CLASS II ONGOING Device recall · Reported 18 Jun 2025 · FDA Enforcement Report
Bd Texium Closed Male Luer With Female Cap recalled
BD Switzerland Sarl is recalling Bd Texium Closed Male Luer With Female Cap, 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-1973-2025
- 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 CLOSED MALE LUER WITH FEMALE CAP, REF: 10012241-0500
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): 10012241-0500/10885403221705/23045145(April 3, 2026), 23045146(April 3, 2026), 23055091(May 4, 2026), 23065090(June 3, 2026), 23075107(July 5, 2026), 23095124(September 8, 2026), 23105027(October 3, 2026), 23115047(November 2, 2026), 23125146(December 5, 2026), 24015245(January 11, 2027), 24025887(February 7, 2027), 24026421(February 27, 2027), 24036126(March 25, 2027), 24045690(April 24, 2027), 24066893(June 25, 2027), 24075111(July 26, 2027), 24095556(September 24, 2027), 24125014(December 2, 2027), 23035049(March 1, 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 96737| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| 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 | |
| CLASS II | BD Texium recalled by Bd Switzerland Sarl | 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 |
Other Other Medical Devices recalls
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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 |