The Recall Desk
Agency classClass IIOur severity:SevereFDA (Devices)·Z-1972-2025·Announced 2025-06-18

BD Texium Closed System Drug Transfer Devices May Leak at Connector

BD Texium closed system drug transfer devices in multiple sizes may leak at the interface between the male luer component and needle-free connector, potentially causing treatment delays, exposure to hazardous drugs, and 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 4/5 (Severe).

The hazard poses a serious risk of illness, injury, or structural failure. Stop using the product immediately and contact the manufacturer for a refund or repair.

Our severity reasoning: FDA Class II medical device recall involving drug transfer devices with a potential to cause treatment interruptions, medication underdosing, and exposure to hazardous drugs. Although no hospitalizations or injuries are explicitly reported in the source text, the hazard involves critical-use medical devices where functional failure poses significant risk of harm, meeting the Severe criterion.

Plain-English summary

BD SWITZERLAND SARL is recalling BD Texium sterile, single-use closed system drug transfer devices in six sizes (3 mL, 5 mL, 10 mL, 20 mL, 30 mL, and 60 mL). These devices are sold standalone or bonded to infusion sets or syringes. Approximately 812,165 units have been distributed worldwide, including throughout the United States and in Canada, Australia, New Zealand, and China.

The devices may leak at the interface between the closed male luer component and the needle-free connector. This defect may cause procedure delays, treatment interruptions, exposure to hazardous drugs, and/or underdosing of medication. The recall affects multiple lot numbers with expiration dates ranging from 2025 to 2027.

Patients and healthcare providers who have received or are using these devices should discontinue use and consult their healthcare provider regarding replacement devices. Healthcare facilities should identify affected lots using the provided reference numbers and lot information, and take appropriate action to remove the recalled devices from use.

The recalled product

Product
BD Texium: 3 mL, REF: MY8003-0006; 5 mL, REF: MY8005-0006; 10 mL, REF: MY8010-0006; 20 mL, REF: MY8020-0006; 30 mL, REF: MY8030-0006; 60 mL, REF: MY8060-0006
Manufacturer
BD SWITZERLAND SARL
Category
Medical Device — Drug Transfer Device / Infusion Set Component
Hazard
Affected units
812,165

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): MY8003-0006/7613203018821/24015489(January 22
  • 2027)
  • 24025879(February 7
  • 24045651(April 24
  • 24055852(May 27
  • 24066957(June 25
  • 24075170(July 26
  • 24095519(September 24
  • 92215801(June 7
  • 2025)
  • 92217802(June 27
  • 92220702(July 26
  • 92221502(August 3
  • 92303201(February 1
  • 2026)
  • 92303202(February 1
  • 92312301(May 3
  • 92316401(June 13
  • MY8005-0006/7613203018838/24025878(February 7
  • 24026382(February 27

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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