BEUDAMED
    FDA Enforcement Class I Ongoing

    Extended Tip Applicator 8CM, Box of 1.

    Recall: Z-1960-2025 · Reported July 2, 2025

    Enforcement

    Recall Number
    Z-1960-2025
    Event ID
    96934
    Classification
    Class I
    Status
    Ongoing
    Product Type
    Devices
    Firm
    Integra LifeSciences Corp. (NeuroSciences)
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Letter
    Report Date
    July 2, 2025
    Initiation Date
    May 22, 2025
    Classification Date
    June 20, 2025
    Address
    1100 Campus Rd, Princeton, NJ, 08540-6650, United States

    Description

    Extended Tip Applicator 8CM, Box of 1.

    Reason

    Devices contain potentially out-of-specification levels of endotoxins and lack of sterility assurance.

    Code Info

    Model/Catalog Number: 201108; UDI 10381780000167; All Lots.

    Distribution

    Domestic: Nationwide Distribution; Foreign: Canada, Japan, Australia, New Zealand, Taiwan (Province of China), Mexico, Colombia, Dominican Republic (the), Singapore, Mongolia, Hong Kong, Chile, Argentina, Puerto Rico, El Salvador, Guatemala, Korea (the Republic of), Peru, Costa Rica, Panama, From Belgium, distributed to: Austria, Belgium, Cyprus, Czechia, France, Georgia, Germany, Greece, Hungary, Iran (Islamic Republic of), Ireland, Italy, Jordan, Malta, Netherlands (the), Nigeria, Palestine, State of, Portugal, Romania, Saudi Arabia, South Africa, Spain, Sweden, Switzerland, Turkey.

    Quantity

    212 units