Agency classClass IIOur severity:High FDA (Devices)·Z-1434-2022·Announced 2022-07-27

BD Connecta Stopcock recalled for potential housing leakage risk

Becton Dickinson is recalling BD Connecta Stopcocks due to potential leakage at the housing component. The defect may interrupt treatment and expose patients to biohazardous material.

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: This is an FDA Class II recall with no reported illnesses or injuries. However, the product defect poses a risk of serious harm—including treatment interruption and exposure to biohazardous material—even though such injuries have not yet been reported. Per the rubric, this qualifies as a risk-of-harm product where injury has not yet been reported.

Plain-English summary

Becton Dickinson & Company is recalling the BD Connecta Stopcock Without Extension Tube (Catalog No. 394602) due to a potential defect in the housing component that may cause leakage.

The affected product was distributed worldwide and in the United States across multiple states. Approximately 2,100,210 units are affected by this recall. Specific lot numbers and expiration dates are available from the FDA.

The potential leakage may result in treatment delay or interruption, exposure to infusate and biohazardous material, under-dosing or under-infusion, contamination, and air ingress. Healthcare facilities and providers using this product should review the affected lot numbers and expiration dates. If your facility has received affected units, contact Becton Dickinson & Company for instructions on replacement or return.

The recalled product

Product: BD Connecta Stopcock Without Extension Tube Catalog No. 394602 (OUS)
Manufacturer: Becton Dickinson & Company
Category: Medical Device — IV Access / Infusion
Hazard: leakage
under-infusion
biohazard-exposure
air-ingress
contamination
Affected units: 2,100,210

Distribution

Distributed nationwide across the United States.

The notice also names 31 states specifically:

Part of a larger recall action

This product is one of 11 recalled by Becton Dickinson & Company under a single FDA (Devices) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.

See all 11 products in this recall →

Same manufacturer · Becton Dickinson & Company

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Same hazard · leakage