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Edermy LLC recalls PIE PAK Models: P2HC-A, P2HC-S, P2HC
Recalled March 4, 2026 · FDA recall Z-1462-2026 · Edermy
Hazard
Lack of 510K clearance · FDA Class II
Units
11202 units
Sold at
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.
Description
Lack of 510K clearance
Product
PIE PAK Models: P2HC-A, P2HC-S, P2HC
Manufacturer(s)
Edermy LLC
Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →