FDAClass II · Medical device · Recalled June 24, 2026

BD Connecta" BD Luer-Lok" 360 REF 394910 UDI-DI code recall — BD SWITZERLAND SARL

Hazard: Due to stopcock issues when using the plastic luer-lok syringe, the connection at the Port C may over thread or continue to spin rather than tightening securely. This behavior has led some clinical users to perceive the connection as unstable.

Class II: may cause temporary or medically reversible health consequences.

View the official FDA enforcement record (openFDA) ↗

Official recall ID: Z-2514-2026
Brand: BD SWITZERLAND SARL
Classification: Class II
Units affected: 2,465,500 units
Recall status: Ongoing
Initiated: Voluntary: Firm initiated

Description

BD Connecta" BD Luer-Lok" 360 REF 394910 UDI-DI code: 00382903949106 BD Connecta" Stopcocks are used to administer fluids or medication through one or two different ports via an IV cannula or extension tube. The ports can be used to sample blood or for hemodynamic monitoring. When used with IV lipid nutritional products, the stopcock device can be used for up to 24 hours.

Affected products

BD Connecta" BD Luer-Lok" 360 REF 394910 UDI-DI code

Companies & origin

Recalling firm location: Eysins, Switzerland
Firm address: Terre Bonne Park A4, Route De Crassier 17, N/A

Identifying details (verbatim from the notice)

Product codes / lots: Catalog/Model Number: 394910 UDI-DI code: 00382903949106 Lot Numbers: 4277968 4277973 4282451 4282461 4289801 4290582 4292904 4295848 4299949 4303841 4305108 4306700 5129635 5129642 5129649 5129650 5129651 5139250 5139251 5139252 5150181 5153940 5164061 5164062 5178078 5181442 5183810 5183816 5183824 5183828 5218287 5218291 5218293 5218299 5218302 5241476 5247729 5247731 5251098 5275601 5275602
Distribution: U.S.: AK, AL, AR, AZ, CA, CO, DC, FL, GA, IA, IL, IN, KS, KY, LA, MA, MD, MI, MN, MO, MS, NC, NE, NJ, NM, NY, OH, OK, OR, PA, SC, SD, TN, TX, UT, VA, WA, WI, and WV. O.U.S.: Japan
Firm notified the public via: Letter
FDA event ID: 98855
Recall initiated: May 21, 2026
FDA classified: June 18, 2026
FDA report date: June 24, 2026

Source: U.S. Food & Drug Administration. This page mirrors the official public-domain record verbatim; the linked government source is authoritative. Source last checked July 24, 2026 at 12:00 AM UTC.

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