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 24681–24700 of 38,428 recalls
Recalled Item: STAPLER
The Issue: Intuitive Surgical has become aware and further investigation
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: STAPLER
The Issue: Intuitive Surgical has become aware and further investigation
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: STAPLER
The Issue: Intuitive Surgical has become aware and further investigation
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: STAPLER
The Issue: Intuitive Surgical has become aware and further investigation
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Nexstim eXima NBS System Software version 2.2 or higher. The
The Issue: Software defect: the NBS software may accidentally generate
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: NBS System 4 (sw version 4.0 or higher)
The Issue: Software defect: the NBS software may accidentally generate
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Pausch Uroview FD fluoroscopic X-ray system UDI number (01)04260491620040...
The Issue: During patient interventions with the urology table the
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Accu-Chek Connect Diabetes Management App versions 2.0.0
The Issue: A program error (bug) in the Bolus Advisor
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Accelerate Pheno system
The Issue: Rare isolates of Enterobacteriaceae may generate a susceptible
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Measurement Specialties Reusable Temperature Probe Autoclavable. Sold as...
The Issue: The reusable temperature probes are provided with instructions
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Small Particle Aerosol Generator Model SPAG-2 6000 Series (SPAG-2). The
The Issue: SPAG-2 unit nebulizers from Lot J0571670RA were tested
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: NEODENT CM Intraoral Scanbody
The Issue: During internal testing, Neodent determined that the body
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Bedside monitor CSM-1901(Life Scope G9) with main unit CU-192RA. The
The Issue: The Pause function on central monitors will not
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Stryker PROFESS Registration Kit. The Stryker PROFESS Registration Kit is
The Issue: Product shipped proximate to or past the expiration
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: HeartWare Ventricular Assist System (HVAD) Pump Driveline Splice Kit Product
The Issue: In April 2015, HeartWare, now a part of
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Access Ferritin Calibrators
The Issue: Beckman Coulter is recalling the Access Ferritin Calibrators
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Vivid S60/S70/S60N/S70N
The Issue: GE Healthcare has become aware of an issue
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Vivid E95/E90/E80
The Issue: GE Healthcare has become aware of an issue
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: D-RAD
The Issue: The expiration dates on the labeling are incorrect,
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Peri-Loc(R) VLP 3.5 MM X 6 MM SELF-TAPPING CORTEX SCREW
The Issue: The expiration dates on the labeling are incorrect,
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.