[pending] BD Texium Needle-Free Syringe: 3 mL, REF: MY8003; 5 mL, REF: MY8005; 10 mL, REF: MY8010; 20 mL, REF:
Pending LLM rewrite. Source: FDA_DEVICE Z-1971-2025.
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: Pending LLM scoring against the rubric.
Plain-English summary
Sterile, single use closed system drug transfer devices, standalone or on infusion sets or bonded syringes, may leak at the interface between the closed male luer component and the needle-free connector, which may cause procedure delay, treatment interruptions, exposure to hazardous drugs, and/or underdosing of medication.
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 — Devices
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.
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