Reported Mar 4, 2026 · Ongoing
PIE PAK Models: P2HC-A, P2HC-S, P2HC
Edermy LLC
Moderate riskThis product could cause temporary or reversible health problems — stop using it.What you should do
Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.
Firm contact: Edermy LLC · 115 Enterprise Dr Ste A · Pendergrass, GA · 30567-4701
Is this the product you have?
- PIE PAK Models
P2HC-AP2HC-SP2HC
- Lot codes and dates
- All Lots UDI—
- Amount recalled
- 11202 units
This recall covers 2 products
The agency filed one notice per product. You are reading one of them; the other one is below.
Where it was sold
Why it was recalled
Lack of 510K clearance
This product could cause temporary or reversible health problems — stop using it.
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The guide adds the identifying codes laid out for scanning, symptoms to watch for, a timeline, and news coverage of this recall.
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