FDAHealthJanuary 14, 2026
Edermy LLC — PIE PAK Models: P2HC-A, P2HC-S, P2HC
⚠️ Lack of 510K clearance
Is this relevant to me?
- Geography
- Nationwide
- Source agency
- FDA
- Category
- Health
- Published
- January 14, 2026
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.
What's affected?
- Product
- PIE PAK Models: P2HC-A, P2HC-S, P2HC
- Brand
- Edermy LLC
- Lot code
- UDI:
Additional details
All Lots UDI:
What should I do?
Recommended action
Class II recall. Voluntary: Firm initiated Quantity affected: 11202 units.
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