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 19861–19880 of 38,428 recalls
Recalled Item: TriMed Olecranon Hook Plate
The Issue: The firm has become aware that the angled-hole
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: MassHunter Quantitative Analysis Software
The Issue: When utilizing specific software versions of an LC/MS
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: VITROS 5600 Integrated System- (). For use in the in
The Issue: for the VITROS 5600 Integrated System to
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: VITROS 5600 Integrated System-For use in the in vitro quantitative
The Issue: for the VITROS 5600 Integrated System to
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: DX-D 600 Product Usage: The DX-D 600 system is a
The Issue: A supplier for the Agfa system noted a
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Permobil powered wheelchairs
The Issue: This correction decision has been made because of
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: da Vinci S/Si EndoWrist 8mm Monopolar Curved Scissors Model No.
The Issue: Monopolar Curved Scissor (MCS) instruments may be susceptible
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: da Vinci X/Xi EndoWrist 8mm Monopolar Curved Scissors Model No.
The Issue: Monopolar Curved Scissor (MCS) instruments may be susceptible
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Alcon Air Optix Night & Day Aqua (lotrafilcon A)
The Issue: The product may be counterfeit and could have
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: TECOTHERM NEO
The Issue: The action is being initiated due to potential
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: APTIO 15000 STORAGE MODULE
The Issue: The modules may have been shipped without a
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: APTIO RACK INPUT MODULE
The Issue: The modules may have been shipped without a
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: STREAMLAB CORE UNIT / LYNX WITH IOM
The Issue: The modules may have been shipped without a
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: APTIO INPUT/OUTPUT MODULE
The Issue: The modules may have been shipped without a
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: STREAMLAB - STORAGE MODULE 9000
The Issue: The modules may have been shipped without a
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: STREAMLAB - STORAGE MODULE 15000
The Issue: The modules may have been shipped without a
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: APTIO RACK OUTPUT MODULE
The Issue: The modules may have been shipped without a
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: APTIO 9000 STORAGE MODULE
The Issue: The modules may have been shipped without a
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: APTIO CENTRIFUGE MODULE
The Issue: The modules may have been shipped without a
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Portable Suction Pump
The Issue: The care-e-vac(R)3 Battery/AC Powered Portable Aspirator battery terminal
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.