Class II

Medical Device Recall: PIE PAK Models: P2HC-A, P2HC-S, P2HC

Edermy LLC · January 14, 2026

Reason for Recall

Lack of 510K clearance

Distribution

US Nationwide distribution in the states of OH, AZ, IL, PA, IN, CA, MO, MA, MN, VA, FL, NY, AL, SC, NC, TN, TX, CO.

States Affected

NATIONWIDE

Quantity Affected

11202 units

Source: FDA (openFDA Device Enforcement)

Recall number: Z-1462-2026

Status: ongoing

SafeCheck provides drug interaction information from FDA-approved product labeling (openFDA). This is for informational purposes only and is not medical advice. Always consult your healthcare provider before making medication decisions.