Edermy
2 federal recalls on file. We monitor every CPSC, FDA, USDA, and NHTSA notice for Edermy and translate it into plain English — free weekly digest, optional same-day alerts.
- 2026-03-04FDA-DeviceClass IIStop using Edermy PIE PAK devices
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.
- 2026-03-04FDA-DeviceClass IIStop using Edermy PIE Trolley System Model 2005
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.
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