Edermy LLC recalls PIE PAK
- Recalling company
- Edermy LLC
- Product
- PIE PAK Models: P2HC-A, P2HC-S, P2HC
- Reason
- Lack of 510K clearance
- Classification
- Class II – may cause temporary or medically reversible health consequences
- Recall date
- Jan 14, 2026
- Reported
- Mar 4, 2026
- 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.
- Status
- Ongoing
- Quantity
- 11202 units
- Lot / codes
- All Lots UDI:
- Company location
- Pendergrass, GA
- Recall type
- Voluntary: Firm initiated
- Recall number
- Z-1462-2026
- Agency
- U.S. Food and Drug Administration (FDA)
View official FDA notice ↗ Search recall number Z-1462-2026 in the FDA Enforcement Report. Also see FDA recall press releases.
If you use this product, check the lot, NDC or model number against the official notice and follow its instructions. Do not stop a prescribed medicine or remove a medical device without talking to your doctor or pharmacist. Report problems to FDA MedWatch. FoodRecallNow summarizes public FDA data and is not medical advice.