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 36801–36820 of 38,428 recalls
Recalled Item: SenTec V-Sign Membrane Changer (VS-MC)
The Issue: A manufacturing defect was observed for the membrane
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Synthes Trauma Nail System. The devices are indication for bone fixation.
The Issue: Recall was initiated due to the possibility that
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Sterile Rigid Tip Suction Wand The Suction Wands are indicated
The Issue: California Medical Laboratories, Inc. has identified an issue
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Rigid Tip Suction Wand Non sterile bulk devices (S112468N
The Issue: California Medical Laboratories, Inc. has identified an issue
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Maquet Yuno Extension Table Device Maquet GmbH & Co. KG
The Issue: There is a potential issue with the screw
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Brookstone Heated Body Bean
The Issue: Additional Warning Statement to prevent burns to the
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: BleaseFocus Anesthesia Workstation and 700/900 Series Ventilators are...
The Issue: The BleaseFocus Anesthesia Workstation and 700/900 Series Ventilators
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: KING LAD Flexible ClearSeal SINGLE USE
The Issue: The firm received two complaints from a user
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: KING LAD Flexible ClearSeal SINGLE USE
The Issue: The firm received two complaints from a user
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: KING LAD SILI CONE SINGLE USE
The Issue: The firm received two complaints from a user
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: KING LAD Standard ClearSeal SINGLE USE
The Issue: The firm received two complaints from a user
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: KING LAD Standard ClearSeal SINGLE USE
The Issue: The firm received two complaints from a user
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: KING LAD SILI CONE SINGLE USE
The Issue: The firm received two complaints from a user
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: KING LAD SILI CONE SINGLE USE
The Issue: The firm received two complaints from a user
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: KING LAD Standard ClearSeal SINGLE USE
The Issue: The firm received two complaints from a user
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: KING LAD SILI CONE SINGLE USE
The Issue: The firm received two complaints from a user
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: KING LAD Standard ClearSeal SINGLE USE
The Issue: The firm received two complaints from a user
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: CADstream software. Product Usage: CADstream is an image processing system
The Issue: An incorrect biopsy or missed target could result
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: VITROS¿ Immunodiagnostic Products Anti-HBs (total antibody to hepatitis B...
The Issue: Ortho Clinical Diagnostics is recalling certain lots of
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Abbott Point of Care i-Stat cTnI cartridge. The i-Stat cardiac
The Issue: APOC has determined that 10 boxes of i-Stat
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.