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 32261–32280 of 38,428 recalls
Recalled Item: Cardiopulmonary bypass connector
The Issue: The single leg of the PAY connector has
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Covidien Kendall Adult Multi-Function Defibrillation Electrodes Part Number:...
The Issue: Covidien Medi-Trace Cadence and Kendall Defibrillation Electrodes Not
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Siemens Mammomat Inspiration mammography systems. The Mammomat Inspiration...
The Issue: The stereo biopsy devices for Mammomat Inspiration mammography
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Coviden Medi-Trace Cadence Adult Multi-Function Defibrillation Electrodes
The Issue: Covidien Medi-Trace Cadence and Kendall Defibrillation Electrodes Not
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: V.A.C. GranuFoam Silver Large Dressing is barrier to bacterial penetration
The Issue: A portion of the V.A.C. GranuFoam Silver Dressing
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Multi-Lumen Central Venous Catheterization Kit
The Issue: Arrow International, Inc. has initiated a voluntary recall
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Covidien Medi-Trace Cadence and Kendall Adult Multi-Function Defibrillation...
The Issue: Covidien Medi-Trace Cadence and Kendall Defibrillation Electrodes Not
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: EndoWrist Stapler 45 instrument for the da Vinci Si System
The Issue: Intuitive is issuing an urgent product notice to
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Covidien Kendall 1710H Multi-Function Defibrillation Electrodes Part Number:...
The Issue: Covidien Medi-Trace Cadence and Kendall Defibrillation Electrodes Not
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: MediChoice¿ Multifunction Electrode Part Number: MC171 OH
The Issue: Covidien Medi-Trace Cadence and Kendall Defibrillation Electrodes Not
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Philips HEARTSTART Multifunction Electrode Pads Part Number: M3718A
The Issue: Covidien Medi-Trace Cadence and Kendall Defibrillation Electrodes Not
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: nordicBrainEx 2.0 provides analysis and visualization capabilities of...
The Issue: An error was discovered in the interpretation of
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Artis zee/ zeego systems
The Issue: The Small Focus of a 3 focal spot
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Compress Face Reamer Product Usage: Correction of revision of unsuccessful
The Issue: Investigation determined that units supplied were missing the
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: ProClear Toric contact lenses are made from a material containing
The Issue: Routine quality monitoring system has identified that a
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Esprit V1000 and V200 Ventilators
The Issue: A failure of a specific component may prevent
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Boston Scientific TELIGEN
The Issue: Boston Scientific identified a subset of COGNISTM CRT-Ds
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Boston Scientific COGNIS CRT-D
The Issue: Boston Scientific identified a subset of COGNISTM CRT-Ds
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: EndoWrist One Vessel Sealer used in conjunction with the da
The Issue: Intuitive Surgical is initiating a voluntary correction relating
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Cardinal Health Prefilled Buffered 10% Formalin. Product Usage:10% NBF is
The Issue: The affected lots could have NBF concentrations that
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.