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 29981–30000 of 38,428 recalls
Recalled Item: GE Healthcare Innova IGS 520. Angiographic X-ray systems used in
The Issue: GE Healthcare has recently become aware of a
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: GE Healthcare Innova 2100IQ. Angiographic X-ray systems used in generating
The Issue: GE Healthcare has recently become aware of a
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Infinite M1000 PRO in vitro diagnostic. Product Usage: The Tecan
The Issue: A firmware bug causes incorrect values to be
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Infinite M1000 in vitro diagnostic. Product Usage: The Tecan Infinite
The Issue: A firmware bug causes incorrect values to be
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Infinite 200 PRO in vitro diagnostic. Product Usage: The Tecan
The Issue: A firmware bug causes incorrect values to be
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: GE Healthcare Innova IGS 530. Angiographic X-ray systems used in
The Issue: GE Healthcare has recently become aware of a
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: GE Healthcare Innova IGS 630. Angiographic X-ray systems used in
The Issue: GE Healthcare has recently become aware of a
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: GE Healthcare Innova IGS 620. Angiographic X-ray systems used in
The Issue: GE Healthcare has recently become aware of a
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: GE Healthcare Discovery IGS 740 & GE Healthcare Innova IGS
The Issue: GE Healthcare has recently become aware of a
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: GE Healthcare Innova 3100IQ. Angiographic X-ray systems used in generating
The Issue: GE Healthcare has recently become aware of a
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Infinite 200 in vitro diagnostic. Product Usage: The Tecan Infinite
The Issue: A firmware bug causes incorrect values to be
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: GE Healthcare Innova IGS 540. Angiographic X-ray systems used in
The Issue: GE Healthcare has recently become aware of a
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: GE Healthcare Innova 3131IQ. Angiographic X-ray systems used in generating
The Issue: GE Healthcare has recently become aware of a
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: ELI 380 Electrocardiograph. The ELI 380 is intended to be a high-performance
The Issue: Mortara Instrument, Inc. has recently become aware of
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: AGFA DX-D 100 is a mobile digital radiography x-ray system
The Issue: When using the DX-D 100 unit, sporadic unintended
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Surgical Display
The Issue: User settings were no longer on the monitor's
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Sureflex 910 Lithotripsy Fiber
The Issue: validation data related to cleaning instructions and sterilization
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Tool
The Issue: validation data related to cleaning instructions and sterilization
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Tool
The Issue: validation data related to cleaning instructions and sterilization
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Fiber Cleaver
The Issue: validation data related to cleaning instructions and sterilization
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.