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 10361–10380 of 38,428 recalls
Recalled Item: Hemoglobin A1c for use with Architect
The Issue: There is a potential for falsely elevated Hemoglobin
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item:
The Issue: There is a potential for falsely elevated Hemoglobin
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Soluble Transferrin Receptors (STFR)
The Issue: A customer reported a problem with the reagent
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Soluble Transferrin Receptors Calibrator Series (STFR CAL)
The Issue: A customer reported a problem with the reagent
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: CoolMax ZELTIQ Vacuum Applicator
The Issue: Executing a voluntary discontinuation and removal of parallel
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: CoolFit ZELTIQ Vacuum Applicator
The Issue: Executing a voluntary discontinuation and removal of parallel
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: CoolCurve ZELTIQ Vaccum Applicator
The Issue: Executing a voluntary discontinuation and removal of parallel
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: CoolCurve+ ZELTIQ Vacuum Applicator
The Issue: Executing a voluntary discontinuation and removal of parallel
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Alcon Custom Pak Surgical Procedure Pack: 16998-11 2519351H SALAHUDDIN 2.4
The Issue: Due to latex gloves being include in Custom
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: CoolCore ZELTIQ Vacuum Applicator
The Issue: Executing a voluntary discontinuation and removal of parallel
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Abbott TactiCath Sensor Enabled
The Issue: When connected to the EnSite Precision Navigation System,
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Palindrome HSI Chronic Catheter
The Issue: There is a potential leaking condition within the
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: GE Centricity Universal Viewer Zero Footprint. To view
The Issue: to display inaccurate measurements on images in
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Palindrome Precision Chronic Catheter
The Issue: There is a potential leaking condition within the
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Palindrome Precision HSI Chronic Catheter
The Issue: There is a potential leaking condition within the
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Palindrome H Chronic Catheter
The Issue: There is a potential leaking condition within the
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Palindrome SI Chronic Catheter
The Issue: There is a potential leaking condition within the
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Mahurkar Chronic Carbothane (Maxid) Catheter
The Issue: There is a potential leaking condition within the
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Palindrome Chronic Catheter
The Issue: There is a potential leaking condition within the
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Palindrome Precision H Chronic Catheter
The Issue: There is a potential leaking condition within the
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.