Official recall notice
FDA DeviceClass IINotable
FDA Recall: Flamingo Funnel Large, Model Number SQ20012-03
- Recall date
- 2026-04-29
- Brand
- SurgiSmoke Solutions
- Category
- Medical Device
- FDA class
- Class II
Why it was recalled
Hazard
Certain lots of product were associated with a manufacturing nonconformance involving use of a non-gamma sterilization compatible drape.
Recommended action
What to do
2505 units total
Product description
Certain lots of product were associated with a manufacturing nonconformance involving use of a non-gamma sterilization compatible drape.