Class II — Potential Health Hazard

Potential health hazard — use of or exposure to this product may cause temporary or medically reversible adverse health consequences.

PIE PAK Models: P2HC-A Recalled by Edermy LLC Due to Lack of 510K clearance

Date: January 14, 2026
Company: Edermy LLC
Status: Ongoing
Source: FDA (Device)

What You Should Do

Stop using this product immediately. Do not consume, use, or distribute it.

Return the product to the place of purchase for a full refund. If you have questions, contact Edermy LLC directly.

Affected Products

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

Quantity: 11202 units

Why Was This Recalled?

Lack of 510K clearance

Where Was This Sold?

This product was distributed nationwide across all 50 states.

Affected (51 states)Not affected

About Edermy LLC

Edermy LLC has 2 total recalls tracked by RecallDetector.

Related Recalls

Data sourced from the FDA (Device). Last updated March 26, 2026. View original report