BD SWITZERLAND SARL: Medical Device Recall in 2025 - (Recall #: Z-1509-2025)

Updated on March 25, 2026.

See the recall detail below. You can also see other recalls from the same firm in 2025.

Data Source: FDA.
Product Description:

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.

Product Classification:

Class II

Date Initiated: February 20, 2025
Date Posted: April 9, 2025
Recall Number: Z-1509-2025
Event ID: 96399
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)

Status: Ongoing
Product Quantity: 500 units
Code Information:

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

Distribution Pattern:

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

Voluntary or Mandated:

Voluntary: Firm initiated