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 921–940 of 38,428 recalls
Recalled Item: MAHURKAR" Acute High Pressure Triple Lumen Catheter Tray Curved Extensions
The Issue: A potential issue with the seal integrity of
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: MAHURKAR" Acute High Pressure Triple Lumen Catheter Tray Curved Extensions
The Issue: A potential issue with the seal integrity of
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: MAHURKAR" Acute High Pressure Triple Lumen Catheter Tray Straight Extensions
The Issue: A potential issue with the seal integrity of
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: MAHURKAR" Acute High Pressure Triple Lumen Catheter Tray Straight Extensions
The Issue: A potential issue with the seal integrity of
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Ceiling Type X-Ray Tube Support Models CH-200 and CH-200M used with RADspeed
The Issue: Due to an issue (potential breakage) with the
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: VANTAGE GALAN 3T. CMSC Model: MRT-3020/U7. Model Number: MEXL-3020/B7.
The Issue: Affected system contains components that do not meet
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: BECKMAN COULTER BICARBONATE OSR6237 OSR6637 OSR6x37 Bicarbonate is
The Issue: Bicarbonate reagent may generate falsely high Bicarbonate results
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: EVIS EXERA III Duodenovideoscope Product Name: Olympus TJF-Q190V
The Issue: Continued reports of positive cultures and infections have
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: BD Luer Tip Caps
The Issue: BD has confirmed through internal testing that certain
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: MRI LED Mobile Exam Light Battery This non-magnetic
The Issue: Due to battery component overheating while charging resulting
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Phantom Fibula Nail
The Issue: Fibula nail system intended for use in fixation
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: DermaSensor. Model/Catalog Number: 10101. Software Version: 3.0.2....
The Issue: for device to not meet specifications resulting
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: TMJ Bilateral Implant Sterile EO
The Issue: Patient-fitted temporomandibular joint implant contained discrepancy in screw
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: CentriMag Blood Pump
The Issue: Acute circulatory support system pump may not fit
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Anesthesia Circuit Kits and other various kits that contain Anesthesia Circuits
The Issue: Firm received multiple complaints of anesthesia circuit leaks
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Anesthesia Circuit Kits and other various kits that contain Anesthesia Circuits
The Issue: Firm received multiple complaints of anesthesia circuit leaks
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: DYNJ909119G ROBOTIC GASTRIC LAP SLEEVE-LF DYNJ909127F CYSTO DYNJ909129D...
The Issue: Firm received multiple complaints of anesthesia circuit leaks
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Anesthesia Circuit Kits and other various kits that contain Anesthesia Circuits
The Issue: Firm received multiple complaints of anesthesia circuit leaks
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Convenience Kit
The Issue: Firm received multiple complaints of anesthesia circuit leaks
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Convenience kits
The Issue: Firm received multiple complaints of anesthesia circuit leaks
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.