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 36461–36480 of 38,428 recalls
Recalled Item: LPS Diaphyseal Sleeves Product Usage: The LPS Diaphyseal Sleeves are
The Issue: DePuy Orthopaedics is initiating a voluntary recall of
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Animas(R) 2020 Insulin Infusion Pump Product Usage: This product is
The Issue: Animas has identified a component issue affecting a
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: TUNNELOC ROUND HEAD INTERFERENCE SCREW 8MMX25MM Biomet Sports Medicine...
The Issue: Thru hole at the tip of the screw
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: The Lumenis VersaCut Tissue Morcellator Product Usage: is intended for
The Issue: Lumenis Ltd is recalling certain models of VersaCut
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Diagnostic Hybrids
The Issue: RhMK product fungal contamination
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: CELLTRACKS AUTOPREP System (Software Version 2.4.1 & Below. Product Usage:
The Issue: Veridex, LLC has received a report that a
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: CELLTRACKS ANALYZER II (Software Version 2.5.1 & Below. Product Usage:
The Issue: Veridex, LLC has received a report that a
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Creatinine
The Issue: Beckman Coulter is including additional information and instructions
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Heartware HVAD Pump Implant Kit (Heartware Ventricular Assist Device)
The Issue: HeartWare, Inc. of Miami Lakes, FL is recalling
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Stryker XIA 3 Iliac Screwdriver
The Issue: Surgeons have experienced unthreading of the screwdrivers outer
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Goldvac(TM) UltraClean(R) Accessory Electrode 1 inch Coated Blade with Extended
The Issue: ConMed received complaints of some devices which had
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: UltraClean(R) Accessory Electrode 6 inch Coated Needle with Extended Insulation
The Issue: ConMed received complaints of some devices which had
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: UltraClean(R) Accessory Electrode 6 inch Coated Blade with Extended Insulation
The Issue: ConMed received complaints of some devices which had
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: UltraClean(R) Accessory Electrode 4 inch Coated Blade
The Issue: ConMed received complaints of some devices which had
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: UltraClean(R) Accessory Electrode 1 inch Coated Needle
The Issue: ConMed received complaints of some devices which had
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Goldvac(TM) UltraClean(R) Accessory Electrode 4 inch Coated Blade
The Issue: ConMed received complaints of some devices which had
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: UltraClean(R) Accessory Electrode 1 inch Coated Blade with Extended Insulation
The Issue: ConMed received complaints of some devices which had
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Goldvac(TM) UltraClean(R) Accessory Electrode 6 inch Coated Blade with Extended
The Issue: ConMed received complaints of some devices which had
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: UltraClean(R) Accessory Electrode 4 inch Coated Blade with Extended Insulation
The Issue: ConMed received complaints of some devices which had
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: ELECTROSURGICAL ENT NEEDLE ELECTRODE
The Issue: ConMed received complaints of some devices which had
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.