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 12701–12720 of 38,428 recalls
Recalled Item: GORE VIBIL Biliary Endoprosthesis: stents
The Issue: The Gore post market surveillance team received a
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Tranberg MR Stylet
The Issue: single use devices labeled as sterile may not
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Tranberg MR Cannula
The Issue: single use devices labeled as sterile may not
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Tranberg Laser Applicator Non-cooled
The Issue: single use devices labeled as sterile may not
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: DirectInject consists of a sterile dual paste system which is
The Issue: Inability for the user to inject the paste
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Power Wheelchair
The Issue: Seat baseplate pin has broken in the field
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Scooter
The Issue: Seat baseplate pin has broken in the field
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: SoftGenomics version 4.1.15.6 SoftGenomics is a laboratory workflow and...
The Issue: Software showing wrong results reported, PDF not match
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: SoftCytogenetics
The Issue: Software is given wrong results going out to
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: ACE MDI Spacer with Small Mask - Product Usage: designed
The Issue: The firm became aware via complaints that one
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Palm Cups - Product Usage: intended to be used to
The Issue: The firm became aware via complaints that one
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Tubing with male luer lock adapter (Component) a. 76 cm
The Issue: Specific lots of Medex High Pressure Adaptors, Rotators,
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Left Heart Kit
The Issue: Specific lots of Medex High Pressure Adaptors, Rotators,
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Stopcock rotator (Component): a. 1050 STOPCOCK ROTATOR
The Issue: Specific lots of Medex High Pressure Adaptors, Rotators,
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: LogiCal Monitoring Set
The Issue: Specific lots of Medex High Pressure Adaptors, Rotators,
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: LogiCal Left Heart Kit
The Issue: Specific lots of Medex High Pressure Adaptors, Rotators,
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: AM12M Acquisition Module accessory. Impacted software version of the AM12M
The Issue: Devices do not meet IEC 60601-2-27 requirements as
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Manifold rotator (Component): a. 250 2 GANG MANIFOLD ROTATOR
The Issue: Specific lots of Medex High Pressure Adaptors, Rotators,
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Surveyor S12/S19 Bedside Patient Monitor
The Issue: Devices do not meet IEC 60601-2-27 requirements as
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Gang Cath Lab Set
The Issue: Specific lots of Medex High Pressure Adaptors, Rotators,
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.