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.
What this means for you
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
- Affected units
- 2,100,210
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 →- 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
- SevereABIOMED Introducer Kit 23 Fr heart pump accessory leakage risk
FDA (Devices) · 2026-07-22