Recall Z-1462-2026— Edermy LLC

Name: FDA recall Z-1462-2026
Creator: U.S. Food and Drug Administration
Published: 2026-01-14

Class II · Ongoing

Class II FDA medical device recall by Edermy LLC, initiated 2026-01-14. FDA's recall record names no specific 510(k) clearance for this event. Product: PIE PAK Models: P2HC-A, P2HC-S, P2HC. Reason: Lack of 510K clearance.

Recalling firm: Edermy LLC
Classification: Class II
Status: Ongoing
Initiated: 2026-01-14
Firm location: Pendergrass, GA, United States

Product description

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

Reason for recall

Lack of 510K clearance

Data sourced from openFDA. This site is unofficial and independent of the FDA.