BD Connecta Stopcock Recalled for Potential Housing Leakage
Becton Dickinson is recalling approximately 1.96 million BD Connecta Stopcock devices due to potential leakage at the housing component, which could 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: FDA Class II medical device recall with potential for serious adverse outcomes including treatment delay, biohazard exposure, and contamination. No reported illnesses or injuries; the hazard remains theoretical, meeting the criteria for High severity.
Plain-English summary
Becton Dickinson & Company is recalling approximately 1,960,360 units of the BD Connecta Stopcock Without Extension Tube (Catalog No. 394601) due to potential leakage at the housing component.
The stopcock may develop leakage at the housing, which could result in delay or interruption of infusion treatment, exposure to infusate and biohazardous material, under-dosing or under-infusion, contamination, and air ingress. These potential hazards could affect patient safety during critical medical treatment.
The recalled devices were distributed worldwide, including nationwide distribution across the United States and in Belgium, China, India, Indonesia, Japan, Korea, Nepal, Philippines, Singapore, Sri Lanka, Thailand, and Vietnam. The FDA has identified specific lot numbers and expiration dates for the recalled units.
The recalled product
- Product
- BD Connecta Stopcock Without Extension Tube Catalog No. 394601 (OUS)
- Manufacturer
- Becton Dickinson & Company
- Category
- Medical Device — Infusion Device
- Affected units
- 1,960,360
Distribution
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 →Related recalls
Same manufacturer · Becton Dickinson & Company
See all →- SevereBD Quincke spinal trays recalled over Huons bupivacaine quality issues
FDA (Devices) · 2026-06-10
- SevereBD Whitacre 24 gauge spinal trays recalled over bupivacaine quality issues
FDA (Devices) · 2026-06-10
- SevereBD Whitacre 22G spinal trays recalled in Huons bupivacaine sub-recall
FDA (Devices) · 2026-06-10
- SevereBD Whitacre spinal trays across nine catalog numbers recalled over bupivacaine
FDA (Devices) · 2026-06-10
- SevereBD spinal trays recalled as a sub-recall of Huons bupivacaine
FDA (Devices) · 2026-06-10
Same hazard · leakage
See all →- SevereDraeger VentStar Resus Neo Neonatal Breathing Circuit Recall
FDA (Devices) · 2026-10-07
- HighConvaTec Esteem Body Soft Convex Urostomy Pouches Recalled for Leakage
FDA (Devices) · 2026-08-26
- SevereStryker AHTO Tube Set Packaging Recalled for Handpiece Leaking
FDA (Devices) · 2026-08-12
- SevereMedtronic Perfusion Systems Recalls EOPA Elongated One-Piece Arterial Cannula Model 77522
FDA (Devices) · 2026-08-05
- HighICU Medical Recalls Hotline Fluid Warming Sets Due to Leakage Risk
FDA (Devices) · 2026-07-29
Similar recalls
- HighBecton Dickinson Recalls BD Vacutainer Plus SST Tubes Due to Stopper Defect
FDA (Devices) · 2018-06-13
- HighBD Connecta stopcock Port C may over thread rather than tightening
FDA (Devices) · 2026-06-24
- ModerateBD Max StaphSR Extraction Tube Sealing Defect Recall
FDA (Devices) · 2019-08-28
- HighBD Vacutainer K2 EDTA Blood Collection Tubes Recalled for Stopper Defect
FDA (Devices) · 2015-12-30
- SevereBD Vacutainer PLUS K2EDTA Tubes Recalled for Insufficient Additive
FDA (Devices) · 2016-01-06
- HighBD Vacutainer Blood Collection Tubes Recalled for Stopper Pullout Risk
FDA (Devices) · 2017-04-12