Medical Device Recalls
This is our largest category by volume. The FDA tracks recalls for an enormous range of medical devices: implants, pacemakers, insulin pumps, surgical tools, blood glucose monitors, X-ray machines, prosthetics, contact lenses, and home health equipment, among many others. We have records dating back to 2005 and add new ones as the FDA publishes them.
Device recalls can happen because of software bugs, manufacturing defects, bacterial contamination, incorrect labeling, or design flaws that lead to inaccurate results or equipment failure. Class I recalls are the most serious and mean the device could cause injury or death.
Showing 24721–24740 of 38,428 recalls
Recalled Item: uNion Cervical Plate System Product Usage: The uNion Cervical Plate
The Issue: Surgical technique was revised to prevent static plate
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Bush DL Ureteral Illuminating Catheter Set Bush SL Ureteral Illuminating
The Issue: Product may overheat, melt, and burn patient
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: VITROS Immunodiagnostic Products NT-pro BNP Reagent Pack
The Issue: Increased frequency of calibration failures for VITROS Immunodiagnostic
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: AESCULAP MINOP InVent 30 Trocar System
The Issue: Aesculap Implant Systems LLC is recalling the Minop
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Specimen Gate Laboratory
The Issue: for errors in patient results generated by
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Access 2 assay Immunoassay System
The Issue: Beckman Coulter is recalling the Access 2 Family
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: NucliSENS Lysis Buffer
The Issue: Problem with colored eluates for whole blood extractions
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: UniCel DxC 600i SYNCHRON Access Clinical System
The Issue: Beckman Coulter is recalling the Access 2 Family
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Access 2 Immunoassay Systems
The Issue: Beckman Coulter is recalling the Access 2 Family
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Philips IntelliVue MX4O WLAN Patient Wearable Monitor Product: 865352 Exchange
The Issue: Philips lntelliVue MX4O WLAN Patient Wearable Monitor may
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Syngo.x
The Issue: Software changes now available to address several issues
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Syngo.via
The Issue: Software changes now available to address several issues
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: ImplantDirect
The Issue: The main vial label lists the incorrect part
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: LASEREDGE Knives
The Issue: The complaints database was reviewed and there have
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: LASEREDGE Knives
The Issue: The complaints database was reviewed and there have
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: LASEREDGE Knives
The Issue: The complaints database was reviewed and there have
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: LASEREDGE Knives
The Issue: The complaints database was reviewed and there have
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: LASEREDGE Knives
The Issue: The complaints database was reviewed and there have
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: LASEREDGE Knives
The Issue: The complaints database was reviewed and there have
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: LASEREDGE Knives
The Issue: The complaints database was reviewed and there have
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.