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 3361–3380 of 38,428 recalls
Recalled Item: Philips Allura Xper Systems (R7.6-R8.1). Labeled as the following: 1.
The Issue: safety issues in Allura Xper R7.6- R8.1
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: TriALTIS TORQUE LIMITER
The Issue: An out of specification component may result in
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Cardinal Health Presource Kits: 1) KIT
The Issue: for endotoxin contamination in non-sterile surgical strips
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Cardinal Health Presource Kits: 1) KIT
The Issue: for endotoxin contamination in non-sterile surgical strips
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Cardinal Health Presource Kits: 1) UROLOGY ROBOTIC PACK
The Issue: for endotoxin contamination in non-sterile surgical strips
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Cardinal Health Presource Kits: 1) LARYNGOSCOPY PACK
The Issue: for endotoxin contamination in non-sterile surgical strips
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Cardinal Health Presource Kits: 1) KIT
The Issue: for endotoxin contamination in non-sterile surgical strips
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Cardinal Health Presource Kits: 1) KIT
The Issue: for endotoxin contamination in non-sterile surgical strips
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Cardinal Health Presource Kits: 1) KIT
The Issue: for endotoxin contamination in non-sterile surgical strips
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Cardinal Health Presource Kits: 1) KIT
The Issue: for endotoxin contamination in non-sterile surgical strips
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Cardinal Health Presource Kits: 1) ACDF PACK
The Issue: for endotoxin contamination in non-sterile surgical strips
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Cardinal Health Presource Kits: 1) CHI STD SPINE OPTION 1
The Issue: for endotoxin contamination in non-sterile surgical strips
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Cardinal Health Presource Kits: 1) CHI STD NEURO CRANI OPT 1
The Issue: for endotoxin contamination in non-sterile surgical strips
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Cardinal Health Presource Kits: 1) OPHTHALMOLOGY ENDO DCR XTRS PK
The Issue: for endotoxin contamination in non-sterile surgical strips
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Cardinal Health Presource Kits: 1 ) ANEURYSM PACK
The Issue: endotoxin contamination in non-sterile surgical strips and
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Cardinal Health Presource Kits: 1) KIT
The Issue: endotoxin contamination in non-sterile surgical strips and
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Cardinal Health Presource Kits: 1 ) KIT
The Issue: endotoxin contamination in non-sterile surgical strips and
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Cardinal Health Presource Kits: 1) CRANIOTOMY PACK
The Issue: endotoxin contamination in non-sterile surgical strips and
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Cardinal Health Presource Kits: 1) ORTHO PLASTIC MICROVASCULAR PK
The Issue: endotoxin contamination in non-sterile surgical strips and
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Cardinal Health Presource Kits: 1) KIT
The Issue: endotoxin contamination in non-sterile surgical strips and
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.