The Recall Desk

FDA (Devices) recall action 96737

BD SWITZERLAND SARL recalled 5 products on 2025-06-18

The FDA (Devices) publishes a recall like this one as 5 separate product records. They share a firm, a date and a cause; this page is all of them in one place, so the scale of the action is visible rather than spread across 5 pages.

Products
5
Announced
2025-06-18
Critical
0
Units
6,764,157

Why these products were 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.

The agency’s own wording, quoted from the enforcement report.

The unit total adds up the quantities the agency stated for each product. Where a product record gave no figure, or gave a weight rather than a count, it contributes nothing — so the real total is at least this, never less.

States named across these recalls

1–5 of 5

  • HighFDA (Devices)··2025-06-18

    Alaris Pump Infusion Sets may leak at male luer connections

    BD Switzerland is recalling multiple Alaris Pump Infusion Set models worldwide due to potential leaks at the connection between the closed male luer component and needle-free connector, which could delay procedures, interrupt treatment, expose patients to hazardous drugs, or result in underdosing.

    Product
    Alaris Pump Infusion Set: SmartSite Bag Access Non-Vented Bonded Texium With Priming Cap Back Check Valve 2 SmartSite Y-Sites, REF: 10013361T; SmartSite Bag Access Non-Vented Bonded Texium Closed Male Luer With Priming Cap, REF: 10321213T; SmartSite Bag Access Non-Vented Low
    Category
    Distribution
    47 states
  • HighFDA (Devices)··2025-06-18

    BD TEXIUM Closed Male Luer Drug Transfer Device Recall

    BD TEXIUM Closed Male Luer devices may leak at the interface between the closed male luer component and needle-free connector. The leak could cause procedure delays, treatment interruptions, exposure to hazardous drugs, and underdosing of medication.

    Product
    BD TEXIUM CLOSED MALE LUER WITH FEMALE CAP, REF: 10012241-0500
    Category
    Distribution
    47 states
  • SevereFDA (Devices)··2025-06-18

    BD Texium Closed System Drug Transfer Devices May Leak at Connector

    BD Texium closed system drug transfer devices in multiple sizes may leak at the interface between the male luer component and needle-free connector, potentially causing treatment delays, exposure to hazardous drugs, and underdosing.

    Product
    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
    Category
    Distribution
    47 states
  • HighFDA (Devices)··2025-06-18

    BD TEXIUM Closed Male Luer Devices Recalled for Leaking Interface Risk

    BD TEXIUM closed male luer drug transfer devices may leak at the interface between the closed male luer component and the needle-free connector, potentially causing procedure delays, treatment interruptions, hazardous drug exposure, and medication underdosing.

    Product
    BD TEXIUM CLOSED MALE LUER WITH FEMALE CAP, REF: 10012241; BD TEXIUM (China), REF: 10012241 CHINA
    Category
    Distribution
    47 states
  • HighFDA (Devices)··2025-06-18

    BD Texium Needle-Free Syringe Recalled for Potential Leakage at Luer Interface

    BD Texium Needle-Free Syringes (multiple sizes) may leak at the interface between the male luer component and needle-free connector, potentially causing treatment delays, medication underdosing, or exposure to hazardous drugs.

    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
    Category
    Distribution
    47 states