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 8081–8100 of 38,428 recalls
Recalled Item: Venous Hardshell Cardiotomy Reservoir
The Issue: Product packaging may exhibit small pinholes which may
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: QUADROX-iR
The Issue: Product packaging may exhibit small pinholes which may
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: BEQ-HMO 71000-USA /QUADROX-i Adult
The Issue: 1. An accessory may be improperly placed during
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: HMOD 70000-USA/QUADROX-iD Adult
The Issue: 1. An accessory may be improperly placed during
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Access Hybritech p2PSA reagent
The Issue: Reagent lot numbers include an insufficient concentration of
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Aeris Balloon Dilation Catheter
The Issue: Mislabeling
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Aptio Automation Storage and Retrieval Module (SRM)
The Issue: A firmware error may lead to an incorrect
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Draeger Softbed Resuscitaire and/or Birthing Room Warmer with Scale [Model(s):
The Issue: The Resuscitaire Infant Radiant Warmer with the optional
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: HeartWare Ventricular Assist Device System. a) Monitor 1521US Explore Tech
The Issue: Medtronic has identified that the logfiles downloaded from
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Always-On Tip Tracked Instruments (SPiN Drive instruments) Triple Needle Brush
The Issue: Electromagnetic (EM) sensor tracking malfunction impacts the use
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Custom Sterile and Non-Sterile Procedural Kits containing Turkuaz Ultrasound...
The Issue: for the labeled sterile ultrasound gel component
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Custom Sterile and Non-Sterile Procedural Kits containing Turkuaz Ultrasound...
The Issue: for the labeled sterile ultrasound gel component
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Custom Sterile and Non-Sterile Procedural Kits containing Turkuaz Ultrasound...
The Issue: for the labeled sterile ultrasound gel component
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Custom Sterile and Non-Sterile Procedural Kits containing Turkuaz Ultrasound...
The Issue: for the labeled sterile ultrasound gel component
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Custom Sterile and Non-Sterile Procedural Kits containing Turkuaz Ultrasound...
The Issue: for the labeled sterile ultrasound gel component
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Custom Sterile and Non-Sterile Procedural Kits containing Turkuaz Ultrasound...
The Issue: for the labeled sterile ultrasound gel component
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Always-On Tip Tracked Instruments (SPiN Drive instruments) Forceps
The Issue: Electromagnetic (EM) sensor tracking malfunction impacts the use
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Always-On Tip Tracked Instruments (SPiN Drive¿ instruments) Brush
The Issue: Electromagnetic (EM) sensor tracking malfunction impacts the use
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Always-On Tip Tracked Instruments (SPiN Drive instruments) Forceps
The Issue: Electromagnetic (EM) sensor tracking malfunction impacts the use
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Custom Sterile and Non-Sterile Procedural Kits containing Turkuaz Ultrasound...
The Issue: for the labeled sterile ultrasound gel component
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.