Recall Atlas
Drugs & medicalClass II

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

Lack of 510K clearance

Read the official notice →
Date
2026-03-04
Country
United States
Brand
Edermy LLC
Product
PIE PAK Models: P2HC-A, P2HC-S, P2HC
Classification
Class II
Units
US Nationwide distribution in the states of OH, AZ, IL, PA, IN, CA, MO, MA,…
Category
Drugs & medical
Source
FDA · Device

Copied automatically from the US Food and Drug Administration. Details may be shortened or out of date; the official notice is the authoritative source. Disclaimer

What to do

  1. Check the product name, strength and lot number against the official notice.
  2. Do not stop a prescribed medicine without talking to your doctor or pharmacist first.
  3. Ask the pharmacy or supplier about a replacement or refund.

General guidance from Recall Atlas. The official notice from the US Food and Drug Administration has the exact models, batch codes and remedy, and it takes priority.

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