FDA Medical devices recall ·
BD TEXIUM CLOSED MALE LUER WITH FEMALE CAP recall
- Recall number
- Z-1974-2025
- Date
- (initiated May 12, 2025)
- Company / brand
- Bd Switzerland Sarl
Terre Bonne Park A4, Eysins, Switzerland - Category
- Medical devices › Class II
- Classification
- Class II
- Status
- Ongoing
- Units affected
- 1,006,512
- Hazard tags
- Sterility
- Initiated by
- Voluntary: Firm initiated
Read the official FDA notice ↗
Product
BD TEXIUM CLOSED MALE LUER WITH FEMALE CAP, REF: 10012241; BD TEXIUM (China), REF: 10012241 CHINA
Why was it recalled?
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.
What should you do?
FDA enforcement reports do not list a consumer remedy. Check the product codes below against what you have; if it matches, stop using it and follow the instructions in the firm's or FDA's official notice, or contact the company. If you have health concerns, contact your healthcare provider.
Product codes & lot numbers
REF/UDI-DI/Lot(Expiration): 10012241/07613203010450/23015679(January 31, 2026), 23035092(March 6, 2026), 23055076(May 4, 2026), 23075108(July 5, 2026), 23095125(September 8, 2026), 23105028(October 3, 2026), 23125147(December 5, 2026), 24015246(January 11, 2027), 24026422(February 27, 2027), 24036125(March 25, 2027), 24045689(April 24, 2027), 24066894(June 25, 2027), 24075112(July 26, 2027), 24095557(September 24, 2027), 24115004(November 1, 2027); 10012241 CHINA/10885403238383/23095707(September 14, 2026), 24025890(February 7, 2027), 24105002(October 3, 2027)
Distribution
Worldwide - US Nationwide distribution including in the states of MA, CA, IL, AK, AL, MO, FL, VA, ME, NC, MD, IA, WI, AZ, CO, KY, IN, TX, AR, NJ, NY, MT, NE, TN, PA, GA, WA, KS, MN, ID, SC, MI, SD, OH, WV, LA, ND, VT, GU, NV, UT, OK, OR, DE, NM, MS, WY and the countries of CA, AU, NZ, CN.
States: Alaska Alabama Arkansas Arizona California Colorado Delaware Florida Georgia Iowa Idaho Illinois Indiana Kansas Kentucky Louisiana Massachusetts Maryland Maine Michigan Minnesota Missouri Mississippi Montana North Carolina North Dakota Nebraska New Jersey New Mexico Nevada New York Ohio Oklahoma Oregon Pennsylvania South Carolina South Dakota Tennessee Texas Utah Virginia Vermont Washington Wisconsin West Virginia Wyoming
What does Class II mean?
Class II means use of or exposure to the product may cause temporary or medically reversible adverse health consequences, or the probability of serious harm is remote.
Source: FDA (medical devices), recall Z-1974-2025. Official notice. Republished from public data; RecallFlag is not affiliated with the FDA.