CLASS II ONGOING Device recall · Reported 18 Jun 2025 · FDA Enforcement Report
BD Texium recalled by Bd Switzerland Sarl
BD Switzerland Sarl is recalling BD Texium, distributed nationwide in the US. The recall was initiated on 12 May 2025 and the FDA has classified it as Class II.
Check your package
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
Recall details
- Recall number
- Z-1972-2025
- FDA event ID
- 96737
- Recalling firm
- BD Switzerland Sarl, Eysins
- Classification
- Class II
- Status
- Ongoing
- Recall initiated
- 12 May 2025
- FDA classified
- 12 Jun 2025
- Reported
- 18 Jun 2025
- Type
- Voluntary: Firm initiated
- Customers notified by
- Letter
- Reason category
- Sterility
- Device type
- Other Medical Devices
Timeline
| 12 May 2025 | Recall initiated by company | |
| 12 Jun 2025 | Classified by FDA | +31 days |
| 18 Jun 2025 | Published in enforcement report | +6 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
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.
A sterility recall means a product that must be sterile, such as an injection or eye drop, may be contaminated. Using a non-sterile product can cause serious infection.
Product as listed by the FDA
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
Where it was distributed
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.
Nationwide AlaskaAlabamaArkansasArizonaCaliforniaColoradoDelawareFloridaGeorgiaIowaIdahoIllinoisIndianaKansasKentuckyLouisianaMassachusettsMarylandMaineMichigan
Questions about this recall
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.
Which lots are affected?
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);
Where was it sold?
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.
What should I do if I have it?
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
What does Class II mean?
Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.
Read the official FDA notice · Source record retrieved 26 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.
Other products in this recall event
4 other products · FDA event 96737This product is part of a recall event; the main page for the event is Bd Texium Closed Male Luer With Female Cap recalled.
| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| CLASS II | Bd Texium Closed Male Luer With Female Cap recalled | BD Switzerland Sarl | Sterility | Nationwide | |
| CLASS II | BD Texium Needle-Free Syringe recalled by Bd Switzerland Sarl | BD Switzerland Sarl | Sterility | Nationwide | |
| CLASS II | Bd Texium Closed Male Luer With Female Cap recalled | BD Switzerland Sarl | Sterility | Nationwide | |
| CLASS II | Alaris Pump Infusion Set: SmartSite Bag Access Non-Vented recalled | BD Switzerland Sarl | Sterility | Nationwide |
More recalls from BD Switzerland Sarl
All 15| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Device | CLASS I | BD Alaris Pump Infusion Sets 10561554* recalled by BD Switzerland Sarl | BD Switzerland Sarl | Other | Nationwide |
| Device | CLASS II | Non-DEHP Minibore Extension Set RES ME2010 recalled | BD Switzerland Sarl | Sterility | 26 states |
| Device | CLASS II | Medline 111 Gravity Set W/3 Needle Free Y-Sites recalled | BD Switzerland Sarl | Other | IL |
| Device | CLASS II | BD Connecta" BD Luer-Lok" recalled by Bd Switzerland Sarl | BD Switzerland Sarl | Foreign Material | 39 states |
| Device | CLASS II | BD PhaSeal Injector Luer (N30C) recalled by Bd Switzerland Sarl | BD Switzerland Sarl | Packaging Defects | Nationwide |
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|---|---|---|---|---|---|
| Device | CLASS II | NOxBOXi Nitric Oxide Delivery System recalled | Noxbox | Device Malfunction | Nationwide |
| Device | CLASS II | Palacos R pro recalled by Heraeus Medical GmbH (Dental | Heraeus Medical GmbH (Dental Division) | Packaging Defects | Nationwide |
| Device | CLASS II | Intrapulmonary Percussive Ventilation, IPV 1, Product Number: S00065 recalled | Percussionaire | Other | Nationwide |
| Device | CLASS II | Positron Emission Tomography and Computed Tomography System recalled | Shanghai United Imaging Healthcare | Device Malfunction | Nationwide |
| Device | CLASS II | Intrapulmonary Percussive Ventilation, IPV-1C recalled by Percussionaire | Percussionaire | Other | Nationwide |