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 37021–37040 of 38,428 recalls
Recalled Item: CapLOX II Final Torque Driver
The Issue: Captiva Spine recalled their CapLOX II Final Torque
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: The Trilogy Acetabular System Shell with Cluster Holes Porous 56
The Issue: Zimmer Trilogy¿ Acetabular System Shell with Cluster Holes,
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: GE Healthcare Optima XR 220amx Mobile general purpose radiographic imaging
The Issue: It was discovered GE Healthcare has become aware
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: GE Healthcare Optima XR 200amx with digital upgrade Mobile general
The Issue: It was discovered GE Healthcare has become aware
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: GE Healthcare Optima 200amx Mobile general purpose radiographic imaging of
The Issue: It was discovered GE Healthcare has become aware
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: SCP Pump Control Panel
The Issue: Sorin Group USA, Inc. has issued an Urgent
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: SCP Pump Control Panel
The Issue: Sorin Group USA, Inc. has issued an Urgent
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Terumo Advanced Perfusion System 1 Flow Module indicated for use
The Issue: Terumo Cardiovascular Systems (CVS) received one report of
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Valiant Thoracic Stent Graft with Captivia Delivery System
The Issue: Firm received reports of difficulty in flushing the
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Sorin C5 Perfusion System
The Issue: Sorin Group USA, Inc. has issued an Urgent
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: S5 Double Roller Pump 85
The Issue: Sorin Group USA, Inc. has issued an Urgent
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: S5 Single Roller Pump 150
The Issue: Sorin Group USA, Inc. has issued an Urgent
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: S5 Mast Roller Pump 150
The Issue: Sorin Group USA, Inc. has issued an Urgent
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: S5 Mast Roller Pump 85
The Issue: Sorin Group USA, Inc. has issued an Urgent
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Helion and Xenion surgical lights
The Issue: Incidents regarding fractures of the front joint of
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Male
The Issue: The firm initiated the product recall because labeling
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Iris Diagnostics Division iQ Control/Focus Set
The Issue: The firm initiated this recall because complaints from
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: CareStream Dental Kodak 2200 Intraoral X-ray system Product Usage: The
The Issue: There have been approximately 2% of the x-ray
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: CareStream Dental CS 2100 X-ray system Product Usage: The expected
The Issue: There have been approximately 2% of the x-ray
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: CareStream Dental Kodak 2100 Intraoral X-ray system Product Usage: The
The Issue: There have been approximately 2% of the x-ray
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.