The Recall Desk
Agency classClass IIOur severity:HighFDA (Devices)·Z-1974-2025·Announced 2025-06-18

BD TEXIUM Closed Male Luer Devices Recalled for Leaking Interface Risk

BD TEXIUM closed male luer drug transfer devices may leak at the interface between the closed male luer component and the needle-free connector, potentially causing procedure delays, treatment interruptions, hazardous drug exposure, and medication underdosing.

The agency’s classification

FDA (Devices): Class II

Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.

This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work

What this means for you

Our assessment, not the agency’s: severity 3/5 (High).

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 with risk of harm (exposure to hazardous drugs, medication underdosing, procedure interruption). The source text does not report any illnesses or injuries, but the hazard—leaking at a critical interface in drug delivery—poses potential serious harm. Per the rubric, risk-of-harm products where injury has not yet been reported score as High (3).

Plain-English summary

BD Switzerland SARL is recalling BD TEXIUM Closed Male Luer with Female Cap (REF: 10012241) devices distributed worldwide, including throughout the United States. These sterile, single-use closed system drug transfer devices are used either standalone or on infusion sets or bonded syringes.

The devices may leak at the interface between the closed male luer component and the needle-free connector. This leak could result in procedure delay, treatment interruption, exposure to hazardous drugs, and/or underdosing of medication.

Affected lots and expiration dates are specified in the FDA recall notice. Consumers and healthcare providers who have these devices should discontinue use and contact BD Switzerland SARL or the FDA for further instructions. Healthcare facilities should review their inventory and verify that affected lots are no longer in use.

The recalled product

Product
BD TEXIUM CLOSED MALE LUER WITH FEMALE CAP, REF: 10012241; BD TEXIUM (China), REF: 10012241 CHINA
Manufacturer
BD SWITZERLAND SARL
Category
Medical Device — Drug Transfer Device
Hazard
Affected units
1,006,512

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): 10012241/07613203010450/23015679(January 31
  • 2026)
  • 23035092(March 6
  • 23055076(May 4
  • 23075108(July 5
  • 23095125(September 8
  • 23105028(October 3
  • 23125147(December 5
  • 24015246(January 11
  • 2027)
  • 24026422(February 27
  • 24036125(March 25
  • 24045689(April 24
  • 24066894(June 25
  • 24075112(July 26
  • 24095557(September 24
  • 24115004(November 1
  • 10012241 CHINA/10885403238383/23095707(September 14
  • 24025890(February 7
  • 24105002(October 3

Distribution

Distributed nationwide across the United States.

The notice also names 47 states specifically:

Part of a larger recall action

This product is one of 5 recalled by BD SWITZERLAND SARL under a single FDA (Devices) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.

See all 5 products in this recall →

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