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 27081–27100 of 38,428 recalls
Recalled Item: Pediatric Dual Dispersive Electrodes (for patients 5-15 kg.)
The Issue: A version of the dual dispersive electrodes may
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: VITROS Chemistry Products Ca Slides
The Issue: Ortho Clinical Diagnostics (OCD) confirmed a potential for
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Monaco RTP System Product Usage: The Monaco system is used
The Issue: When DICOM exporting a 3D Monaco plan and
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Calix T PEEK Lumbar System
The Issue: The trials and rasps used to prepare the
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Calix P PEEK Lumbar System
The Issue: The trials and rasps used to prepare the
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Calix P PEEK Lumbar System
The Issue: The trials and rasps used to prepare the
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Calix T PEEK Lumbar System
The Issue: The trials and rasps used to prepare the
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Dimension Vista¿ Homocysteine Flex Reagent Cartridge (HCYS)
The Issue: Reagent lots # 15243MA and 15243MB shows a
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: cobas¿ Liat Influenza A/B Quality Control Kit
The Issue: Kit labeled with the incorrect expiration date
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Access 2 Immunoassay System
The Issue: Due to the lack of updated thermal components,
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Gas Delivery Engine (GDE)
The Issue: CareFusion has identified a potential risk associated with
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Gas Delivery Engine (GDE)-
The Issue: CareFusion has identified a potential risk associated with
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: TCA Board
The Issue: CareFusion has identified a potential risk associated with
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: AVEA Standard with Compressor ventilator-
The Issue: CareFusion has identified a potential risk associated with
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Dome Centric component ( 01.04227.005) from the Anatomical Shoulder (AS)
The Issue: In some cases it has been difficult or
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: AVEA Standard ventilator
The Issue: CareFusion has identified a potential risk associated with
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: AVEA GDE/UIM upgrade kit
The Issue: CareFusion has identified a potential risk associated with
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Gas Delivery Engine (GDE)-1st Generation
The Issue: CareFusion has identified a potential risk associated with
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: AVEA Standard with Compressor ventilator
The Issue: CareFusion has identified a potential risk associated with
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: AVEA GDE upgrade kit
The Issue: CareFusion has identified a potential risk associated with
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.