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.
| Date | Product | Reason | Class | Firm |
|---|---|---|---|---|
| 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.