Pendergrass, GA, United States
Edermy LLC recalls
1 recall recorded since 2018, most recently on 14 January 2026. 1 is listed as ongoing. Status and classification are as published by the FDA.
Recalls1
Ongoing (FDA)1
Terminated or completed0
Class I (FDA)0
Ongoing Class II Medical devices
- Recall started
- 14 January 2026
- Reason
- Lack of 510K clearance
- Distribution
- 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.
- Initiated
- Voluntary: Firm initiated
- Recall numbers
- Z-1462-2026, Z-1461-2026
- PIE PAK Models: P2HC-A, P2HC-S, P2HC
- PIE Trolley System Model: 2005
A terminated FDA recall means the FDA has determined that all reasonable efforts to remove or correct the product have been made. What statuses mean.