Recall
FDAHealthJanuary 14, 2026

Edermy LLC — PIE Trolley System Model: 2005

⚠️ Lack of 510K clearance

Is this relevant to me?

Geography
Nationwide
Source agency
FDA
Category
Health
Published
January 14, 2026

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.

What's affected?

Product
PIE Trolley System Model: 2005
Lot code
s

Additional details

All Lots

What should I do?

Recommended action

Class II recall. Voluntary: Firm initiated Quantity affected: 27 units.

View original FDA notice →

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