FDA-Device2026-03-04Class IIMISBRANDING
Edermy PIE PAK models P2HC-A, P2HC-S, P2HC recalled for lack of FDA clearance
What this means
Edermy LLC is recalling PIE PAK models P2HC-A, P2HC-S, and P2HC because they were sold without FDA 510(k) clearance, which is required before medical devices can be marketed in the U.S. The company distributed approximately 11,202 units nationwide. No injuries have been reported.
- Stop using the PIE PAK device immediately
- Contact Edermy LLC or your healthcare provider for return or replacement instructions
- Do not rely on this device for medical purposes until you receive further guidance
The agency's original wording
Hazard
Lack of 510K clearance
Intended for
All ages
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
11202 units
Manufactured in
115 Enterprise Dr Ste A, N/A, Pendergrass, GA, United States
Products
PIE PAK Models: P2HC-A, P2HC-S, P2HC
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1462-2026Want us to check the next one for you?
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