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 11621–11640 of 38,428 recalls
Recalled Item: DigitalDiagnost C90
The Issue: The Aleva monitor requires certain labels to be
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: ProxiDiagnost N90 is multi-functional general R/F systems.
The Issue: The Aleva monitor requires certain labels to be
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: QuikClot Combat Gauze-For Temporary External Use To Control Traumatic Bleeding
The Issue: Lack of Packaging seal integrity may result in
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: ADVIA Centaur SARS-CoV-2 Antigen Assay (100 Test Kit)
The Issue: Data provided in the Emergency Use Authorization (EUA)
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Atellica IM SARS-CoV-2 Antigen Assay (100 Test Kit)
The Issue: Data provided in the Emergency Use Authorization (EUA)
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: ROSA One 3.1 Brain application The device is intended for
The Issue: The firm has become aware of a software
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: The da Vinci Xi and X surgical systems (IS4000 and
The Issue: Incorrect expiration date on its package labeling (shipper
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: ASC PneumoLiner device
The Issue: Due to manufacturing error, the Pneumoliner Bag Distal
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Cardiosave Li-Ion Battery Pack
The Issue: A Cardiosave Lithium-Ion Battery Pack used during protocol
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: EPIQ CVxi Diagnostic Ultrasound Systems
The Issue: Ultrasound system software issue can cause an EchoNavigator
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Arrow-Trerotola Over-The-Wire PTD Kit Percutaneous Thrombolytic Device : 7FR...
The Issue: 7FR Percutaneous Thrombolytic Device (PTD) Inner lumen (orange)
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Arrow-Trerotola Over-The-Wire PTD Kit Percutaneous Thrombolytic Device : 7FR...
The Issue: 7FR Percutaneous Thrombolytic Device (PTD) Inner lumen (orange)
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Arrow-Trerotola Over-The-Wire PTD Kit Percutaneous Thrombolytic Device : 7FR...
The Issue: 7FR Percutaneous Thrombolytic Device (PTD) Inner lumen (orange)
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Arrow-Trerotola Over-The-Wire PTD Kit Percutaneous Thrombolytic Device : 7FR...
The Issue: 7FR Percutaneous Thrombolytic Device (PTD) Inner lumen (orange)
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Advia Chemistry Urinary/Cerebrospinal Fluid Protein (UCFP)
The Issue: The firm has confirmed the potential for ADVIA
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Atellica CH Urinary/Cerebrospinal Fluid Protein (UCFP)
The Issue: The firm has confirmed the potential for Atellica
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: 6.5MMX165MM CANNULATED SCREW
The Issue: The product label incorrectly indicated that the screws
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: BIO-RAD BioPlex 2200 Syphilis Total & RPR Calibrator
The Issue: Due to two issues: 1) Customer complaints associated
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: BIO-RAD BioPlex 2200 SYPH T PACK Syphilis Total
The Issue: Due to two issues: 1) Customer complaints associated
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Elekta Medical Linear Accelerator (EMLA)
The Issue: There is a risk that the Diode D1
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.