PIE PAK Models: P2HC-A recall (Edermy LLC)
Medical deviceClass IIOngoing
Summary: Edermy LLC is recalling PIE PAK Models: P2HC-A, P2HC-S, P2HC. Reason: Lack of 510K clearance.
What is being recalled
PIE PAK Models: P2HC-A, P2HC-S, P2HC
Why
Lack of 510K clearance
How serious is it
Class II is the middle level: using or being exposed to this product may cause temporary or medically reversible health problems, and the chance of serious harm is remote.
Where it was sold
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. (states named: Alabama, Arizona, California, Colorado, Florida, Illinois, Indiana, Massachusetts, Minnesota, Missouri, North Carolina, New York, Ohio, Pennsylvania, South Carolina, Tennessee, Texas, Virginia)
How to tell if yours is affected
All Lots UDI:
What to do
Check the model, lot or serial numbers above against your device. If yours is affected, contact the manufacturer or your healthcare provider before you stop using a device you rely on.
Recall facts
| Recall number | Z-1462-2026 |
| Category | Medical device |
| Agency | U.S. Food and Drug Administration (FDA) |
| Severity | Class II |
| Status | Ongoing |
| Recall started | January 14, 2026 |
| Reported | March 4, 2026 |
| Company | Edermy LLC |
| Company location | Pendergrass, GA, United States |
| Initiated by | Voluntary: Firm initiated |
| Quantity | 11202 units |
More recalls from Edermy LLC · all medical device recalls · recalls from January 2026