Edermy recalls PIE PAK models P2HC-A, P2HC-S, and P2HC due to lack of 510K clearance. Affected units may not meet regulatory safety standards.
Lack of 510K clearance
Edermy is recalling PIE PAK models P2:HC-A, P2HC-S, and P2HC because they lack 510K clearance. This means the products may not meet regulatory safety standards, though the specific risk isn't detailed in the recall notice.
The recall mentions a 'lack of 510K clearance,' which refers to regulatory approval in the U.S. medical device context. Without this clearance, the products may not meet safety standards, but the exact hazard isn't specified in the recall notice.
Owners of PIE PAK models P2HC-A, P2HC-S, and P2HC are affected. Most at risk are users who have these specific models.
Check for PIE PAK models labeled P2HC-A, P2HC-S, or P2HC. The recall covers all lots with these model numbers.
Identify if your PIE PAK model is P2HC-A, P2HC-S, or P2HC.
The recall states a 'lack of 510K clearance,' which means the products may not meet regulatory safety standards, but the specific hazard isn't detailed in the notice.
The recall does not specify a remedy or action to stop use, so there is no immediate need to stop using them.
Check the model number on your PIE PAK; affected models are P2HC-A, P2HC-S, and P2HC.
We’ve drafted a message you can send Edermy to request your refund or repair — edit it as you like.
Subject: Recall Z-1462-2026 — Edermy Edermy Hello, I own a Edermy that is covered by recall Z-1462-2026 from Edermy. I’m writing to arrange the remedy described in the recall (a refund, repair, or replacement as applicable). Could you please tell me the next steps to resolve this? Thank you.
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The facts (hazard, remedy, dates, manufacturer) are pulled from the official FDA recall record. The plain-language summary and step-by-step checklist are written by GovInfoNow to make the official notice easier to act on — they don’t replace it.
