The Recall Desk
Agency classClass IIOur severity:HighFDA (Devices)·Z-1971-2025·Announced 2025-06-18

BD Texium Needle-Free Syringe Recalled for Potential Leakage at Luer Interface

BD Texium Needle-Free Syringes (multiple sizes) may leak at the interface between the male luer component and needle-free connector, potentially causing treatment delays, medication underdosing, or exposure to hazardous drugs.

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. The hazard involves potential exposure to hazardous drugs and medication underdosing—serious risks in drug delivery—although the source text does not report any illnesses or injuries. The risk of harm is direct and significant, justifying a High severity rating.

Plain-English summary

BD SWITZERLAND SARL is recalling BD Texium Needle-Free Syringes in 3 mL, 5 mL, 10 mL, 20 mL, 30 mL, and 60 mL sizes. The syringes are sterile, single-use closed system drug transfer devices that may be used standalone, on infusion sets, or bonded to syringes.

The recalled products may leak at the interface between the closed male luer component and the needle-free connector. This potential leakage could cause procedure delays, treatment interruptions, exposure to hazardous drugs, and/or underdosing of medication.

The affected syringes have been distributed nationwide across the United States and to Canada, Australia, New Zealand, and China. A total of 1,265,400 units are involved in this recall.

Patients and healthcare providers who have or use these devices should contact their healthcare facility or BD for further guidance on the recall and to determine appropriate next steps.

The recalled product

Product
BD Texium Needle-Free Syringe: 3 mL, REF: MY8003; 5 mL, REF: MY8005; 10 mL, REF: MY8010; 20 mL, REF: MY8020; 30 mL, REF: MY8030; 60 mL, REF: MY8060
Manufacturer
BD SWITZERLAND SARL
Category
Medical Device — Injection / Infusion Device
Hazard
Affected units
1,265,400

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)

  • UDI-DI/Lot(Expiration): MY8003/10885403221651/23125144(December 5
  • 2026)
  • 24015468(January 20
  • 2027)
  • 24025611(February 5
  • 24026390(February 27
  • 24036107(March 25
  • 24045647(April 24
  • 24055859(May 27
  • 24095513(September 24
  • 92217803(June 27
  • 2025)
  • 92225801(September 15
  • 92231303(November 9
  • 92300201(January 2
  • 92308702(March 28
  • 92309501(April 5
  • 92313601(May 16
  • 92315701(June 6
  • 2026) MY8005/10885403221668/23125145(December 5

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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