The Recall Desk
HighFDA (Devices)·Z-1973-2025·Announced 2025-06-18

BD TEXIUM Closed Male Luer Drug Transfer Device Recall

BD TEXIUM Closed Male Luer devices may leak at the interface between the closed male luer component and needle-free connector. The leak could cause procedure delays, treatment interruptions, exposure to hazardous drugs, and underdosing of medication.

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 recall of a medical device with potential for serious harm (exposure to hazardous drugs, underdosing, treatment interruption). The source text does not report any actual illnesses or injuries, making this a risk-of-harm product where injury has not yet been reported, which per the rubric qualifies as High severity.

Plain-English summary

BD TEXIUM Closed Male Luer with Female Cap (REF: 10012241-0500) is a sterile, single-use closed system drug transfer device that may be used standalone or attached to infusion sets or bonded syringes. The affected devices have been distributed nationwide across the United States and internationally to Canada, Australia, New Zealand, and China.

A potential leak may occur at the interface between the closed male luer component and the needle-free connector. This leak could result in procedure delays, treatment interruptions, exposure to hazardous drugs, and underdosing of medication.

Approximately 1,655,300 units have been recalled. Multiple lot numbers are affected with expiration dates ranging from March 2026 through December 2027. Affected healthcare facilities and providers should identify any remaining units of this product and assess for potential leaks before use. Consult with BD and your healthcare organization regarding replacement or alternative products.

The recalled product

Product
BD TEXIUM CLOSED MALE LUER WITH FEMALE CAP, REF: 10012241-0500
Manufacturer
BD SWITZERLAND SARL
Category
Medical Device — Drug Transfer System
Hazard
  • leak
  • exposure-to-hazardous-drugs
  • underdosing

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 (20)

  • REF/UDI-DI/Lot(Expiration): 10012241-0500/10885403221705/23045145(April 3
  • 2026)
  • 23045146(April 3
  • 23055091(May 4
  • 23065090(June 3
  • 23075107(July 5
  • 23095124(September 8
  • 23105027(October 3
  • 23115047(November 2
  • 23125146(December 5
  • 24015245(January 11
  • 2027)
  • 24025887(February 7
  • 24026421(February 27
  • 24036126(March 25
  • 24045690(April 24
  • 24066893(June 25
  • 24075111(July 26
  • 24095556(September 24
  • 24125014(December 2

Distribution

Distributed nationwide across the United States.

Related recalls

Same category