BD Texium Drug Transfer Devices May Leak at Connector Interface
BD Texium closed-system drug transfer devices may leak at the connector interface, potentially causing treatment delays, drug exposure, and medication underdosing. Over 812,000 units are affected worldwide.
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 involving a theoretical risk of leakage and hazardous drug exposure. No injuries or illnesses have been reported, so per the rubric, the maximum score for a risk-of-harm product without reported harm is 3 (High).
Plain-English summary
BD Texium is a sterile, single-use closed-system drug transfer device manufactured by BD Switzerland SARL. The devices are available in six sizes: 3 mL, 5 mL, 10 mL, 20 mL, 30 mL, and 60 mL. Approximately 812,165 units have been distributed worldwide and throughout the United States.
The devices may leak at the interface between the closed male luer component and the needle-free connector. A leak at this connection point could result in procedure delays, treatment interruptions, exposure to hazardous drugs, and insufficient medication dosing.
This recall was initiated due to the potential for leakage. No illnesses or injuries have been reported in association with this issue.
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
- Hazard
- leakage
- hazardous-drug-exposure
- underdosing
- treatment-interruption
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.
Related recalls
Same category
- SevereMedline Spinal Block Kits Recalled for Data Integrity and Efficacy Issues
FDA (Devices) · 2026-06-03
- SevereAbiomed Automated Impella Controller recalled for motor control and pump failure risks
FDA (Devices) · 2026-06-03
- HighGE APEXPRO and CARESCAPE Telemetry Systems Risk Loss of Patient Monitoring
FDA (Devices) · 2026-06-03
- CriticalMedline spinal anesthetic kits recalled for quality and efficacy concerns
FDA (Devices) · 2026-06-03
- SevereMedline spinal anesthesia kits recalled for bupivacaine quality issues
FDA (Devices) · 2026-06-03