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 10841–10860 of 38,428 recalls
Recalled Item: ADVIA Centaur Enhanced Estradiol (eE2) 500T - In vitro diagnostic
The Issue: Falsely Elevated Results Observed with Plasma Specimens, could
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: ADVIA Centaur Enhanced Estradiol (eE2) (REF) 500T - In vitro
The Issue: Falsely Elevated Results Observed with Plasma Specimens, could
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Atellica IM Enhanced Estradiol (eE2) (REF) 500T - In vitro
The Issue: Falsely Elevated Results Observed with Plasma Specimens, could
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Atellica IM Enhanced Estradiol (eE2) 500T - In vitro diagnostic
The Issue: Falsely Elevated Results Observed with Plasma Specimens, could
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: ADVIA Centaur Enhanced Estradiol (eE2) 100T - In vitro diagnostic
The Issue: Falsely Elevated Results Observed with Plasma Specimens, could
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Atellica IM Enhanced Estradiol (eE2) 100T - In vitro diagnostic
The Issue: Falsely Elevated Results Observed with Plasma Specimens, could
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: DeRoyal ST Neonatal Dressing Change Kit
The Issue: A kit component, the PDI Prevantics Swab was
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: DeRoyal Ultra/Mammo Tray
The Issue: A kit component, the PDI Prevantics Swab was
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: DeRoyal DEXMED ACCESS CENTER TRAY
The Issue: A kit component, the PDI Prevantics Swab was
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Pneumonia (33 Targets) Control Panel
The Issue: Shelf-life for the 8244 Pneumonia (33 Targets) Control
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: First Aid Kits containing acetaminophen under brand names Equate (Walmart)
The Issue: Kits contained recalled acetaminophen
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Harmony Delivery Catheter System. Part of the Harmony Transcatheter Pulmonary
The Issue: There is potential for the capsule bond to
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: AccessPLUS Large Bore Hemostasis Valves
The Issue: A design change made to a hemostasis valve
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Access-9 Large Bore Hemostasis Valves
The Issue: A design change made to a hemostasis valve
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: FORE-SIGHT ELITE Absolute Tissue Oximeter
The Issue: The StO2 values may be inaccurately low when
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: FORE-SIGHT ELITE Tissue Oximeter module
The Issue: The StO2 values may be inaccurately low when
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: NanoSight LM10 fitted with LM12 module. A laboratory instrument for
The Issue: Product found to not comply to Class 1
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: NanoSight LM10 fitted with LM14 module. A laboratory instrument for
The Issue: Product found to not comply to Class 1
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: MEDTRONIC INTERSTIM THERAPY SYSTEM FOR URINARY CONTROL
The Issue: There is a software anomaly with the InterStim
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Philips Respironics V680 Ventilator (All Models
The Issue: Ventilator units have an issue impacting an internal
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.