BD Texium: 3 mL — Class II medical device recall Z-1972-2025
Ongoing recall by BD SWITZERLAND SARL, reported 2025-06-18, distributed nationwide. Sterile, single use closed system drug transfer devices, standalone or on infusion sets or bonded syringes, ma
| Recall number | Z-1972-2025 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Ongoing |
| Voluntary or mandated | Voluntary |
| Recalling firm | BD SWITZERLAND SARL, Eysins, Switzerland |
| Recall initiated | 2025-05-12 |
| Classified | 2025-06-12 |
| Reported by FDA | 2025-06-18 |
| Distributed | Nationwide (US) |
| Quantity | 812,165 |
| Reason classes | sterility, packaging |
| UPC / GTIN / UDI-DI | 07613203018821, 07613203018838, 07613203018845, 07613203018852, 07613203018869, 07613203026093 |
| Model numbers | MY8003-0006, MY8005-0006, MY8010-0006, MY8020-0006, MY8030-0006, MY8060-0006 |
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
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.
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/Z-1972-2025. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.