← FDA ENFORCEMENT
Z-1461-2026Class II
Edermy LLC
What this record is not
A recall record is reproduced as FDA published it, and the classification is FDA’s. SPEQ adds no interpretation, and a recall concerns the products and dates in the record — it is not a statement about a company’s other products or its current status.
Recalling firm
Edermy LLC
Product type
Device
Status
Ongoing
Report date
2026-03-04
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.
Firm state
GA
Product quantity
27 units
Initiated by
Voluntary: Firm initiated
Reason for recall
Lack of 510K clearance
Product description
PIE Trolley System Model: 2005
Code / lot info
All Lots
Data: U.S. FDA. Recall details are as reported by the FDA. The quality-domain mapping and severity are a SPEQ editorial interpretation of the recall reason, not an official FDA classification. Open the enforcement explorer →