The Recall Desk
HighFDA (Devices)·Z-1871-2025·Announced 2025-06-04

Cardinal Health Umbilical Vessel Catheter Recall for Sterility Defect

Cardinal Health is recalling 1,710 units of Umbilical Vessel Catheter 2.5 French single lumen due to a packaging defect that may compromise sterility. Non-sterile catheters could cause infection in neonates.

What this means for you

Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.

Our severity reasoning: This is an FDA Class II medical device recall involving a high-risk scenario (potential infection in neonates from non-sterile product). The source explicitly states the potential harm (infection) but does not report any actual illnesses or injuries, placing it at the high end of Class II / High severity per the rubric.

Plain-English summary

Cardinal Health 200, LLC is recalling Catalog No. 8888160325 Umbilical Vessel Catheter 2.5 French single lumen. The recall affects 1,710 units distributed nationwide across all U.S. states and to Brazil, Canada, Chile, Colombia, Singapore, and South Africa.

A packaging defect may compromise the sterility of the product. If a non-sterile catheter is used on a patient, it could lead to infection in neonates. Affected lot numbers are 2433100060, 2433100059, 2422700145, 2422700139, 2422700146, and 2422700142.

If you have received this product, do not use it. Contact Cardinal Health 200, LLC or the FDA for instructions on how to handle your inventory.

The recalled product

Product
Catalog No. 8888160325; Umbilical Vessel Catheter 2.5 French single lumen
Manufacturer
Cardinal Health 200, LLC
Category
Medical Device — Umbilical Catheter
Hazard
  • sterility-defect
  • infection-risk

Is your product affected?

Check your packaging against the codes below. If any of them match, the product is part of this recall.

Lot numbers (1)

  • UDI-DI (ea) 10192253040296

Distribution

Distributed nationwide across the United States.

Related recalls

Same category