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 14341–14360 of 38,428 recalls
Recalled Item: Endo GIA Auto Suture Universal Articulating Loading Unit 30 mm - 2.5 mm
The Issue: The device staples may not properly form upon
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Endo GIA Auto Suture Universal Articulating Loading Unit 45 mm - 3.5 mm
The Issue: The device staples may not properly form upon
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Central Line Dressing Change Tray
The Issue: of incomplete seals impacting the sterility of
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Lactate Dehydrognease P-L
The Issue: An update to the carryover avoidance technical bulletin
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Lactate Dehydrogenase L-P
The Issue: An update to the carryover avoidance technical bulletin
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Zenith Alpha Abdominal Endovascular Graft - Distributed OUS only. Indicated
The Issue: May contain excess glue within the handle of
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: The Vantage Total Ankle Tibial Insert
The Issue: The Vantage Total Ankle Tibial Insert, Fixed Bearing,
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: RSP Standard HUMERAL SOCKET INSERT
The Issue: Mislabeling
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: RSP Standard HUMERAL SOCKET INSERT
The Issue: Mislabeling
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Tosoh Bioscience AIA-PACK BHCG Calibration Verification Test Set-In Vitro...
The Issue: Decreased stability for five (5) lots of Calibrator
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Maquet/Getinge Rotaflow System Console US (115 V / 60 Hz)
The Issue: Instruction For Use (IFU) references incorrect serial number
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Tosoh Bioscience AIA- PACK HCG Calibrator Set-In Vitro Diagnostic for
The Issue: Decreased stability for five (5) lots of Calibrator
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Accelerator a3600 system with Sysmex XN-9000/XN-9100 Interface Module (dual...
The Issue: Firmware of the Sysmex XN-9000/XN-9100 Interface Module (IM)
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Aptio Automation systems with Sysmex XN-9000/XN-9100 Interface Module (dual...
The Issue: Firmware of the Sysmex XN-9000/XN-9100 Interface Module (IM)
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: WallFlexTM Biliary RX Fully Covered Stent System RMV (10mmx60mm Stent)
The Issue: Mislabeling
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: FlexLab (FLX) with Sysmex XN-9000/XN-9100 Interface Module (dual robot)...
The Issue: Firmware of the Sysmex XN-9000/XN-9100 Interface Module (IM)
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Pleur-evac Thoracic Catheters Catalog No: DTRC-20S The thoracic catheter is
The Issue: sterility issue
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: PC Application Software c4D as part of the device Catalyst:
The Issue: PC Application Software c4D not changing Site upon
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Carl Zeiss Meditec AG VISUREF150 - Product Usage:
The Issue: Due to the incorrect DC/DC converter being assembled
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Carl Zeiss Meditec Ag VISULENS 550 - Product
The Issue: Due to the incorrect DC/DC converter being assembled
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.