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 4901–4920 of 38,428 recalls
Recalled Item: Stimuplex A
The Issue: The devices are labeled "not made with DEHP"
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Stimuplex A
The Issue: The devices are labeled "not made with DEHP"
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: TourniKwik Tourniquet Set (CFN 79012)
The Issue: Incorrect component placed in four manufactured lots of
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: BIOFIRE FILMARRAY Gastrointestinal (GI) Panel (30 test kit)
The Issue: Due to increase of false positive Vibrio/Vibrio Cholerae
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Abbott Proclaim XR 5 Implantable Pulse Generator
The Issue: The duration between the implantable pulse generator reaching
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Abbott Proclaim 5 Implantable Pulse Generator
The Issue: The duration between the implantable pulse generator reaching
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Abbott Proclaim 7 Implantable Pulse Generator
The Issue: The duration between the implantable pulse generator reaching
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Abbott Proclaim XR 7 Implantable Pulse Generator
The Issue: The duration between the implantable pulse generator reaching
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Abbott Proclaim Plus 7 Implantable Pulse Generator
The Issue: The duration between the implantable pulse generator reaching
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Abbott Proclaim Plus 5 Implantable Pulse Generator
The Issue: The duration between the implantable pulse generator reaching
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Abbott Proclaim DRG Implantable Pulse Generator
The Issue: The duration between the implantable pulse generator reaching
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Abbott Proclaim Plus 5 Implantable Pulse Generator
The Issue: The duration between the implantable pulse generator reaching
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Abbott Proclaim 5 Implantable Pulse Generator
The Issue: The duration between the implantable pulse generator reaching
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Proclaim 7 Elite Implantable Pulse Generator
The Issue: The duration between the implantable pulse generator reaching
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Abbott Proclaim 7 Implantable Pulse Generator
The Issue: The duration between the implantable pulse generator reaching
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Proclaim 5 Elite Implantable Pulse Generator
The Issue: The duration between the implantable pulse generator reaching
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Abbott Liberta RC
The Issue: Deep brain stimulation system will first turn off
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Inspire Model 3028
The Issue: There is a potential manufacturing defect which can
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: US AquaA 900H-Typ USA-3 x 208v-Intended for the purification of
The Issue: Concentrate Flow was exceeding the maximum 19.9 bar
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Philips Allura Xper FD10 system with an ADN7NT patient table.
The Issue: When Software upgrade 8.1.100 is installed on an
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.