BEUDAMED
    FDA Enforcement Class II Ongoing

    DeRoyal Industries Inc. Ref 46-406, Covaderm Plus, Vascular Access Dressing 6"x6" (15cmx15cm)

    Recall: Z-2305-2026 · Reported June 10, 2026

    Enforcement

    Recall Number
    Z-2305-2026
    Event ID
    99044
    Classification
    Class II
    Status
    Ongoing
    Product Type
    Devices
    Firm
    DeRoyal Industries Inc
    Voluntary / Mandated
    Voluntary: Firm initiated
    Report Date
    June 10, 2026
    Initiation Date
    May 18, 2026
    Classification Date
    June 3, 2026
    Address
    200 Debusk Ln, Powell, TN, 37849-4703, United States

    Description

    DeRoyal Industries Inc. Ref 46-406, Covaderm Plus, Vascular Access Dressing 6"x6" (15cmx15cm)

    Reason

    Sterile wound dressing, lacks sterility assurance

    Code Info

    Lot: 63295141/UDI: None

    Distribution

    US Nationwide distribution in the states of FL & NC.

    Quantity

    800 units