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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
Jan 4, 2016 Ottobock Modular Polycentric EBS Knee Joint 3R60, 3R60=ST, 3R60=KD, 3R60=HD. ... Otto Bock HealthCare GmbH is recalling Modular Polycentric EBS Knee Joint that were serviced betw... Class II Otto Bock Healthcare GmbH
Oct 23, 2015 iOS Galileo Application Version 1.1.1 or lower that programs the Triton Smart... A software issue can make the foot move into dorsiflexion, unnoticed by the user, who could fall.... Class II Otto Bock Healthcare GmbH
Jul 16, 2015 Ottobock Pheon 3R62 Knee Joint The 3R62 Pheon is a polycentric prosthetic ... Otto Bock Healthcare GmbH is voluntarily recalling all 3R62 Pheon polycentric prosthetic knee joi... Class II Otto Bock Healthcare GmbH

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.