FDA recall, , Moderate risk
PIE PAK and Trolley System
The PIE Trolley System lacks 510K clearance.
Summary by Recall Canary from the FDA notice
What happened
Edermy LLC of Pendergrass, Georgia, began a recall on January 14, 2026, of its Pie Pak Models P2HC-A, P2HC-S, and P2HC, and the PIE Trolley System Model 2005, because the products lack 510K clearance. The FDA added the recall to its Enforcement Report and classified it on February 24, 2026, with the weekly report on March 4, 2026.
The products were distributed nationwide in states including Alabama, Arizona, California, Colorado, Florida, Illinois, Indiana, Massachusetts, Minnesota, Missouri, North Carolina, New York, Ohio, Pennsylvania, South Carolina, Tennessee, Texas, and Virginia.
What to do
We don't have product-specific instructions for this recall. FDA's general advice for medical device recalls:
- A device recall doesn't always mean you must stop using it: it may need to be checked, adjusted or fixed.
- Talk to your health care provider before you stop using it.
Is yours affected?
2 products
Compare the details below with your product and check the FDA notice to confirm whether it is affected.
PIE Trolley System
- Model
- 2005
- Lot code
- All Lots
PIE Pak Models: P2HC-A, P2HC-S, P2HC
- Lot code
- All Lots UDI:
Recall details
- Company began the recall
- Sold in
US Nationwide distribution in the states of Ohio, Arizona, Illinois, Pennsylvania, Indiana, California, Missouri, Massachusetts, Minnesota, Virginia, Florida, New York, Alabama, South Carolina, North Carolina, Tennessee, Texas, Colorado.
- Company
- Edermy LLCPendergrass, Georgia
- Hazard
- Unapproved product
- Risk
Moderate risk
Using it may cause short-term health problems, or ones that treatment can reverse. Serious harm is unlikely.
FDA Class II recall · How risk is rated
- Event ID
- 98303
- Recall numbers
- Z-1461-2026 to Z-1462-2026
Timeline
FDA's Enforcement Report is its public list of recalls; FDA adds a recall when it posts it and publishes the list weekly.
Company began the recall
Added to FDA's Enforcement Report · Classified by FDA
In FDA's weekly enforcement report
Listed on Recall Canary
Summary updated
