Skip to main content

Ongoing FDAEvent 98855 (3 months ago)

BD Connecta Stopcocks

BD Connecta BD Luer-Lok 360 Stopcocks may have an unstable connection at Port C when used with a plastic luer-lok syringe.

Moderate risk

Using it may cause temporary or medically reversible health problems. Serious harm is unlikely.

FDA Class II recall · How risk is rated

What to do

What happened

BD SWITZERLAND SARL is recalling BD Connecta BD Luer-Lok 360 Stopcocks because, when used with a plastic luer-lok syringe, the connection at Port C may over thread or continue to spin rather than tightening securely, leading some clinical users to perceive the connection as unstable. The recall began May 21, 2026, and was added to the FDA's Enforcement Report on June 18, 2026.

The stopcocks are used to administer fluids or medication through one or two different ports via an IV cannula or extension tube, and 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. The product was distributed in the U.S. and Japan. The company began the recall on May 21, 2026.

Summary by Recall Canary from the FDA notice.

What to do

We don't have product-specific instructions for this recall. FDA's general advice for medical device recalls:

  1. A device recall doesn't always mean you must stop using it: it may need to be checked, adjusted or fixed.
  2. Talk to your health care provider before you stop using it.

Is yours affected?

Match the UDI-DI and lot code listed under your product.

Incomplete list: 40 of 41 lot codes shown.

  1. BD Connecta" BD Luer-Lok" 360 REF 394910 UDI-DI code: 00382903949106 BD Connecta" Stopcocks

    UDI-DI
    • 00382903949106
    Lot
    • 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

Details

Company began the recall
Event ID
98855
Recall No.
Z-2514-2026
Company
BD SWITZERLAND SARLEysins, Switzerland
Quantity recalled
2,465,500 units
Recall type
Voluntary: Firm initiated
Customers told by
Letter
  1. Company began the recall

  2. Added to FDA's Enforcement Report · Classified by FDA

  3. Listed on Recall Canary

  4. In FDA's weekly enforcement report

  5. Summary updated

All recalls from BD SWITZERLAND SARL

Summary by Recall Canary, written with AI · summary updated Oct 3, 2026 · primary source: U.S. Food and Drug Administration