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MEDICAL DEVICE RECALLMODERATE
PIE PAK Trolley System
Edermy is recalling PIE PAK trolley systems (models P2HC-A, P2HC-S, P2HC) due to a lack of required 510(k) clearance.
What to do
Stop using the affected PIE PAK trolley systems immediately and contact Edermy LLC for further instructions.
Why it was recalled
Edermy LLC is recalling PIE PAK trolley systems because the products lack the required 510(k) clearance for medical devices. The affected models are P2HC-A, P2HC-S, and P2HC.
Is mine affected?
Check the model, lot, or serial number on the device or its packaging. Yours is affected if it matches one below.
PIE Trolley System
- Model
- 2005
Where it was sold
Distributed nationwide.
Timeline
- Firm initiated recall
- Publicly announced
- Listed on Recall Canary
- Summary updated
Official source
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Editorial summary by Recall Canary · summary updated 2026-07-11 · primary source: U.S. Food and Drug Administration · severity reflects the agency's published classification