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 8121–8140 of 38,428 recalls
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) SPiN Xtend 2.0mm OD
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: Always-On Tip Tracked Instruments (SPiN Drive instruments) 19ga ANSO Histology
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: OEC 9900 Systems with 9-inch Image Intensifier
The Issue: Image intensifiers on systems, used to provide fluoroscopic/digital
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) 22ga SPiN Flex Needle
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.