Early Alert: Sizing Catheter Issue from Cook Medical

Published: 04/09/2026

Sources:
  • Food and Drug Administration
Relevant To:
  • Ambulatory Surgical Centers,
  • Rural Emergency Hospitals,
  • Critical Access Hospitals,
  • Hospitals,
  • Ambulatory Care

The FDA is aware that Cook Medical has issued a letter to affected customers recommending certain sizing catheters be removed from where they are used or sold. The affected devices are:

  • Centimeter Sizing Catheters
  • Aurous Centimeter Sizing Catheters
  • Beacon Tip Centimeter Sizing Catheters

The full list of affected product lots can be found here.

Cook identified that the marker bands on impacted products may be at an increased risk of cracking/breakage.  

As of April 2, Cook ha…

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