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 27641–27660 of 38,428 recalls
Recalled Item: cobas¿ EGFR Mutation Test
The Issue: An error was found within the Hungarian translations
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Boston Scientific TSX Transseptal Needle
The Issue: Merit Medical Systems, Inc. is voluntarily conducting a
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: GE Healthcare
The Issue: The vacuum suction tubing could be kinked within
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: MEVION S250 for Proton Radiation Therapy
The Issue: Possibility of Gantry Motion with Aperture or Compensator
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Xcela PICC with PASV Valve Technology
The Issue: PICC catheters that contain valve(s) manufactured prior to
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Vaxcel PICC with PASV Catheter Kit under the following labels: 1) 3F
The Issue: PICC catheters that contain valve(s) manufactured prior to
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Vaxcel PICC with PASV Introducer Kit under the following labels: 1) 4F
The Issue: PICC catheters that contain valve(s) manufactured prior to
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: BioFlo PICC with ENDEXO and PASV Valve Technology
The Issue: PICC catheters that contain valve(s) manufactured prior to
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Xcela PICC with PASV Valve Technology Catheter Kit
The Issue: PICC catheters that contain valve(s) manufactured prior to
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: BioFlo PICC with ENDEXO and PASV Valve Technology
The Issue: PICC catheters that contain valve(s) manufactured prior to
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Vaxcel PICC with PASV MST-60 Kit under the following labels: 1) 3F
The Issue: PICC catheters that contain valve(s) manufactured prior to
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Vaxcel PICC with PASV Intermediate Safety MST Kit under the
The Issue: PICC catheters that contain valve(s) manufactured prior to
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: BioFlo Hybrid PICC with ENDEXO and PASV Valve Technology
The Issue: PICC catheters that contain valve(s) manufactured prior to
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Xcela PICC with PASV Valve Technology
The Issue: PICC catheters that contain valve(s) manufactured prior to
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Xcela Hybrid PICC with PASV Valve Technology
The Issue: PICC catheters that contain valve(s) manufactured prior to
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: BioFlo PICC with ENDEXO and PASV Valve Technology
The Issue: PICC catheters that contain valve(s) manufactured prior to
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Xcela Hybrid PICC with PASV Valve Technology
The Issue: PICC catheters that contain valve(s) manufactured prior to
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Vaxcel PICC with PASV IR-145 Kit under the following labels: 1) 4F
The Issue: PICC catheters that contain valve(s) manufactured prior to
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Xcela Hybrid PICC with PASV Valve Technology
The Issue: PICC catheters that contain valve(s) manufactured prior to
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: BioFlo Hybrid PICC with ENDEXO and PASV Valve Technology
The Issue: PICC catheters that contain valve(s) manufactured prior to
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.