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.
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 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
- 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
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.
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