Agency classClass IIOur severity:High FDA (Devices)·Z-2514-2026·Announced 2026-06-24

BD Connecta stopcock Port C may over thread rather than tightening

BD Connecta BD Luer-Lok 360 stopcocks, REF 394910, are being recalled because the Port C connection may over thread or spin rather than tightening securely. 2,465,500 units affected.

The agency’s classification

FDA (Devices): Class II

Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.

This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work

What this means for you

Our assessment, not the agency’s: severity 3/5 (High).

Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.

Our severity reasoning: FDA Class II recall where an infusion connection may not tighten securely in use, a risk of harm with no injuries reported in the source.

Plain-English summary

The BD Connecta BD Luer-Lok 360 stopcock, REF 394910, UDI-DI 00382903949106, is being recalled. BD Connecta stopcocks are used to administer fluids or medication through one or two different ports via an IV cannula or extension tube. The action covers 2,465,500 units.

The stated reason is that, due to stopcock issues when using the plastic luer-lok syringe, the connection at Port C may over thread or continue to spin rather than tightening securely. According to the manufacturer, this behaviour has led some clinical users to perceive the connection as unstable. The FDA classified the action as Class II.

Distribution was across 39 US states and the District of Columbia, and to Japan. The stopcocks are supplied to healthcare facilities rather than sold to consumers.

Facilities should identify affected stock using the catalog number, UDI-DI and lot numbers in the recall notice and follow the instructions issued by BD.

The recalled product

Product: 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…
Manufacturer: BD SWITZERLAND SARL
Category: Medical Device — IV stopcock
Hazard: connection-failure
over-threading
infusion-delivery
class-ii
Affected units: 2,465,500

Distribution

Distributed in 39 states:

Same manufacturer · BD SWITZERLAND SARL

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