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 12621–12640 of 38,428 recalls
Recalled Item: Critical Care Ventilator
The Issue: Three separate and unrelated problems attributed to the
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: The Terumo HX2 Temperature Management System provides temperature control of
The Issue: Terumo CVS has been unable to validate a
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Nimbus 4 and Nimbus Professional Alternating-pressure bed mattress overlay...
The Issue: There is a potential for abnormal inflation of
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Vygon Dressing Change w/ Maxiswab - Product Usage: Custom Dressing Change kit
The Issue: Compromised sterile barriers due to the Tyvek Lid
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: T25 Cannulated Screwdrivers (CSD 025) packaged in Guide Wire Kits
The Issue: Cannulated Screwdrivers may break at the driver tip
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Eyesuite 9.3.1 software
The Issue: Examination data and patient name may be mixed
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: UpsylonTM Y Mesh Kit with Colpassist Vaginal Positioning Device -
The Issue: for pinholes (sterile barrier breach) on the
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Colpassist Vaginal Positioning Device - Product Usage: intended for use
The Issue: for pinholes (sterile barrier breach) on the
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Illuminated Stepped Laser Probe Curved-for use in combination with 23G
The Issue: Barcode label extended expiration date. Barcode located at
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: E3800 PC Units (spare parts)
The Issue: Due to an issue with the internal clock
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Radiometer ABL90 FLEX Analyzer with E3800 PC units. The E3800
The Issue: Due to an issue with the internal clock
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Radiometer ABL90 FLEX PLUS Analyzer with E3800 PC units. The
The Issue: Due to an issue with the internal clock
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Access SARS-CoV-2 Antigen
The Issue: specimens collected in transport media may result is
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Gambro Cartridge Blood Set
The Issue: There is a potential leak between the venous
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: BRILLIANCE VOLUME system - A Computed Tomography X-Ray System intended
The Issue: Cooling Unit (CLU) expelled out of a CT
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: VICI VENOUS STENT System Product Usage: is intended for the
The Issue: The firm has received reports of stent migration
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: VICI RDS VENOUS STENT System Product Usage: is indicated for
The Issue: The firm has received reports of stent migration
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: DONJOY ULTRASLING PRO ER/IR 30
The Issue: failed rivet at the chafe tab of arm
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: DONJOY ULTRASLING PRO AB
The Issue: failed rivet at the chafe tab of arm
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: DONJOY PRO
The Issue: failed rivet at the chafe tab of arm
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.