Medical device recalls Moderate risk

Edermy LLC recalls PIE Trolley System Model: 2005

Recall date
January 14, 2026
Source
U.S. Food & Drug Administration (FDA) — enforcement report
Recall number
Z-1461-2026
FDA classification
Class II
Brand / firm
Edermy LLC
Sold / distributed
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.

Why it was recalled

Lack of 510K clearance

Class II means using this product may cause temporary or medically reversible health problems; the chance of serious harm is remote.

What was recalled

PIE Trolley System Model: 2005

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