FDAHealthMarch 16, 2026
SurgiSmoke Solutions — Flamingo Funnel Large, Model Number SQ20012-03
⚠️ Certain lots of product were associated with a manufacturing nonconformance involving use of a non-gamma sterilization compatible drape.
Is this relevant to me?
- Geography
- Nationwide
- Source agency
- FDA
- Category
- Health
- Published
- March 16, 2026
Worldwide - US Nationwide distribution in the states of CA, CO, GA, MA, MD, ME, MN, NH, NY, OH, TN, TX, and UT. The country of Canada.
What's affected?
- Product
- Flamingo Funnel Large, Model Number SQ20012-03
- Brand
- SurgiSmoke Solutions
- Lot code
- 8264501
Additional details
UDI-DI: 408882777851966; Lot 8264501
What should I do?
Recommended action
Class II recall. Voluntary: Firm initiated Quantity affected: 2505 units total.
Get Health recall alerts
Delivered to your inbox. Free. No account required.