Z-1462-2026 Class II Ongoing
FDA device recall Z-1462-2026 was initiated by Edermy LLC on January 14, 2026 and is designated Class II. Reason for recall: Lack of 510K clearance The recall status is ongoing. Affected quantity: 11202 units.
Recall Details
- Product Type
- Devices
- Report Date
- March 4, 2026
- Initiation Date
- January 14, 2026
- Termination Date
- N/A
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 11202 units
Product Description
PIE PAK Models: P2HC-A, P2HC-S, P2HC
Reason for Recall
Lack of 510K clearance
Distribution Pattern
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.
Code Information
All Lots UDI: