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Browse Device Recalls

4 FDA medical device safety recalls.

FDA Medical Device Recall Enforcement Database

Browse 4 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 4 FDA device recalls.

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DateProductReasonClassFirm
Sep 10, 2019 NovaPACS Diagnostic Viewer. NovaPACS is a picture archiving and communication... The firm received a report of an atypical dataset being generated. When using the cross-localizat... Class II Novarad Corporation
Aug 12, 2016 NovaPACS versions 8.4.7, 8.5.3, and 8.5.6. Distributed by Novarad Corporation... Novarad Corporation announces a voluntary field action for the NovaPACS versions 8.4.7, 8.5.3, an... Class II Novarad Corporation
Nov 16, 2015 NovaPACS  Diagnostic Viewer versions 8.3.7, 8.4.2, 8.4.3, and 8.4.4. Novara... The SUV values that are being calculated in the PET/CT fusion tool are incorrect. Class II Novarad Corporation
May 9, 2013 NovaPACS  versions 7.4, 7.5, 7.6, and 8.0, Diagnostic Viewer. Distributed by... Potential for images to be flipped while streaming, which could incorrectly display image orienta... Class II Novarad Corporation

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.