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Browse Device Recalls

8 FDA medical device safety recalls.

FDA Medical Device Recall Enforcement Database

Browse 8 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 8 FDA device recalls.

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DateProductReasonClassFirm
Jun 16, 2022 nordicBrainEX, software versions 2.21 through 2.3.10 When exporting merged results from the BOLD, DSC, and DCE modules of nordicBrainEx, where both th... Class II NordicNeuroLab AS
Aug 20, 2018 fMRI Hardware System VisualSystem allows video signals from the stimulus pr... Complaints of this version of the power supply unit (LPS) (1.0 and 1.1) being dragged into the ma... Class II NordicNeuroLab AS
Oct 28, 2017 fMRI Hardware System - AudioSystem, Version 1.0 The AudioSystem allows aud... Report was of an interrupted MR scan after patient complained about acoustic distortion, and heat... Class II NordicNeuroLab AS
Jul 3, 2015 nordicICE v 2.3.14 nordicICE is an image processing software package to be... The bug causes BOLD activation maps to be visualized as overlays without taking the coregistrati... Class II NordicNeuroLab AS
Dec 15, 2014 nordicTumorEx 1.0 nordicTumorEx is an image processing software package ... An error was discovered in the interpretation of certain DICOM header tags that may lead to incor... Class II NordicNeuroLab AS
Sep 17, 2014 nordicBrainEx 2.0 provides analysis and visualization capabilities of dynamic... An error was discovered in the interpretation of certain DICOM header tags that may lead to incor... Class II NordicNeuroLab AS
Sep 12, 2014 nordicICE 2.3.14 Image processing software package used by trained profess... An error was discovered in the interpretation of certain DICOM header tags that may lead to incor... Class II NordicNeuroLab AS
Dec 21, 2012 nordicBrainEX Product Usage: nordicBrainEx is an image processing softwar... There is an error related to the relative geometry between fiber tracts in a fiber group and imag... Class II NordicNeuroLab AS

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.