Agency classClass IIOur severity:High FDA (Devices)·Z-1436-2022·Announced 2022-07-27

BD Connecta 3-Way Stopcocks Recalled Due to Potential Leakage

Becton Dickinson recalls BD Connecta 3-Way Stopcocks due to potential leakage at the housing that may delay 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: FDA Class II recall of a medical device with potential for serious patient harm including treatment interruption, biohazard exposure, and under-dosing. No injuries have been reported. Per the rubric, this qualifies as High (Score 3) for a risk-of-harm product where injury has not yet been reported.

Plain-English summary

Becton Dickinson & Company is recalling BD Connecta 3-Way Stopcocks (Catalog No. 394900, OUS) due to a potential manufacturing defect that may allow leakage at the housing component of the stopcock.

The affected units (54010 total) were distributed worldwide, including to hospitals and healthcare facilities across the United States and internationally to Belgium, China, India, Indonesia, Japan, Korea, Nepal, Philippines, Singapore, Sri Lanka, Thailand, and Vietnam. The affected lot number is 1214380 with an expiration date of July 31, 2024.

A leak in the stopcock may result in treatment delay or interruption, exposure of patients to infusate and biohazardous material, under-dosing or under-infusion, contamination, and air ingress into the infusion line. No injuries or illnesses have been reported.

Healthcare facilities and individuals using units from the affected lot should contact their medical device supplier or Becton Dickinson directly for return or replacement instructions.

The recalled product

Product: BD Connecta 3-Way Stopcocks Catalog No. 394900 (OUS)
Manufacturer: Becton Dickinson & Company
Category: Medical Device — Infusion therapy equipment
Hazard: leakage
treatment-delay
biohazard-exposure
under-infusion
contamination
air-ingress
Affected units: 54,010

Is your product affected?

Check your packaging against the codes below. If any of them match, the product is part of this recall.

Lot numbers (1)

GTIN: 382903949007 Lot Numbers/Exp.Date: 1214380 7/31/2024

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

See all →

Severe
BD Quincke spinal trays recalled over Huons bupivacaine quality issues
FDA (Devices) · 2026-06-10
Severe
BD Whitacre 24 gauge spinal trays recalled over bupivacaine quality issues
FDA (Devices) · 2026-06-10
Severe
BD Whitacre 22G spinal trays recalled in Huons bupivacaine sub-recall
FDA (Devices) · 2026-06-10
Severe
BD Whitacre spinal trays across nine catalog numbers recalled over bupivacaine
FDA (Devices) · 2026-06-10
Severe
BD spinal trays recalled as a sub-recall of Huons bupivacaine
FDA (Devices) · 2026-06-10

Same hazard · leakage