FDAFDA · Food and drugs·Recall number Z-1971-2025
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
Published June 18, 2025 · Recall initiated: May 12, 2025
Status when published: Ongoing — openFDA updates weekly, so this field may not reflect the current status. Always confirm with the official notice.
What's the hazard
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 to do
Voluntary: Firm initiated · Letter
Recall details
- Manufacturer
- BD SWITZERLAND SARL
- Distributor
- 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.
- Lot
- UDI-DI/Lot(Expiration): MY8003/10885403221651/23125144(December 5, 2026), 24015468(January 20, 2027), 24025611(February 5, 2027), 24026390(February 27, 2027), 24036107(March 25, 2027), 24045647(April 24, 2027), 24055859(May 27, 2027), 24095513(September 24, 2027), 92217803(June 27, 2025), 92225801(September 15, 2025), 92231303(November 9, 2025), 92300201(January 2, 2026), 92308702(March 28, 2026), 92309501(April 5, 2026), 92313601(May 16, 2026), 92315701(June 6, 2026) MY8005/10885403221668/23125145(December 5, 2026), 24015467(January 20, 2027), 24026387(February 27, 2027), 24045646(April 24, 2027), 24055858(May 27, 2027), 24075164(July 26, 2027), 24095512(September 24, 2027), 92215201(June 1, 2025), 92220802(July 27, 2025), 92225502(September 12, 2025), 92315102(May 31, 2026); MY8010/10885403221675/24015312(January 15, 2027), 24025610(February 5, 2027), 24045645(April 24, 2027), 24055857(May 27, 2027), 24066953(June 25, 2027), 24075165(July 26, 2027), 24085486(August 26, 2027), 24095511(September 24, 2027), 24105167(October 25, 2027), 92218601(July 5, 2025), 92222902(August 17, 2025), 92223601(August 24, 2025), 92229201(October 19, 2025), 92230701(November 3, 2025), 92231301(November 9, 2025), 92231302(November 9, 2025), 92307402(March 15, 2026), 92311601(April 26, 2026), 92315101(May 31, 2026); MY8020/10885403221682/23115069(November 3, 2026), 24015311(January 15, 2027), 24025935(February 7, 2027), 24035566(March 5, 2027), 24036106(March 25, 2027), 24045644(April 24, 2027), 24055856(May 27, 2027), 24066952(June 25, 2027), 24075163(July 26, 2027), 24085485(August 26, 2027), 24095083(September 9, 2027), 24105196(October 30, 2027), 92216401(June 13, 2025), 92217801(June 27, 2025), 92218001(June 29, 2025), 92219202(July 11, 2025), 92231901(November 15, 2025), 92300205(January 2, 2026), 92300902(January 9, 2026), 92309503(April 5, 2026), 92310101(April 11, 2026), 92313002(May 10, 2026), 92313602(May 16, 2026) MY8030/10885403230523/23115070(November 3, 2026), 23125143(December 5, 2026), 24015264(January 12, 2027), 24015644(January 27, 2027), 24026389(February 27, 2027), 24036105(March 25, 2027), 24045643(April 24, 2027), 24055855(May 27, 2027), 24075162(July 26, 2027), 24085484(August 26, 2027), 24095509(September 24, 2027), 24115110(November 5, 2027), 92225501(September 12, 2025), 92233602(December 2, 2025), 92307403(March 15, 2026), 92308701(March 28, 2026), 92309502(April 5, 2026), 92315702(June 6, 2026), 92316402(June 13, 2026), 24066951(June 25, 2027); MY8060/10885403221699/23115496(November 28, 2026), 23125393(December 18, 2026), 24015102(January 8, 2027), 24026388(February 27, 2027), 24036104(March 25, 2027), 24045366(April 23, 2027), 24055854(May 27, 2027), 24075166(July 26, 2027), 24095596(September 24, 2027), 24115111(November 14, 2027), 92216402(June 13, 2025), 92222002(August 8, 2025), 92222901(August 17, 2025), 92224303(August 31, 2025), 92224301(August 31, 2025), 92226502(September 22, 2025), 92228501(October 12, 2025), 92230702(November 3, 2025), 92230703(November 3, 2025), 92230704(November 3, 2025), 92300202(January 2, 2026), 92300203(January 2, 2026), 92306703(March 8, 2026), 92306701(March 8, 2026), 92306702(March 8, 2026), 92311602(April 26, 2026), 92312302(May 3, 2026), 92313001(May 10, 2026), 92316601(June 15, 2026), 92316602(June 15, 2026)
- Risk classification
- Class II
- Area (FDA)
- device
- Country
- Switzerland
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