FDAHealthMarch 16, 2026
SurgiSmoke Solutions — Flamingo Funnel Small, Model Number SQ20012-01
⚠️ 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 Small, Model Number SQ20012-01
- Brand
- SurgiSmoke Solutions
- Lot code
- 8264701
Additional details
UDI-DI: 0860012888801; Lot 8264701
What should I do?
Recommended action
Class II recall. Voluntary: Firm initiated Quantity affected: 2505 units total.
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