FDA recall Z-1462-2026
Edermy LLC · Class II · device
Product
PIE PAK Models: P2HC-A, P2HC-S, P2HC
Reason for recall
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.
Key facts
- Status
- Ongoing
- Initiation date
- 2026-01-14
- Report date
- 2026-03-04
- Voluntary/Mandated
- Voluntary: Firm initiated
- Location
- Pendergrass, GA, United States
Primary source
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1462-2026