The Recall Desk
ModerateFDA (Devices)·Z-1995-2025·Announced 2025-07-02

Medline Umbilical Tray sterile packaging defect recall

Medline is recalling umbilical trays due to a possible packaging defect in the outer Tyvec pouch that protects the sterile product. The defect may compromise sterility.

What this means for you

Minor labeling or packaging issue, or a voluntary precautionary recall. Risk of harm is low but real — follow the manufacturer's instructions.

Our severity reasoning: This is an FDA Class II recall. The source text identifies only a possible packaging defect with no reported illnesses or injuries, making it a precautionary recall that does not rise to the level of High severity.

Plain-English summary

Medline Industries, LP is recalling the Medline UMBILICAL TRAY W/3.5&5FR CATH (Reference UVT1250) due to a possible packaging defect impacting the outer Tyvec pouch that protects the sterile product.

The packaging defect may compromise the sterility of the medical device. A total of 174 units have been recalled.

The affected product was distributed nationwide in Virginia. Lot numbers 25BBG881, 24KBU973, 24IBK851, and 24HBQ012 are included in this recall.

Consumers in possession of this product should stop using it and contact Medline Industries or their healthcare provider for further instructions.

The recalled product

Product
Medline UMBILICAL TRAY W/3.5&5FR CATH, REF UVT1250
Manufacturer
MEDLINE INDUSTRIES, LP - Northfield
Category
Medical Device — Umbilical Catheter Tray
Hazard
  • sterility-compromise
  • packaging-defect

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 (6)

  • UDI-DI: 10653160995340 (each)
  • 40653160995341 (case)
  • Lot Numbers: 25BBG881
  • 24KBU973
  • 24IBK851
  • 24HBQ012

Distribution

Distributed nationwide across the United States.

Related recalls

Same category