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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
Nov 21, 2016 Mallinckrodt Pharmaceuticals INOmax DSIR Plus delivery system. Model 10007. ... Mallinckrodt discovered that some devices may have been manufactured with an out-of-tolerance man... Class II INO Therapeutics (dba Ikaria)
Jan 14, 2015 Ikaria, INOmax DSIR (Delivery System), Model 10007. Nitric oxide delivery s... Potential delivery failure alarm condition. INOmax DSIR with software version 2.0.4 and a certa... Class II INO Therapeutics (dba Ikaria)
Oct 17, 2014 INOMAX DSIR Nitric Oxide delivery system, Model 10007, software version 3.1.0... An issue has been identified in the INOmax DSIR system that could result in monitored Nitric Oxid... Class II INO Therapeutics (dba Ikaria)
Mar 27, 2014 INOmax DSIR, model 10007, Nitric Oxide Delivery System, with Software version... An anomaly impacts the monitoring system of INOmax DSIR Plus (software 3.0.0). When the integrat... Class II INO Therapeutics (dba Ikaria)

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.