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 29421–29440 of 38,428 recalls
Recalled Item: MAHURKAR"* 12Fr High Pressure Triple Lumen Acute Dialysis Catheter
The Issue: Sterility may be compromised
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: MAHURKAR 12Fr High Pressure Triple Lumen Acute Dialysis Catheter
The Issue: Sterility may be compromised
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Mahurkar Elite Acute Dual Lumen Catheter Tray
The Issue: Sterility may be compromised
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Mahurkar Elite Acute Triple Lumen Catheter Tray
The Issue: Sterility may be compromised
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Mahurkar Elite Acute Dual Lumen Catheter Tray
The Issue: Sterility may be compromised
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Mahurkar" Elite Acute Dual Lumen Catheter Tray
The Issue: Sterility may be compromised
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Mahurkar Acute Dual Lumen Catheter Tray
The Issue: Sterility may be compromised
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Salto Talaris Tibial Guide
The Issue: Tornier has initiated a voluntary recall for the
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: SurFlo IV Catheter
The Issue: According to the Terumo (TMC) this device is
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Owandy Radiology I -MAX Touch 3D X-ray
The Issue: It has been discovered that due to lack
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Villa Sistemi Rotograph EVO 3D X-ray
The Issue: It has been discovered that due to lack
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Natus neoBLUE 3 Phototherapy system or Neonatal Phototherapy
The Issue: The neoBLUE Instruction For Use (IFU) and Service
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: ARTISTE
The Issue: A software fix has been released to prevent
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: The Leica ASP200S/ASP300S Tissue Processor. Pathology and Hematology...
The Issue: The Leica ASP200S/ASP300S Tissue Processor have an incorrect
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Biomet Parsippany
The Issue: Mislabeling
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: ExacTrac 6.0.x Patient Positioning System
The Issue: ExacTrac 6.0 Patient Positioning System: Display of potentially
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: PROFEMUR PLUS CoCr MODULAR NECK
The Issue: Unexpected rate of postoperative fractures resulting in the
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Angiographic Injector. Medrad Mark 7 Arterion Injection System
The Issue: Software Version SW 005.006_SH, resulted in the removal
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: NebuTech Nebulizer
The Issue: The Inspiratory valve cap on the nebulizer reservoir
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Ferno iNX Wheeled Stretcher
The Issue: Hole elongation in the telescoping load frame channel
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.