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 8481–8500 of 38,428 recalls
Recalled Item: DYND3000xxP Series - Flexible Laryngeal Mask Airway Packs
The Issue: The case and each (i.e. packet) labels for
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: YelloPort Elite
The Issue: Optical Trocars sterility assurance can not be guaranteed
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: YelloPort Elite
The Issue: Optical Trocars sterility assurance can not be guaranteed
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Centricity PACS-IW with Universal Viewer
The Issue: GE HealthCare has become aware of an issue
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Centricity Universal Viewer
The Issue: GE HealthCare has become aware of an issue
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Centricity PACS-IW
The Issue: GE HealthCare has become aware of an issue
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Omnicell IVX Station-For use in the automated preparation of pharmaceutical
The Issue: IVX Station does not account for inherent scale
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Immundiagnostik IDK Lactoferrin ELISA- In vitro enzyme immunoassay intended for
The Issue: Marketed without a 510k
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: TDHisto/Cyto - A software product used for managing medical information
The Issue: In a specific use case, when printing labels
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: GEM NEUROTUBE
The Issue: The product is brittle and potentially crumbling upon
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: JOURNEY II UNI XLPE TIBIA INSERT MEDIAL SZ 7-8 8MM
The Issue: A mispack occurred during the manufacturing process, resulting
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: ANGIOGUARD RX / XP Emboli Capture Guidewire System
The Issue: There is a potential for separation of the
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: ANGIOGUARD RX / XP Emboli Capture Guidewire System
The Issue: There is a potential for separation of the
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: ANGIOGUARD RX / XP Emboli Capture Guidewire System
The Issue: There is a potential for separation of the
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: ANGIOGUARD RX / XP Emboli Capture Guidewire System
The Issue: There is a potential for separation of the
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: ANGIOGUARD RX / XP Emboli Capture Guidewire System
The Issue: There is a potential for separation of the
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: ANGIOGUARD RX / XP Emboli Capture Guidewire System
The Issue: There is a potential for separation of the
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: ANGIOGUARD RX / XP Emboli Capture Guidewire System
The Issue: There is a potential for separation of the
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: ANGIOGUARD RX / XP Emboli Capture Guidewire System
The Issue: There is a potential for separation of the
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: ANGIOGUARD RX / XP Emboli Capture Guidewire System
The Issue: There is a potential for separation of the
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.