Class IIReported 2026-03-04

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

Recalled by Edermy LLC

Reason for Recall

Lack of 510K clearance

Recall Number

Z-1462-2026

Classification

Class II

Status

Ongoing

Category

device

Initiated

2026-01-14

Reported

2026-03-04

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.

Code Info

All Lots UDI:

Source: openFDA enforcement report. WhichRecall is not affiliated with the FDA. See our disclaimer.