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 32901–32920 of 38,428 recalls
Recalled Item: Gel-E Donut
The Issue: The gel-filled Gel-E Donut and Squishon product line
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Siemens Linear Accelerators of type ARTISTE
The Issue: A safety risk exists with automatically sequenced treatment
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Shape HF Cardiopulmonary System. Made up of Shape HF System
The Issue: Shape Medical has initiated a correction due to
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: 07-150-07 MIZUHO
The Issue: Report of the product penetrating the sterile barrier;
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: 07-150-10 MIZUHO
The Issue: Report of the product penetrating the sterile barrier;
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: 07-150-12 MIZUHO
The Issue: Report of the product penetrating the sterile barrier;
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: HydroFinity Hydrophilic guidewire
The Issue: Reports of outer polymer jacket to the core
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: HydroFinity Hydrophilic guidewire
The Issue: Reports of outer polymer jacket to the core
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: HydroFinity Hydrophilic guidewire
The Issue: Reports of outer polymer jacket to the core
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: HydroFinity Hydrophilic guidewire
The Issue: Reports of outer polymer jacket to the core
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: HydroFinity Hydrophilic guidewire
The Issue: Reports of outer polymer jacket to the core
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: HydroFinity Hydrophilic guidewire
The Issue: Reports of outer polymer jacket to the core
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: HydroFinity Hydrophilic guidewire
The Issue: Reports of outer polymer jacket to the core
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: HydroFinity Hydrophilic guidewire
The Issue: Reports of outer polymer jacket to the core
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Abacus 3.1
The Issue: Baxter Corporation is initiating a field correction following
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: HydroFinity Hydrophilic guidewire
The Issue: Reports of outer polymer jacket to the core
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: HydroFinity Hydrophilic guidewire
The Issue: Reports of outer polymer jacket to the core
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: HydroFinity Hydrophilic guidewire
The Issue: Reports of outer polymer jacket to the core
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: HydroFinity Hydrophilic guidewire
The Issue: Reports of outer polymer jacket to the core
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Dimension¿ Integrated Chemistry Systems intended to measure a variety of
The Issue: There is a misassembly issue with the photometer
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.