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 12061–12080 of 38,428 recalls
Recalled Item: Cardinal Health Beta-Hydroxybutyrate LiquiColor for Synchron CX/LX/DX. in...
The Issue: Deterioration in the stability of the reagents which
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: COPAN FLOQSwabs
The Issue: A sterility assurance level of 10-6 cannot be
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: AQUABEAM Handpiece
The Issue: Scope tube tip may detach from the telescoping
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: CIRCUL8 LUXE DVT PREVENTION DEVICE
The Issue: CIRCUL8 LUXE DVT PREVENTION DEVICE is marketed without
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: EVEXIA LUXE DVT PREVENTION DEVICE
The Issue: EVEXIA LUXE DVT PREVENTION DEVICE is marketed without
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Edwards PediaSat Oximetry Catheter Set
The Issue: There is a potential for internal leaks within
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Edwards PediaSat Oximetry Catheter Set
The Issue: There is a potential for internal leaks within
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Edwards PediaSat Oximetry Catheter Kit
The Issue: There is a potential for internal leaks within
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Edwards PediaSat Oximetry Catheter Kit
The Issue: There is a potential for internal leaks within
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Edwards PediaSat Oximetry Catheter Set
The Issue: There is a potential for internal leaks within
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Edwards PediaSat Oximetry Catheter Kit
The Issue: There is a potential for internal leaks within
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Medtronic Vectris SureScan MRI
The Issue: Specific PINs of the Vectris SureScan MRI lead
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: The Instructions for Use (IFU) for: Gelsoft Plus Bifurcate
The Issue: The devices contained the IFU for distribution to
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: The Instructions for Use (IFU) for: Carotid Patch and Gelsoft
The Issue: The devices contained the IFU for distribution to
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Scorpion Portal Vein Access Set - Product Usage: used to
The Issue: As a result of design changes, sheaths have
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Chassis Label - "CIRRUS HD-OCT Rx-Only" Product Label Exterior RX
The Issue: Due to failure to acquire pre-market clearance for
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Zippie Voyage
The Issue: The seating system unexpectedly detached, which resulted in
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Zippie Voyage
The Issue: The seating system unexpectedly detached, which resulted in
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Dose IQ Safety Software used with Spectrum IQ Infusion Pump
The Issue: Software issue: The defect creates a mismatch between
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Atellica IM BR 27.29 (BR) Assay 250 Test Kit ()-
The Issue: Product does not meet the Instructions for Use
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.