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 30101–30120 of 38,428 recalls
Recalled Item: BrainLAB Image Guided Surgery (IGS) System
The Issue: Instances of data sets not being accurately registered
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Toshiba Aquilion CT System TSX-301C
The Issue: If two specific operations are performed in multi-phase
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Toshiba Aquilion CT System TSX-303A
The Issue: If two specific operations are performed in multi-phase
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Toshiba Aquilion CT System TSX-301A
The Issue: If two specific operations are performed in multi-phase
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Toshiba Aquilion CT System TSX-302A
The Issue: If two specific operations are performed in multi-phase
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Toshiba Aquilion CT System TSX-101A
The Issue: If two specific operations are performed in multi-phase
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Toshiba Aquilion CT System TSX-301B
The Issue: If two specific operations are performed in multi-phase
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Celesteion PCA-9000A/2 PET/CT System
The Issue: It was found that if specific operations are
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: 0210-312-000-Woundcare Replacement kit with soft tip
The Issue: sterility breach in the packaging
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Shiley Neonatal
The Issue: Reports where patients who recently switched from the
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Shiley Neonatal
The Issue: Reports where patients who recently switched from the
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Ethicon Fast Absorbing Plain Gut - MultiPass Needles
The Issue: Ethicon Fast Absorbing Surgical Gut (Plain) Suture is
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Spacelabs qube Compact Monitor
The Issue: The input power can fail even though the
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Gyrus ACMI Diego Elite Tubeset
The Issue: lack of sterility assurance
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Gyrus ACMI Diego Elite Tubeset
The Issue: lack of sterility assurance
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: RaySearch RayStation 2.5
The Issue: RaySearch Laboratories AB became aware of an issue
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Treatment Planning and Delivery System Software version 3.6. ViewRay. Indicated
The Issue: The software was failing to determine new patient
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: HDL-Cholesterol gen.3. For the quantitative determination of high-density...
The Issue: drug interference when using the Trinder reaction
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Creatinine Plus ver. 2. Intended for use on COBAS INTEGRA systems
The Issue: drug interference when using the Trinder reaction
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Ocean Water Seal Chest Drain
The Issue: Chest drains have a missing o-ring
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.