FDA-Device2026-03-04Class IIMISBRANDING
Edermy PIE Trolley System Model 2005 recalled for lack of FDA clearance
What this means
Edermy LLC's PIE Trolley System Model 2005 was distributed without required FDA 510(k) clearance, which means the device was not reviewed or approved for safety and effectiveness. The FDA has issued a recall affecting 27 units distributed across multiple states.
- Stop using the PIE Trolley System Model 2005 immediately
- Contact Edermy LLC or the place of purchase for instructions on return or replacement
- Do not use this device until it receives proper FDA clearance
The agency's original wording
Hazard
Lack of 510K clearance
Intended for
Adults
Illnesses reported
None reported
Sold states
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.
Affected count
27 units
Manufactured in
115 Enterprise Dr Ste A, N/A, Pendergrass, GA, United States
Products
PIE Trolley System Model: 2005
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1461-2026Want us to check the next one for you?
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