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 8721–8740 of 38,428 recalls
Recalled Item: INFINITY Occipitocervical Upper Thoracic System
The Issue: Incorrect type of titanium was used which reduces
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: thermage THERMAGE CPT SYSTEM *** Solta Medical
The Issue: A service unit was potentially improperly tested and
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: FoundationOne Companion Diagnostic (F1CDx)
The Issue: An incorrect negative claim was identified on the
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: KLS Martin Battery Pack
The Issue: Battery packs used in surgical procedures where a
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Flex-Neck Catheter External Repair Kit LOT CE-1400/A
The Issue: Product that was built for design verification testing
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Attune Revision Limb Preservation System (LPS) Tibial Insert XXSM 18MM
The Issue: The subject product lots are being recalled because
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Attune Revision Limb Preservation System (LPS) Tibial Insert SM 12MM
The Issue: The subject product lots are being recalled because
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Attune Revision Limb Preservation System (LPS) Tibial Insert XSM 12MM
The Issue: The subject product lots are being recalled because
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Attune Revision Limb Preservation System (LPS) Tibial Insert XSM 26MM
The Issue: The subject product lots are being recalled because
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Attune Posterior (PS) Fixed Bearing (FB) Tibial Insert SZ5 7MM
The Issue: The subject product lots are being recalled because
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: BD Pyxis MedStation ES AUX Tower BD Pyxis
The Issue: Due to an increase in complaints of door
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: BD Pyxis Med ES Auxiliary (AUX)
The Issue: Drawer and/or door failures that may lead to
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: BD Pyxis MedStation 4000 Main
The Issue: Drawer and/or door failures that may lead to
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: BD Pyxis Med 4000 Auxiliary (AUX)
The Issue: Drawer and/or door failures that may lead to
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: BD Pyxis MedStation ES (Med ES Main)
The Issue: Drawer and/or door failures that may lead to
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: BD Pyxis MedStation 4000 AUX
The Issue: Drawer and/or door failures that may lead to
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: BD Pyxis MedStation ES AUX
The Issue: Drawer and/or door failures that may lead to
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: KLS martin Group KLS E-COUPLING ADAPTER E-Coupling Adapter
The Issue: Incorrect Unique Device Identifier/GTIN code was used on
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Edward Lifesciences
The Issue: There is a potential that the distal end
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Edward Lifesciences
The Issue: There is a potential that the distal end
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.