BEUDAMED
    FDA Enforcement Class II Ongoing

    Injection needle, bayonet, Luer-Lock, 1. Model no. 50-353-23, working length 25 cm, total length 31cm, nonsterile; 2. Model no. 50-345-23, working length 24 cm, total length 31 cm, non-sterile

    Recall: Z-2331-2025 · Reported August 27, 2025

    Enforcement

    Recall Number
    Z-2331-2025
    Event ID
    97229
    Classification
    Class II
    Status
    Ongoing
    Product Type
    Devices
    Firm
    Spiggle & Theis Mt Gmbh
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    N/A
    Report Date
    August 27, 2025
    Initiation Date
    June 27, 2025
    Classification Date
    August 15, 2025
    Address
    Lagerstr. 11, N/A, Dieburg, N/A, N/A, Germany

    Description

    Injection needle, bayonet, Luer-Lock, 1. Model no. 50-353-23, working length 25 cm, total length 31cm, nonsterile; 2. Model no. 50-345-23, working length 24 cm, total length 31 cm, non-sterile

    Reason

    Affected product show elevated cytotoxicity values. Use of affected injection needles may present a risk of intolerance reaction or allergic reaction.

    Code Info

    1. Model No 50-353-23; UDI-DI 04250381858806; LOT (0)2241239 2. Model No 50-345-23; UDI-DI 04250381858813; LOT 2230438; LOT 2240251

    Distribution

    US Nationwide distribution in the states of California, Connecticut, Missouri, and Ohio.

    Quantity

    N/A