Class II
Medical Device Recall: PIE Trolley System Model: 2005
Edermy LLC · January 14, 2026
Reason for Recall
Lack of 510K clearance
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.
States Affected
NATIONWIDE
Quantity Affected
27 units
Source: FDA (openFDA Device Enforcement)
Recall number: Z-1461-2026
Status: ongoing
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