CLASS II ONGOING Device recall · Reported 9 Apr 2025 · FDA Enforcement Report

BD Connecta BD Luer-Lok recalled by Bd Switzerland Sarl

BD Switzerland Sarl is recalling BD Connecta BD Luer-Lok 360, distributed in 35 states. The recall was initiated on 20 Feb 2025 and the FDA has classified it as Class II.

Check your package

Lot, batch or date codesCatalog Number: 394910 UDI-DI code: 00382903949106 Lot Numbers: 4277968 4277973 4282451 4282461 4289801 4290582 4292904 4295848 4305108 4306700

Quantity recalled500 units

Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.

Recall details

Recall number: Z-1509-2025
FDA event ID: 96399
Recalling firm: BD Switzerland Sarl, Eysins
Classification: Class II
Status: Ongoing
Recall initiated: 20 Feb 2025
FDA classified: 2 Apr 2025
Reported: 9 Apr 2025
Type: Voluntary: Firm initiated
Customers notified by: Letter
Reason category: Other Reasons
Device type: Patient Monitors

Timeline

20 Feb 2025	Recall initiated by company
2 Apr 2025	Classified by FDA	+41 days
9 Apr 2025	Published in enforcement report	+7 days

Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.

Reason for recall

Due to specific lots of luer-lok devices were shipped to the U.S. market with an Outside US Instruction for Use (IFU)

Product as listed by the FDA

BD Connecta BD Luer-Lok 360, REF 394910 UDI-DI code: 00382903949106 Connecta¿ Plus 1 and Connecta¿ Plus 3 2-way and 3-way Stopcocks are control valves for use in IV. therapy and hemodynamic pressure monitoring.

Where it was distributed

U.S.: AK, AL, AR, AZ, CA, CO, FL, GA, IL, IN, KS, KY, LA, MA, MD, MI, MN, MO, MS, NC, NE, NJ, NM, NV, OH, OK, OR, PA, SC, TN. TX, UT, VA, WA, WV O.U.S.: N/A

Alaska Alabama Arkansas Arizona California Colorado Florida Georgia Illinois Indiana Kansas Kentucky Louisiana Massachusetts Maryland Michigan Minnesota Missouri Mississippi North Carolina

Questions about this recall

Why was it recalled?

Due to specific lots of luer-lok devices were shipped to the U.S. market with an Outside US Instruction for Use (IFU)

Which lots are affected?

Catalog Number: 394910 UDI-DI code: 00382903949106 Lot Numbers: 4277968 4277973 4282451 4282461 4289801 4290582 4292904 4295848 4305108 4306700

Where was it sold?

U.S.: AK, AL, AR, AZ, CA, CO, FL, GA, IL, IN, KS, KY, LA, MA, MD, MI, MN, MO, MS, NC, NE, NJ, NM, NV, OH, OK, OR, PA, SC, TN. TX, UT, VA, WA, WV O.U.S.: N/A

What should I do if I have it?

Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.

What does Class II mean?

Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.

Read the official FDA notice · Source record retrieved 26 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.

More recalls from BD Switzerland Sarl

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Reported	Class	Recall	Company	Reason	Where
23 Sep 2026Device	CLASS I	BD Alaris Pump Infusion Sets 10561554* recalled by BD Switzerland Sarl	BD Switzerland Sarl	Other	Nationwide
19 Aug 2026Device	CLASS II	Non-DEHP Minibore Extension Set RES ME2010 recalled	BD Switzerland Sarl	Sterility	26 states
8 Jul 2026Device	CLASS II	Medline 111 Gravity Set W/3 Needle Free Y-Sites recalled	BD Switzerland Sarl	Other	IL
24 Jun 2026Device	CLASS II	BD Connecta" BD Luer-Lok" recalled by Bd Switzerland Sarl	BD Switzerland Sarl	Foreign Material	39 states
3 Sep 2025Device	CLASS II	BD PhaSeal Injector Luer (N30C) recalled by Bd Switzerland Sarl	BD Switzerland Sarl	Packaging Defects	Nationwide

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