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 33901–33920 of 38,428 recalls
Recalled Item: Simplexa Flu AlB & RSV Direct Assay Kits
The Issue: Focus Diagnostics initiated the recall of the certain
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Optiflux F200NR High Flux Dialyzers
The Issue: Dialysate Port Leak During Priming of the Dialyzers
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Optiflux F18Nre Flux Dialyzers
The Issue: Dialysate Port Leak During Priming of the Dialyzers
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Optiflux F200NRe High Flux Dialyzers
The Issue: Dialysate Port Leak During Priming of the Dialyzers
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Optiflux B200 Flux Dialyzers
The Issue: Dialysate Port Leak During Priming of the Dialyzers
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Optiflux F160NRe High Flux Dialyzers
The Issue: Dialysate Port Leak During Priming of the Dialyzers
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Philips HeartStart MRx Monitor/Defibrillator used Model numbers: M3535A
The Issue: HeartStart MRx Defibrillator Monitor therapy connection could experience
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Optiflux F160NR High Flux Dialyzers
The Issue: Dialysate Port Leak During Priming of the Dialyzers
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Optiflux F180NR High Flux Dialyzers
The Issue: Dialysate Port Leak During Priming of the Dialyzers
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Optiflux F200A High Flux Dialyzers
The Issue: Dialysate Port Leak During Priming of the Dialyzers
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Optiflux F180NRe High Flux Dialyzers
The Issue: Dialysate Port Leak During Priming of the Dialyzers
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Boston Scientific
The Issue: Boston Scientific is initiating this Recall Removal of
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Boston Scientific
The Issue: Boston Scientific is initiating this Recall Removal of
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: OneTray Sealed Sterilization Containers Product Usage: A rigid sterilization...
The Issue: The wrong sterilization time was on the label
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: The GemStar Power Supply is an accessory for the GemStar
The Issue: The GemStar Infusion pump may not receive direct
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: The GemStar Power Supply is an accessory for the GemStar
The Issue: The GemStar Infusion pump may not receive direct
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Hot Ice
The Issue: Firm is not registered as a drug manufacturer
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Nice-En-Smooth Berry Burst
The Issue: Firm is not registered as a drug manufacturer
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Amo-O Herbal Stimulator
The Issue: Firm is not registered as a drug manufacturer
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Mega-Gen His Personal Lubricant
The Issue: Firm is not registered as a drug manufacturer
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.