, and 14.2... Change Healthcare has identified a software issue where Change Healthcare Radiology Solutions 14.... Class II CHANGE HEALTHCARE CANADA COMPANY
Apr 19, 2021 Change Healthcare Enterprise Viewer - Product Usage: intended to be used with... A software defect was identified where the Image Styles defined by presentation states from CHRS ... Class II CHANGE HEALTHCARE CANADA COMPANY
Mar 17, 2021 Change Healthcare Enterprise Viewer Change Healthcare has identified an intermittent software defect which may result in an anchor st... Class II CHANGE HEALTHCARE CANADA COMPANY
Aug 25, 2020 Change Healthcare Radiology Solutions 14.0 Software defect which may potentially result in one or more images missing in a study Class II CHANGE HEALTHCARE CANADA COMPANY
Feb 10, 2020 McKesson Cardiology ECG Management, Change Healthcare Cardiology ECG Management Inaccurate estimation of the heart rate may occur in instances where the user is estimating heart... Class II CHANGE HEALTHCARE CANADA COMPANY

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.