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 27281–27300 of 38,428 recalls
Recalled Item: Volt Resistance Heated Therapy Shoulder Wrap Deep penetrating heat garment
The Issue: During an FDA inspection it was found that
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Volt Resistance Heated Elbow Garment Deep penetrating heat garment and wraps
The Issue: During an FDA inspection it was found that
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Volt Resistance Heated Neck Garment Deep penetrating heat garment and wraps
The Issue: During an FDA inspection it was found that
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Volt Resistance Heated Therapy Foot Wrap Deep penetrating heat garment
The Issue: During an FDA inspection it was found that
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Volt Resistance Heated Lower Back Garment Deep penetrating heat garment
The Issue: During an FDA inspection it was found that
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: IG1
The Issue: 24 minutes of incubation is required prior to
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Ziehm Vision RFD
The Issue: Malfunction of the radiation-warning timer and the 3D-specific
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: VIDAS NT-pro-BNP Product Usage: VIDAS¿ NTproBNP (PBNP) is an automated
The Issue: Due to a packaging error; The kit does
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Ziehm Vision2
The Issue: Malfunction of the radiation-warning timer and the 3D-specific
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Ziehm Solo
The Issue: Malfunction of the radiation-warning timer and the 3D-specific
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Ziehm Vision R
The Issue: Malfunction of the radiation-warning timer and the 3D-specific
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Ziehm Vision RFD 3D Mobile C-arm for Mobile Fluoroscopic Imaging
The Issue: Malfunction of the radiation-warning timer and the 3D-specific
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Neff DAgostino Percutaneous Access Set Accessories
The Issue: Increase in reports of polymer degradation of the
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Ziehm Vision RFD Mot
The Issue: Malfunction of the radiation-warning timer and the 3D-specific
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Aprima Access Nonvascular Introducer Set Accessories
The Issue: Increase in reports of polymer degradation of the
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Shuttle Select Slip-Cath Catheter
The Issue: Increase in reports of polymer degradation of the
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Beacon Tip Royal Flush Plus High-Flow Catheter Catheter
The Issue: Increase in reports of polymer degradation of the
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: FluoroSet Radiographic Tubal Assessment Set Cannula
The Issue: Increase in reports of polymer degradation of the
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Beacon Tip Torcon NB Advantage Catheter Catheter
The Issue: Increase in reports of polymer degradation of the
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Kumpe Access Catheter Cathether
The Issue: Increase in reports of polymer degradation of the
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.