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 13281–13300 of 38,428 recalls
Recalled Item: WMTS Telemetry Receiver
The Issue: Incorrect Date Stamp or No Data Transfer on
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: 13C-Spirulina Gastric Emptying Breath Test (GEBT) - Product Usage: intended
The Issue: for false negative diagnosis of gastroparesis. Certain
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Universal Femoral Sleeves - Product Usage: used primarily in revision
The Issue: The taper dimensions may be out of specification
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: The PrisMax System Version II Hemodialysis Delivery System: Automatic...
The Issue: Variability in the performance of the tubing in
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Lab Coats SMS X-Large Blue
The Issue: Foreign Object Contamination
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Kendall Spill Kit
The Issue: Foreign Object Contamination
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Gown Isolation W/Ties Xl Blue
The Issue: Foreign Object Contamination
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Gown Isolation W/Ties Univ Blu
The Issue: Foreign Object Contamination
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: ChemoPlus Drug Spill Kit-INSTI
The Issue: Foreign Object Contamination
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Lab Coats SMS 2X-Large White
The Issue: Foreign Object Contamination
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Covidien ChemoPlus Chemo Spill Kit
The Issue: Foreign Object Contamination
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: ChemoPlus" Chemo Prep & Admin Kit
The Issue: Foreign Object Contamination
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Gown Isolation W/Ties Xl Ylw
The Issue: Foreign Object Contamination
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Lab Coats SMS Large Blue
The Issue: Foreign Object Contamination
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Lab Coats SMS Medium White
The Issue: Foreign Object Contamination
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: CHEMOBLOC Preparation and Administration Kit
The Issue: Foreign Object Contamination
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Gown Kendall Blue RG
The Issue: Foreign Object Contamination
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Lab Coats SMS Large White
The Issue: Foreign Object Contamination
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: CHEMOPLUS DRUG SPILL KIT HOS
The Issue: Foreign Object Contamination
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Gown Isolation W/Ties Univ Ylw
The Issue: Foreign Object Contamination
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.