Class II Recall

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:

Summary

The FDA issued a Class II for BD Texium: 3 mL, REF: MY8003-0006; 5 mL, REF: MY8005-0006; 10 mL, REF: MY8010-00 by BD SWITZERLAND SARL. Reason: Sterile, single use closed system drug transfer devices, standalone or on infusion sets or bonded syringes, may leak at the interface between the clos.

Details

Source

Device Recall

External ID

Z-1972-2025

Action Date

2025-06-18

Status

Ongoing

Product Description

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

Lot/Code Info: REF/UDI-DI/Lot(Expiration): MY8003-0006/7613203018821/24015489(January 22, 2027), 24025879(February 7, 2027), 24045651(April 24, 2027), 24055852(May 27, 2027), 24066957(June 25, 2027), 24075170(July 26, 2027), 24095519(September 24, 2027), 92215801(June 7, 2025), 92217802(June 27, 2025), 92220702(July 26, 2025), 92221502(August 3, 2025), 92303201(February 1, 2026), 92303202(February 1, 2026), 92312301(May 3, 2026), 92316401(June 13, 2026); MY8005-0006/7613203018838/24025878(February 7, 2027), 24026382(February 27, 2027), 24036112(March 25, 2027), 24045650(April 24, 2027), 24055851(May 27, 2027), 24066956(June 25, 2027), 24075169(July 26, 2027), 24095517(September 24, 2027), 92229203(October 19, 2025), 92229204(October 19, 2025), 92229701(October 24, 2025), 92230602(November 2, 2025), 92304101(February 10, 2026), 92308703(March 28, 2026), 92314401(May 24, 2026), 92314402(May 24, 2026); MY8010-0006/7613203018845/24025880(February 7, 2027), 24036111(March 25, 2027), 24045652(April 24, 2027), 24066958(June 25, 2027), 24075171(July 26, 2027), 24085488(August 26, 2027), 24095518(September 24, 2027), 24105168(October 25, 2027), 92217101(June 20, 2025), 92222903(August 17, 2025), 92233202(November 28, 2025), 92233201(November 28, 2025), 92300204(January 2, 2026), 92300901(January 9, 2026), 92301901(January 19, 2026), 92301902(January 19, 2026), 92303203(February 1, 2026), 92314403(May 24, 2026); MY8020-0006/7613203018852/24025882(February 7, 2027), 24025883(February 7, 2027), 24026385(February 27, 2027), 24036110(March 25, 2027), 24045649(April 24, 2027), 24055853(May 27, 2027), 24066954(June 25, 2027), 24075168(July 26, 2027), 24085487(August 26, 2027), 24095515(September 24, 2027), 92221501(August 3, 2025), 92221503(August 3, 2025), 92222904(August 17, 2025), 92228502(October 12, 2025), 92228701(October 14, 2025), 92228702(October 14, 2025), 92229202(October 19, 2025), 92234001(December 6, 2025), 92301701(January 17, 2026), 92301702(January 17, 2026), 92302401(January 24, 2026), 92307401(March 15, 2026), 92310902(April 19, 2026); MY8030-0006/7613203026093/24025881(February 7, 2027), 24026384(February 27, 2027), 24036109(March 25, 2027), 24045648(April 24, 2027), 24066955(June 25, 2027), 24075167(July 26, 2027), 92215802(June 7, 2025), 92219201(July 11, 2025), 92220701(July 26, 2025), 92220801(July 27, 2025), 92225802(September 15, 2025), 92226501(September 22, 2025), 92231902(November 15, 2025); MY8060-0006/7613203018869/23125068(December 2, 2026), 24026383(February 27, 2027), 24045653(April 24, 2027), 24066879(June 24, 2027), 24075001(July 1, 2027), 24085489(August 26, 2027), 24095516(September 24, 2027), 24115310(November 5, 2027), 92218602(July 5, 2025), 92222001(August 8, 2025), 92223602(August 24, 2025), 92224302(August 31, 2025), 92225803(September 15, 2025), 92227002(September 27, 2025), 92227001(September 27, 2025), 92227901(October 6, 2025), 92233601(December 2, 2025), 92310102(April 11, 2026), 92310901(April 19, 2026);

Quantity Affected: 812,165

Reason for Recall

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.

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.

Type: Voluntary: Firm initiated

Recall Initiated: 2025-05-12

Company

BD SWITZERLAND SARL

Eysins

Context & Analysis

This is a Class II recall. Class II recalls indicate that use of or exposure to the product may cause temporary or medically reversible health consequences, or that the probability of serious consequences is remote.

This was one of 180 device recalls issued in the same week, part of 403 device-related FDA actions this month.

BD SWITZERLAND SARL has 9 FDA actions in our database, including 9 recalls.

Frequently Asked Questions

What is a Class II recall?

A Class II recall means the product may cause temporary or medically reversible adverse health consequences, or the probability of serious adverse consequences is remote. Consumers should discontinue use.

What should I do if I have this product?

Stop using the product. Check the product against the specific lot numbers or identifiers listed in the recall. Contact the manufacturer (BD SWITZERLAND SARL) or your retailer for a refund or replacement. If you experienced adverse effects, report them to the FDA via MedWatch.

How often does BD SWITZERLAND SARL have FDA actions?

BD SWITZERLAND SARL has 9 FDA actions in our database, including 9 recalls and 0 device clearances.

Where can I find the official FDA record?

The official record is available on FDA.gov. Search for "Z-1972-2025" on FDA.gov for the full record. You can also use the openFDA API to query this record programmatically.

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