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 32821–32840 of 38,428 recalls
Recalled Item: AGFA Digital Radiography X-Ray system DX-D 100 Agfa's DX-D 100
The Issue: When liquid comes in contact with the DX-D
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: The Hospira MedNet Medication Management Suite (MMS). Product Usage: The
The Issue: Hospira MedNet 5.5, 5.8.1, and 5.8.2 contains software
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: BD FACS Canto and associated Fluidics Cart Product Usage: Flow
The Issue: Laser cooling fans and internal fan of the
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Spacelabs Healthcare Qube Compact Monitor
The Issue: Spacelabs Healthcare is recalling Qube Compact Monitor, Model
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: DMI Duro-Med Industries Rollator Transport Chair
The Issue: There have been 5 customer reports of a
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Artis zee and Artis zeego systems. x-ray
The Issue: There is a potential problem with Artis zee
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: UltraStream Chronic Hemodialysis Catheter Standard Kit
The Issue: UltraStream Chronic Hemodialysis Catheter may develop cracks on
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: UltraStream Peel Away Kit
The Issue: UltraStream Chronic Hemodialysis Catheter may develop cracks on
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: UltraStream Exchange Kit Model Numbers 32001524 (24 cm)
The Issue: UltraStream Chronic Hemodialysis Catheter may develop cracks on
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: AXIOM Artis or Artis zee system Product Usage: Axiom Artis
The Issue: There is a potential problem with the AXIOM
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Excelsior Medical Sterile Triple Lead Tubing Set and Sterile Heavy
The Issue: There is a potential for a leak. A
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Calcium Hydroxide Powder
The Issue: One lot of Calcium Hydroxide Powder is being
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Aquapak 640 SW
The Issue: The seals of the adaptor packaging may be
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Humidifier Adaptor
The Issue: The seals of the adaptor packaging may be
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Aquapak 340 SW
The Issue: The seals of the adaptor packaging may be
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Aquapak 640 SW
The Issue: The seals of the adaptor packaging may be
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Aquapak 101 SW
The Issue: The seals of the adaptor packaging may be
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Aquapak 640 SW
The Issue: The seals of the adaptor packaging may be
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Adaptor
The Issue: The seals of the adaptor packaging may be
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Humidifier Adaptor 040
The Issue: The seals of the adaptor packaging may be
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.