← Back to recalls
FDA DeviceClass IINotable

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

Date: 2026-03-04
Brand: Edermy LLC
Category: Medical Device
FDA Class: Class II

Description

Lack of 510K clearance

Hazard

Lack of 510K clearance

Remedy

11202 units

View original recall →
FDA Recall: PIE PAK Models: P2HC-A, P2HC-S, P2HC | RecallWatch