BEUDAMED
    FDA Enforcement Class II Ongoing

    Private Label CVS. Model Number: CVS405406. Helps maintain a moist wound environment, which has shown to be conducive to wound healing. Intended for minor scalds & burns, minor cuts, lacerations & minor abrasions.

    Recall: Z-1365-2026 · Reported February 25, 2026

    Enforcement

    Recall Number
    Z-1365-2026
    Event ID
    98175
    Classification
    Class II
    Status
    Ongoing
    Product Type
    Devices
    Firm
    Integra LifeSciences Corp. (NeuroSciences)
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit
    Report Date
    February 25, 2026
    Initiation Date
    January 16, 2026
    Classification Date
    February 13, 2026
    Address
    1100 Campus Rd, Princeton, NJ, 08540-6650, United States

    Description

    Private Label CVS. Model Number: CVS405406. Helps maintain a moist wound environment, which has shown to be conducive to wound healing. Intended for minor scalds & burns, minor cuts, lacerations & minor abrasions.

    Reason

    Potential packaging failures, which could lead to a breach in the sterile barrier.

    Code Info

    Model Number: CVS405406; UDI-DI: 00050428452547; Lot Numbers: 2428, 2446, 2509, 2514.

    Distribution

    Worldwide - US Nationwide distribution in the states of TX, MI, FL, IN, MO, CA, VA, NJ, PA, SC, TN, RI, NY and the countries of Australia, Austria, Bahrain, Canada, Finland, France, Germany, Greece, Guam, Guernsey, Hungary, Iran (Islamic Republic of), Iraq, Ireland, Israel, Italy, Korea (the Republic of), Kuwait, Lebanon, Madagascar, Malaysia, Netherlands (the), New Zealand, Norway, Poland, Portugal, Romania, Saudi Arabia, Serbia, Slovenia, Spain, Switzerland, Tunisia, Uganda, United Arab Emirates (the), United Kingdom of Great Britain and Northern Ireland (the), Virgin Islands (U.S.).

    Quantity

    2,906 units