BEUDAMED
    FDA Enforcement Class II Ongoing

    PIE Trolley System Model: 2005

    Recall: Z-1461-2026 · Reported March 4, 2026

    Enforcement

    Recall Number
    Z-1461-2026
    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 Trolley System Model: 2005

    Reason

    Lack of 510K clearance

    Code Info

    All Lots

    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

    27 units