BEUDAMED
    FDA Recall Open, Classified

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

    Recall: Z-1462-2026 · Initiated January 14, 2026

    Recall

    Recall Number
    Z-1462-2026
    Event Number
    98303
    Firm
    Edermy LLC
    FEI Number
    1000511598
    Product Code
    KPL
    Status
    Open, Classified
    Root Cause
    No Marketing Application
    Initiated
    January 14, 2026
    Posted
    February 24, 2026
    Address
    115 Enterprise Dr, Ste A, Pendergrass, GA, 30567-4701

    Description

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

    Reason

    Lack of 510K clearance

    Action

    On January 14, 2026 PieMed issued a Urgent: Medical Device Recall Notification to affected consignees via mail. PieMed asked consignees to take the following actions: 1. Discontinue use of the PIE 2005 Trolley System and PIE PAK Components. 2. Secure and retain the PIE 2005 Trolley System and any unused PIE PAK kits in a controlled location to prevent further use. 3. Consult with a healthcare provider regarding continuation of care and alternative treatment options, as appropriate. 4. You may complete acknowledgement and receipt form in 2 weeks. 5. Please ensure this notification is provided to all affected individuals. If the device has been transferred to a different location, please ensure they are provided with a copy of the communication. 6. No further action should be taken with the affected device(s) unless directed by PIEMed.

    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