PIE PAK Models: P2HC-A, P2HC-S, P2HC
FDA Recall #Z-1462-2026 — Class II — January 14, 2026
Product Description
PIE PAK Models: P2HC-A, P2HC-S, P2HC
Reason for Recall
Lack of 510K clearance
Recalling Firm
Edermy LLC — Pendergrass, GA
Classification
Class II — May cause temporary or medically reversible adverse health consequences.
Product Type
Devices
Product Quantity
11202 units
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.
Code Information
All Lots UDI:
Status
Ongoing
Voluntary / Mandated
Voluntary: Firm initiated