[pending] PIE PAK Models: P2HC-A, P2HC-S, P2HC
Pending LLM rewrite. Source: FDA_DEVICE Z-1462-2026.
What this means for you
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: Pending LLM scoring against the rubric.
Plain-English summary
Lack of 510K clearance
The recalled product
- Product
- PIE PAK Models: P2HC-A, P2HC-S, P2HC
- Manufacturer
- Edermy LLC
- Category
- Medical Device — Devices
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (1)
- All Lots UDI:
Distribution
Distributed nationwide across the United States.
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