BD Connecta Stopcock Without Extension Tube Recalled for Potential Leakage Risk
Becton Dickinson & Company is recalling BD Connecta Stopcock units worldwide due to a potential housing leakage defect that could interrupt treatment or cause exposure 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 a Class II medical device with potential for leakage that could cause treatment interruption, exposure to biohazardous material, and underdosing. No illnesses or injuries have been reported, making this a risk-of-harm product where injury has not yet occurred.
Plain-English summary
BD Connecta Stopcock Without Extension Tube (Catalog No. 394605) manufactured by Becton Dickinson & Company is being recalled worldwide. The device may develop a leakage at the housing component, potentially resulting in treatment interruption, exposure to infusate and biohazardous material, underdosing, contamination, and air ingress.
The recall affects units distributed nationwide in the United States and internationally in Belgium, China, India, Indonesia, Japan, Korea, Nepal, Philippines, Singapore, Sri Lanka, Thailand, and Vietnam. Affected lot numbers have expiration dates ranging from January to April 2024.
The recalled product
- Product
- BD Connecta Stopcock Without Extension Tube Catalog No. 394605 (OUS)
- Manufacturer
- Becton Dickinson & Company
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
- ModerateBD Max StaphSR Extraction Tube Sealing Defect Recall
FDA (Devices) · 2019-08-28
- ModerateBD MAX Reagent Extraction Tubes Recalled for Improper Sealing
FDA (Devices) · 2019-08-28
- HighBecton Dickinson Recalls BD Microtainer Z Tubes Due to Damaged Reservoirs
FDA (Devices) · 2019-10-16
- ModerateBD Max ExK DNA 2 USA Extraction Tube Sealing Defect Recall
FDA (Devices) · 2019-08-28
- HighBD Microtainer Tubes Recalled for Damaged Reservoirs Causing Test Errors
FDA (Devices) · 2019-10-16