BEUDAMED
    FDA Enforcement Class II Ongoing

    PIE PAK Models: P2HC-A, P2HC-S, P2HC

    Recall: Z-1462-2026 · Reported March 4, 2026

    Enforcement

    Recall Number
    Z-1462-2026
    Event ID
    98303
    Classification
    Class II
    Status
    Ongoing
    Product Type
    Devices
    Firm
    Edermy LLC
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    E-Mail
    Report Date
    March 4, 2026
    Initiation Date
    January 14, 2026
    Classification Date
    February 24, 2026
    Address
    115 Enterprise Dr Ste A, N/A, Pendergrass, GA, 30567-4701, United States

    Description

    PIE PAK Models: P2HC-A, P2HC-S, P2HC

    Reason

    Lack of 510K clearance

    Code Info

    All Lots UDI:

    Distribution

    US Nationwide distribution in the states of OH, AZ, IL, PA, IN, CA, MO, MA, MN, VA, FL, NY, AL, SC, NC, TN, TX, CO.

    Quantity

    11202 units