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 6001–6020 of 38,428 recalls
Recalled Item: Abre Venous Self-expanding Stent System
The Issue: There is a potential for sterile package breach
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: CARTO VIZIGO Bi-Directional Guiding Sheath
The Issue: Due to a manufacturing issue, device under process
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Augustine Surgical Inc. HotDog Return Electrode accessory connector cables
The Issue: Users were experiencing the following error message (M-0B-125)
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Augustine Surgical Inc. HotDog Return Electrode accessory connector cables
The Issue: Users were experiencing the following error message (M-0B-125)
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: DIVA 24 Inch Widescreen LCD Touch Display - Used with
The Issue: If the DIVA touch display generates touch inputs
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Mariner RDX Polyaxial Head
The Issue: Screw heads, of pedicle screw systems, have thin
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Masimo Rad-G
The Issue: Their is a potential that Oximeter may automatically
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Masimo Rad-G
The Issue: Their is a potential that Oximeter may automatically
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Masimo Rad-G
The Issue: Their is a potential that Oximeter may automatically
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Masimo Rad-G
The Issue: Their is a potential that Oximeter may automatically
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Bio-Rad
The Issue: Due to incorrect calibrations and controls, their is
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Signia" Small Diameter Curved Tip Intelligent Reload
The Issue: Under certain firing conditions, reloads were found to
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Covidien Signia" Small Diameter Curved Tip Intelligent Reload
The Issue: Under certain firing conditions, reloads were found to
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Cystatin C Calibrator - In vitro diagnostic (IVD) use in
The Issue: Cystatin C Calibrator Series CVS 2699, is running
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: STERIS Boot Assembly
The Issue: Three lots of the Boot Assembly, Traction Device
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: HeartSine samaritan PAD (Public Access Defibrillator): Type/Catalog: SAM...
The Issue: Automated external defibrillators were shipped in their test
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: GeoMed Custom Tracecarts
The Issue: DeRoyal manufactured and distributed Surgical Tracecarts that contain
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Boston Scientific POLARSHEATH Steerable Sheath 12F
The Issue: Boston Scientific has identified a tooling error in
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Curaplex Nasal Intubation Kit w/ 7mm Endotracheal Tube-To perform a
The Issue: Endotracheal Tube Holder included in certain kits is
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: ARROW QuickFlash Radial Artery Catherization (wire
The Issue: Teleflex is initiating this voluntary recall for the
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.