Edermy LLC recalls PIE PAK Models: P2HC-A, P2HC-S, P2HC

Recall date

January 14, 2026

Source

U.S. Food & Drug Administration (FDA) — enforcement report

Recall number

Z-1462-2026

FDA classification

Class II

Brand / firm

Edermy LLC

Sold / distributed

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.

Why it was recalled

Lack of 510K clearance

Class II means using this product may cause temporary or medically reversible health problems; the chance of serious harm is remote.

What was recalled

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