BEUDAMED
    FDA Recall Open, Classified

    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 · Initiated June 27, 2025

    Recall

    Recall Number
    Z-2331-2025
    Event Number
    97229
    Firm
    Spiggle & Theis Mt Gmbh Lagerstr. 11 Dieburg Germany
    FEI Number
    3002858762
    Product Code
    GDM
    Status
    Open, Classified
    Root Cause
    Under Investigation by firm
    Initiated
    June 27, 2025
    Posted
    August 15, 2025

    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.

    Action

    On June 27, 2025, the firm notified customers through a letter titled "Urgent safety information Recall Injection Needle". Customers were asked to identify and quarantine any affected product in stock. Customer service will assist customers in returning product and the firm will issue a credit upon receipt of the affected product.

    Distribution

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