Back to search

FDARecall

[Recall] Edermy LLC — PIE PAK Models: P2HC-A — Lack of 510K clearance

Feb 24, 2026

Published: 2026-02-24Captured: 2026-03-01Edermy LLCProduct: PIE PAK Models: P2HC-A, P2HC-S, P2HCProduct Code: KPL

FDA device recall (Open, Classified). Edermy LLC: Lack of 510K clearance.

•Firm: Edermy LLC
•Status: Open, Classified
•Root cause: No Marketing Application
•Action: On January 14, 2026 PieMed issued a Urgent: Medical Device Recall Notification to affected consig...

Reason:Lack of 510K clearance

Root Cause:No Marketing Application

Action

On January 14, 2026 PieMed issued a Urgent: Medical Device Recall Notification to affected consignees via mail. PieMed asked consignees to take the following actions: 1. Discontinue use of the PIE ...

Status:Open, Classified

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.

View Sourcebd9b51c3…