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Browse Device Recalls

7 FDA medical device safety recalls.

FDA Medical Device Recall Enforcement Database

Browse 7 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 7 FDA device recalls.

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DateProductReasonClassFirm
Aug 10, 2012 IDS-iSYS Ostase¿ BAP (Bone Alkaline Phosphatase), Catalog Number IS-2800. Pac... It has been noted by staff at IDS Inc. that stock of the affected products held at IDS Inc. are l... Class II Immunodiagnostics Systems Ltd
Aug 10, 2012 IDS-iSYS Intact PINP, Catalog Number IS-4000. Packaged in cardboard Box conta... It has been noted by staff at IDS Inc. that stock of the affected products held at IDS Inc. are l... Class II Immunodiagnostics Systems Ltd
Aug 10, 2012 IDS-iSYS N-Mid¿ Osteocalcin, Catalog Number IS-2930. Packaged in cardboard Bo... It has been noted by staff at IDS Inc. that stock of the affected products held at IDS Inc. are l... Class II Immunodiagnostics Systems Ltd
Aug 10, 2012 IDS-iSYS Intact PINP Control Set, Catalog Number IS-4030. Packaged in cardboa... It has been noted by staff at IDS Inc. that stock of the affected products held at IDS Inc. are l... Class II Immunodiagnostics Systems Ltd
Aug 10, 2012 IDS-iSYS Ostase¿ BAP (Bone Alkaline Phosphatase) Control Set, Catalog Number ... It has been noted by staff at IDS Inc. that stock of the affected products held at IDS Inc. are l... Class II Immunodiagnostics Systems Ltd
Aug 10, 2012 IDS Urine BETA CrossLaps ELISA, Catalog Number AC-05F1. Type of packaging: Ca... It has been noted by staff at IDS Inc. that stock of the affected products held at IDS Inc. are l... Class II Immunodiagnostics Systems Ltd
Aug 10, 2012 IDS-iSYS N-Mid¿ Osteocalcin, Catalog Number IS-2900. Packaged in cardboard Bo... It has been noted by staff at IDS Inc. that stock of the affected products held at IDS Inc. are l... Class II Immunodiagnostics Systems Ltd

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.