HIGHFDA DEVICE

BD Connecta" BD Luer-Lok" 360 REF 394910 UDI-DI code: 00382903949106 BD Connecta" Stopcocks are used to administer fluids or medication through one or two different ports via an IV cannula or...

Due to stopcock issues when using the plastic luer-lok syringe, the connection at the Port C may over thread or continue to spin rather than tightening securely. This behavior has led some clinical users to perceive the connection as unstable.

BD SWITZERLAND SARLHealth & Personal CareMedical DevicesCatalog/Model Number: 394910 UDI-DI code: 00382903949106 Lot Numbers: 4277968 4277973 4282451 4282461 4289801 4290582 4292904 4295848 4299949 4303841 4305108 4306700 5129635 5129642 5129649 5129650 5129651 5139250 5139251 5139252 5150181 5153940 5164061 5164062 5178078 5181442 5183810 5183816 5183824 5183828 5218287 5218291 5218293 5218299 5218302 5241476 5247729 5247731 5251098 5275601 5275602

Source-backed recall notice

No product image was available from the source feed.

Official source
FDA DEVICE
Recall date
May 21, 2026
Status
ACTIVE

Quick Facts at a Glance

Recall Date
May 21, 2026
Hazard Level
HIGH
Brand
BD SWITZERLAND SARL
Geographic Scope
Nationwide (50 states)

What to Do Now

Use this page like a recall checklist: verify the product first, then act on the official remedy.

Immediate steps

  1. 1Stop using the product until you confirm whether it is included in the recall.
  2. 2Compare the product label, model number, UPC, color, size, and purchase location against the identifiers below.
  3. 3Follow the official remedy from FDA - Medical Devices; save photos, receipts, labels, and correspondence before contacting the company.
  4. 4If the product could harm a child, older adult, pet, or patient, move it out of reach immediately.

Check these identifiers

Brand
BD SWITZERLAND SARL
Model numbers
Catalog/Model Number: 394910 UDI-DI code: 00382903949106 Lot Numbers: 4277968 4277973 4282451 4282461 4289801 4290582 4292904 4295848 4299949 4303841 4305108 4306700 5129635 5129642 5129649 5129650 5129651 5139250 5139251 5139252 5150181 5153940 5164061 5164062 5178078 5181442 5183810 5183816 5183824 5183828 5218287 5218291 5218293 5218299 5218302 5241476 5247729 5247731 5251098 5275601 5275602
Where affected
Nationwide

Recall Timeline

Key dates and source checks for this recall record.

  1. Recall announced

    May 21, 2026

  2. Reported by FDA DEVICE

    June 24, 2026

  3. RecallRadar source check

    June 30, 2026

  4. Consumer action

    Use the official remedy and keep documentation.

Hazard Information

Due to stopcock issues when using the plastic luer-lok syringe, the connection at the Port C may over thread or continue to spin rather than tightening securely. This behavior has led some clinical users to perceive the connection as unstable.

What You Should Do

Patients and healthcare providers should stop using this device immediately. Follow the recall instructions provided by the manufacturer. Contact BD SWITZERLAND SARL or your healthcare provider for instructions. Notification method: Letter

Get instant alerts for BD SWITZERLAND SARL recalls

Be the first to know. Free instant alerts to your inbox.

No spamUnsubscribe anytime

Full Description

BD Connecta" BD Luer-Lok" 360 REF 394910 UDI-DI code: 00382903949106 BD Connecta" Stopcocks are used to administer fluids or medication through one or two different ports via an IV cannula or extension tube. The ports can be used to sample blood or for hemodynamic monitoring. When used with IV lipid nutritional products, the stopcock device can be used for up to 24 hours.. Reason: Due to stopcock issues when using the plastic luer-lok syringe, the connection at the Port C may over thread or continue to spin rather than tightening securely. This behavior has led some clinical users to perceive the connection as unstable.. Classification: Class II. Quantity: 2,465,500 units. Distribution: U.S.: AK, AL, AR, AZ, CA, CO, DC, FL, GA, IA, IL, IN, KS, KY, LA, MA, MD, MI, MN, MO, MS, NC, NE, NJ, NM, NY, OH, OK, OR, PA, SC, SD, TN, TX, UT, VA, WA, WI, and WV. O.U.S.: Japan

Safety Guide

Not sure what to do next? Our guide walks you through the process step by step.

Read: How to Get Refunds and Replacements

Want to Know First?

Get instant alerts for recalls that affect you. Free forever.

Product Classification

Product Details

Model Numbers
Catalog/Model Number: 394910 UDI-DI code: 00382903949106 Lot Numbers: 4277968 4277973 4282451 4282461 4289801 4290582 4292904 4295848 4299949 4303841 4305108 4306700 5129635 5129642 5129649 5129650 5129651 5139250 5139251 5139252 5150181 5153940 5164061 5164062 5178078 5181442 5183810 5183816 5183824 5183828 5218287 5218291 5218293 5218299 5218302 5241476 5247729 5247731 5251098 5275601 5275602
Affected States
Nationwide
Report Date
June 24, 2026
Recall Status
ACTIVE