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Recall Observatory FDA recall evidence

Device product

PIE Trolley System Model: 2005

Z-1461-2026

January 14, 2026

Class II

Product summary

Firm
Edermy LLC
Event
Event 98303
Status
Ongoing
Classification
Class II
Quantity
27 units
Official record key
device-enforcement:Z-1461-2026

Official wording

Reason: Lack of 510K clearance

Code information: All Lots

Distribution pattern: 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.

Derived failure modes

  • Unknown

    reason.no_named_rule · v1.0.0

    Lack of 510K clearance