Official recall notice
FDA DeviceClass IINotable
FDA Recall: PIE Trolley System Model: 2005
- Recall date
- 2026-03-04
- Brand
- Edermy LLC
- Category
- Medical Device
- FDA class
- Class II
Why it was recalled
Hazard
Lack of 510K clearance
Recommended action
What to do
27 units
Product description
Lack of 510K clearance