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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
Jun 4, 2014 Stride Femoral Component Size 2, PFSI-00054, Right Medial /Left Lateral. Unic... Mislabeled. Packages labeled PFSI-00053, Right Lateral/Left Medial contains PFSI-00054, Right Me... Class II Blue Belt Technologies MN
Jun 4, 2014 Stride Femoral Component Size 2, PFSI-00053, Right Lateral /Left Medial. Unic... Mislabeled. Packages labeled PFSI-00053, Right Lateral/Left Medial contains PFSI-00054, Right Me... Class II Blue Belt Technologies MN
Apr 11, 2014 NavioPFSTM System, Orthopedic Sterotaxic Instrument, model #'s NPFS-02000, N... Blue Belt Technologies is conducting a voluntary recall for their Navio PFS system which is used ... Class II Blue Belt Technologies MN
Jul 19, 2013 Blue Belt Technologies, Inc. Monitor Drape REF: PFSD-V0001, Rx only, Sterile... Blue Belt Technologies is recalling sterile Monitor Drapes used with their Navio PFS system durin... Class II Blue Belt Technologies MN

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.