BD Connecta BD Luer-Lok 360 — Class II medical device recall Z-1509-2025
Ongoing recall by BD SWITZERLAND SARL, reported 2025-04-09, distributed in AK, AL, AR, AZ, CA, CO, FL, GA…. Due to specific lots of luer-lok devices were shipped to the U.S. market with an Outside US Instruction for Us
| Recall number | Z-1509-2025 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Ongoing |
| Voluntary or mandated | Voluntary |
| Recalling firm | BD SWITZERLAND SARL, Eysins, Switzerland |
| Recall initiated | 2025-02-20 |
| Classified | 2025-04-02 |
| Reported by FDA | 2025-04-09 |
| Distributed | AK, AL, AR, AZ, CA, CO, FL, GA, IL, IN, KS, KY, LA, MA, MD, MI, MN, MO, MS, NC, NE, NJ, NM, NV, OH, OK, OR, PA, SC, TN, TX, UT, VA, WA, WV |
| Quantity | 500 units |
| UPC / GTIN / UDI-DI | 00382903949106 |
| Lot numbers | 4277968, 4277973, 4282451, 4282461, 4289801, 4290582, 4292904, 4295848, 4305108, 4306700 |
| Model numbers | 394910 |
Product
BD Connecta BD Luer-Lok 360, REF 394910 UDI-DI code: 00382903949106 Connecta¿ Plus 1 and Connecta¿ Plus 3 2-way and 3-way Stopcocks are control valves for use in IV. therapy and hemodynamic pressure monitoring.
Reason for recall
Due to specific lots of luer-lok devices were shipped to the U.S. market with an Outside US Instruction for Use (IFU)
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-1509-2025. 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.