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 7101–7120 of 38,428 recalls
Recalled Item: Transnasal esophagovideoscope-For endoscopy and endoscopic surgery within...
The Issue: Channel air drying process was not validated, and
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Cystonephroscope-endoscopic diagnosis and treatment within the bladder
The Issue: Channel air drying process was not validated, and
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Tracheal videoscope- For airway management
The Issue: Channel air drying process was not validated, and
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Hysterovideoscope-For endoscopic diagnosis within the uterus Model Number:...
The Issue: Channel air drying process was not validated, and
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Gastrointestinal videoscope-indicated for use within the upper digestive...
The Issue: Channel air drying process was not validated, and
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Duodenovideoscope-EndoTherapy accessories (such as a biopsy forceps)
The Issue: Channel air drying process was not validated, and
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Hysterofiberscope-For endoscopic diagnosis within the uterus. Model Number:...
The Issue: Channel air drying process was not validated, and
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Small intestinal videoscope-For endoscopy and endoscopic surgery within the...
The Issue: Channel air drying process was not validated, and
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Colonoscope: for endoscopy and endoscopic surgery within the lower digestive
The Issue: Channel air drying process was not validated, and
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Ultrasonic gastrovideoscope-Real time ultrasound imaging
The Issue: Channel air drying process was not validated, and
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Mobile airway scope-diagnosis and observation to access airway anatomy
The Issue: Channel air drying process was not validated, and
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Hysteroscope-For endoscopic diagnosis within the uterus Model Number: HYF-1T.
The Issue: Channel air drying process was not validated, and
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Uretero-reno fiberscope-For endoscopic diagnosis and treatment within the...
The Issue: Channel air drying process was not validated, and
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Arial Water Resistant Pendant with Long Wristband
The Issue: Premature battery depletion presents a risk that alarms
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: RSP Humeral Socket Insert Size 36mm Semi-Constrained +4 mm
The Issue: Two different humeral socket Insert devices were swapped
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Arial Water Resistant Pendant with Wristband
The Issue: Premature battery depletion presents a risk that alarms
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Arial Water Resistant Pendant with Neck Lanyard
The Issue: Premature battery depletion presents a risk that alarms
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: RSP Humeral Small Socket Insert Size 32 mm Semi-Constrained +4
The Issue: Two different humeral socket Insert devices were swapped
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: SPRYSTEP VECTOR KAFO
The Issue: Due to potential air pockets between layers of
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: CUSTOM SPRYSTEP
The Issue: Due to potential air pockets between layers of
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.