PIE PAK recall
PIE PAK Models: P2HC-A, P2HC-S, P2HC
Why was PIE PAK recalled?
Lack of 510K clearance
What should I do if I have this product?
The recall is ongoing. Follow the firm and FDA instructions.
What to do with a recalled product: refunds, receipts, safe disposal and how to report a problem.
Is my product affected?
Compare the item in your hand with every identifier below from the official FDA record. Only products that match the listed product and lot, UPC or model codes are part of this recall.
Which lot codes, UPCs or models are affected?
All Lots UDI:
- Product
- PIE PAK Models: P2HC-A, P2HC-S, P2HC
- Recalling firm
- Edermy LLC
- Quantity
- 11202 units
- 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.
- Recall date
- March 4, 2026
- Classification
- Class II
- Status
- Ongoing
- Agency
- FDA (device)