FDA DevicesClass II
PIE PAK Models: P2HC-A, P2HC-S, P2HC
Published: March 4, 2026Recall ID: Z-1462-2026Category: devicesCountry: US
Reason for Recall / Hazard
Lack of 510K clearance
Product Description & Identification
PIE PAK Models: P2HC-A, P2HC-S, P2HC
Affected Products
PIE PAK Models: P2HC-A, P2HC-S, P2HC
Additional Source Details
| Field | Value |
|---|---|
| City | Pendergrass |
| State | GA |
| Event id | 98303 |
| Address 1 | 115 Enterprise Dr Ste A |
| Address 2 | N/A |
| Code info | All Lots UDI: |
| Postal code | 30567-4701 |
| Report date | 20260304 |
| Product type | Devices |
| Product quantity | 11202 units |
| Reason for recall | Lack of 510K clearance |
| Voluntary mandated | Voluntary: Firm initiated |
| Recall initiation date | 20260114 |
| Initial firm notification | |
| Center classification date | 20260224 |
Overview
- Recalling FirmEdermy LLC
- StatusOngoing
- Risk LevelClass II
- DistributionUS Nationwide distribution in the states of OH, AZ, IL, PA, IN, CA, MO, MA, MN, VA, FL, NY, AL, SC, NC, TN, TX, CO.