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 17221–17240 of 38,428 recalls
Recalled Item: Aespire 7100
The Issue: Certain Aespire and Aestiva Anesthesia Systems were noted
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Aestiva 7100
The Issue: Certain Aespire and Aestiva Anesthesia Systems were noted
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Aestiva MRI
The Issue: Certain Aespire and Aestiva Anesthesia Systems were noted
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Philips 5-Lead Set
The Issue: The thickness of the connector to the trunk
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: DIATECH
The Issue: A single batch of Diatech Diamond dental burs,
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: AMS 800 Artificial Urinary Sphincter AMS 800 Belt Cuff
The Issue: Mislabled: AMS 800 occlusive cuff labeled as 4.5
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Fujifilm FDR Go Plus mobile X-ray system
The Issue: The graphics driver of the FDR Go PLUS
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: ZYMUTEST HIA MonoStrip
The Issue: Residual crystallization of the microplate and recurrent negative
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: ZYMUTEST HIA MonoStrip
The Issue: Residual crystallization of the microplate and recurrent negative
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: MICRO-TEMP LT System
The Issue: Updated Manual-Warnigs have been added stating that exceeding
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Codman ISOCOOL Bipolar Forceps-are indicated for cauterizing
The Issue: Tips have an inadequate product insulation coating, which
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Cardinal Health Brand 120mL/53mm sterile
The Issue: Cardinal Health branded specimen containers, may potentially contain
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Cardinal Health Brand 120mL/53mm sterile specimen container with orange cap
The Issue: Cardinal Health branded specimen containers, may potentially contain
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Arrow AGB+ Multi-Lumen CVC Kit-catheter permits venous access to central
The Issue: Arrow AGB+ Multi-Lumen CVC Kit - lidstock incorrectly
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: cobas e 601 module (cobas 6000 Modular Series system) Part Number: 04745922001
The Issue: Quality issue with high pressure solenoid valves may
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: cobas c513 Analyzer
The Issue: Quality issue with high pressure solenoid valves
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Cobas 8000 Modular Analyzer Series: cobas 8000 ISE module part
The Issue: Quality issue with high pressure solenoid valves
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: IGuide System
The Issue: Sometimes, although the HexaPOD has reached the target
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Autoject EI
The Issue: There is a possible assembly error on Autoject
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Petfine Auto Injector
The Issue: There is a possible assembly error on Autoject
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.