BD SWITZERLAND SARL: 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

Recall number

Z-1971-2025

Recalling firm

BD SWITZERLAND SARL

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

Status

Open, Classified

Initiated

2025-05-12

Posted

2025-06-12

Terminated

not on file

Reason

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.

Root cause

Process control

Action

On 5/12/2025, removal notices were mailed or emailed to Medical Director, Risk Manager, Medical Device Safety Officer, Nurse Managers, and Distributors who were asked to do the following: 1. Immediately review your inventory for affected product. Destroy all unused affected products subject to the recall following your institution s process for destruction. 2. Share this recall notification with all users within your facility network of the product to ensure they are also aware of this recall. 3. Complete the Customer Response Form via email to bdrc53@bd.com 4. In addition, distributors were asked to identify all customers that purchased any affected product and to provide a copy of the customer letter to all customers and to advise them of the removal notification. Report any complaints experienced with the use of this product to the firm's North American Regional Complaint Center: Phone: 1-844-823-5433 Mon-Fri 8:00am and 5:00pm CT, Email: productcomplaints@bd.com

Quantity

1,265,400

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.

Lot, serial or model codes

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)

510(k) numbers

["K071108"]

PMA numbers

not on file

Product code

FMF

Firm FEI

3012798826

Firm city

Eysins

Firm state

not on file

Firm country

Switzerland

Cite as

FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28

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