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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.

Clear
DateProductReasonClassFirm
Sep 6, 2024 Enterprise Imaging XERO Viewer- software application used for reference and d... Software defect, when an image has non-square pixel spacing, the reference/localizer line is inco... Class II Agfa Healthcare NV
Dec 5, 2022 Agfa HealthCare Enterprise Imaging XERO Viewer There is a software defect that can cause issues with images. Class II Agfa Healthcare NV
Aug 3, 2018 Enterprise Imaging Desktops Enterprise Imaging Desktops (Radiology Suite/C... Adding an additional comparison study to the Clinical Side Bar in the Enterprise Imaging Diagnost... Class II Agfa Healthcare NV

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.