The Recall Desk
ModerateFDA (Devices)·Z-1462-2026·Announced 2026-03-04

Edermy PIE PAK units recalled for lacking FDA 510(k) clearance

Edermy LLC is recalling PIE PAK models P2HC-A, P2HC-S and P2HC because the devices lack 510(k) clearance from the FDA.

What this means for you

Minor labeling or packaging issue, or a voluntary precautionary recall. Risk of harm is low but real — follow the manufacturer's instructions.

Our severity reasoning: Rubric level 2 covers voluntary precautionary recalls: the recall is for a missing regulatory clearance and the source describes no defect, malfunction or hazard in the device.

Plain-English summary

Edermy LLC is recalling the PIE PAK, models P2HC-A, P2HC-S and P2HC. About 11,202 units were distributed in Ohio, Arizona, Illinois, Pennsylvania, Indiana, California, Missouri, Massachusetts, Minnesota, Virginia, Florida, New York, Alabama, South Carolina, North Carolina, Tennessee, Texas and Colorado. The FDA has classified this recall as Class II.

The recall was initiated for lack of 510(k) clearance. The source record does not describe a defect or malfunction in the device itself.

All lots are affected.

Facilities can identify affected devices by the model numbers above, and may contact Edermy LLC for further information.

The recalled product

Product
PIE PAK Models: P2HC-A, P2HC-S, P2HC
Manufacturer
Edermy LLC
Category
Medical Device — Regulatory
Hazard
  • missing-510k
  • regulatory-recall

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.

Related recalls

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