BEUDAMED
    FDA Enforcement Class I Ongoing

    MicroMyst Applicator, Box of 5. Consisting of a multilumen applicator and filtered line for use with the Integra Flow Source for the controlled application of two liquids.

    Recall: Z-1961-2025 · Reported July 2, 2025

    Enforcement

    Recall Number
    Z-1961-2025
    Event ID
    96965
    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 23, 2025
    Classification Date
    June 20, 2025
    Address
    1100 Campus Rd, Princeton, NJ, 08540-6650, United States

    Description

    MicroMyst Applicator, Box of 5. Consisting of a multilumen applicator and filtered line for use with the Integra Flow Source for the controlled application of two liquids.

    Reason

    Lack of sterility assurance.

    Code Info

    Model/Catalog Number: 205000DS; UDI No. 10381780000112; All lots.

    Distribution

    Worldwide distribution - US Nationwide and the countries of Taiwan (Province of China), Viet Nam, Brazil, Trinidad and Tobago, El Salvador, South Korea, Peru, Canada, Australia, New Zealand, Belgium, France, Germany, Ireland, Israel, Italy, Kenya, Slovenia, South Africa, Spain, Sweden, Switzerland and United Kingdom.

    Quantity

    4,882 units