Z-1462-2026 Class II Ongoing
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: