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 15621–15640 of 38,428 recalls
Recalled Item: BIOMET Custom StageOne Hip Femoral Reinforcement
The Issue: Potentially insufficient cleaning process or potential inadequate process
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: BIOMET StageOne
The Issue: Potentially insufficient cleaning process or potential inadequate process
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: BIOMET StageOne Knee Femoral Cement Spacer Mold
The Issue: Potentially insufficient cleaning process or potential inadequate process
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: BIOMET StageOne Hip Cement Spacer Mold with Insert
The Issue: Potentially insufficient cleaning process or potential inadequate process
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: BIOMET StageOne Knee Tibial Cement Spacer Mold
The Issue: Potentially insufficient cleaning process or potential inadequate process
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: BIOMET StageOne Select
The Issue: Potentially insufficient cleaning process or potential inadequate process
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: HeartStart MRx Monitor/Defibrillators with model numbers M3535A M3536A
The Issue: Philips has received a number of reports of
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Rhythm Xience Guider Catheter Introducer with Lancer Intergrated...
The Issue: Foreign Object Contamination
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Nexus Universal with OptiBond Universal
The Issue: An issue within production process used to package
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Rhythm Xience Flextra Steerable Introducer with Lancer Integrated...
The Issue: Foreign Object Contamination
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Acutus Medical AcQGuide Flex Steerable Introducer with AcQcross QX Integrated
The Issue: Foreign Object Contamination
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Acutus Medical AcQGuide Mini Fixed-Curve Introducer with AcQCros QX Integrated
The Issue: Foreign Object Contamination
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Biomet Comprehensive Reverse Shoulder Glenosphere Mini Baseplate With Taper...
The Issue: Package is intended to contain one (1) baseplate
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Butterfly iQ Ultrasound System Auto Bladder Volume Tool-The Auto Bladder
The Issue: Distributed without an approved 510(k)
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Butterfly iQ Ultrasound System containing the Auto EF(Ejection Fraction) Tool
The Issue: Distributed without an approved 510(k)
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: LivaNova Heater-Cooler System 3T - Product Usage: The Heater-Cooler 3T
The Issue: The firm is providing validated cleaning and disinfection
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: R-F Injector Cannula. 18gx10cm-STERILE. REF/UDI: 257-1810/(01)00828788021496
The Issue: Incorrect expiration date on introduction cannula packaging
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: R-F Injector Cannula. 20gx10cm-STERILE. REF/UDI: 257-2010/(01)10818788022124
The Issue: Incorrect expiration date on introduction cannula packaging
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: AmniSure ROM Test
The Issue: An image on the associated polybag contains an
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: TCM4 Base unit
The Issue: Reports have been received about the transcutaneous monitoring
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.