FDA identifies, issues Class 1 recalls

Dec 30, 2025 - 01:37 PM
FDA-product-recall

The Food and Drug Administration has identified a recall by Cook Medical of Zenith Alpha 2 Thoracic Endovascular Graft proximal components after Cook Medical found that scrapings of polytetrafluoroethylene coating may be released inside the stent graft during use. Impacted components include all length ZTA2-P/PT devices with diameters between 40 mm and 46 mm. Cook Medical advises customers to determine if the products are in their inventory, stop all distribution and use of the products, and return affected products to Cook Medical.

In addition, the FDA has identified the following recalls:

  • IV Gravity Burette Set from ICU Medical, due to the burette component missing an internal shut-off valve intended to stop fluid flow
  • Codman Microsensor Basic Kits and Cerelink ICP Sensor Basic Kits from Integra LifeSciences
  • Rheumacare Capsules by Virgo UAP Pharma Pvt. Ltd. from Handelnine Global Limited d/b/a Navafresh

The FDA also recognized a system correction for IMPRIS Neuro III-SV by Imaging Inc.

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