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FDARecall

[Recall] Edermy LLC — PIE Trolley System Model: 2005 — Lack of 510K clearance

Feb 24, 2026

Published: 2026-02-24Captured: 2026-03-01Edermy LLCProduct: PIE Trolley System Model: 2005Product 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.

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