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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.

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DateProductReasonClassFirm
Jul 21, 2015 Neuro Kinetics, Inc. (NKI) I-Portal¿ NOTC system with the OVAR research test;... The devices that included the OVAR research test were not cleared for marketing and mTBI research... Class II Neuro Kinetics, Inc.
Apr 30, 2015 I-Portal¿ NOTC and VNG; a device used to measure, record, or visually display... complaints of system malfunction and unintended, sudden movement at start up. No injuries reported. Class II Neuro Kinetics, Inc.
Nov 21, 2013 Normative Data Template CD for use with the I-Portal devices. Used to meas... The data provided on the Normative Data Template CD for use with the I-Portal devices has not rec... Class II Neuro Kinetics, Inc.

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.