🔍 RecallPedia

PIE PAK Models: P2HC-A, P2HC-S, P2HC

Class I - Dangerous
🏥 Medical Devices Recalled: January 14, 2026 Edermy Other Medical Devices Nationwide

What Should You Do?

  1. Check if you have this product:
    All Lots UDI:
  2. Do not eat it: Even if it looks and smells fine, do not consume this product.
  3. Throw it away or return it: You can return the product to the store for a full refund.
  4. Seek medical attention if needed: If you've consumed this product and feel unwell, contact your doctor immediately.
  5. Report problems: Report any issues to the FDA's Safety Reporting Portal.

⚠️ Emergency: If you experience severe symptoms after consuming this product, call 911 or Poison Control at 1-800-222-1222.

Recall Details

Company:
Edermy LLC
Reason for Recall:
Lack of 510K clearance
Classification:
Class I - Dangerous

Dangerous or defective products that predictably could cause serious health problems or death.

Status:
ongoing

Product Information

Full Description:

PIE PAK Models: P2HC-A, P2HC-S, P2HC

Product Codes/Lot Numbers:

All Lots UDI:

Official Source

Always verify recall information with the official FDA source:

View on FDA.gov

FDA Recall Number: Z-1462-2026