Edermy LLC Issues Recall for PIE Trolley System Model 2005 Due to Lack of FDA Clearance
Edermy LLC is recalling 27 units of its PIE Trolley System Model 2005 because the device lacks the necessary 510(k) clearance from the FDA.
What Happened
Edermy LLC, based in Pendergrass, Georgia, has initiated a voluntary recall of the PIE Trolley System Model 2005. The recall was prompted by the discovery that the device lacks the required 510(k) clearance from the U.S. Food and Drug Administration (FDA). This regulatory clearance is necessary to demonstrate that a medical device is safe and effective for its intended use before being marketed.
Which Products Are Affected
The recall affects all lots of the following device:
- Product Name: PIE Trolley System
- Model Number: 2005
- Recall Number: Z-1461-2026
- Quantity: 27 units
The affected units were distributed across 18 states: Ohio, Arizona, Illinois, Pennsylvania, Indiana, California, Missouri, Massachusetts, Minnesota, Virginia, Florida, New York, Alabama, South Carolina, North Carolina, Tennessee, Texas, and Colorado.
What You Should Do
Consumers and healthcare providers in possession of the PIE Trolley System Model 2005 should identify any units from “All Lots” currently in their inventory. Edermy LLC initiated the notification process via email on January 14, 2026. For further instructions regarding the return or remediation of the device, contact Edermy LLC at their headquarters located at 115 Enterprise Dr Ste A, Pendergrass, GA 30567-4701.
Why This Matters
The 510(k) clearance process is a critical regulatory requirement that ensures medical devices are substantially equivalent to legally marketed devices. Using a device without this clearance means its safety and performance standards have not been formally validated by federal health authorities.
Source
Information provided by the FDA.
Source: FDA Official Notice