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CLASS II · ModerateFDA

SurgiSmoke Solutions recalls Flamingo Funnel Small

📅 Mar 16, 2026 · 📍 Nationwide
Recalling company
SurgiSmoke Solutions
Product
Flamingo Funnel Small, Model Number SQ20012-01
Reason
Certain lots of product were associated with a manufacturing nonconformance involving use of a non-gamma sterilization compatible drape.
Classification
Class II – may cause temporary or medically reversible health consequences
Recall date
Mar 16, 2026
Reported
Apr 29, 2026
Distribution
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.
Status
Ongoing
Quantity
2505 units total
Lot / codes
UDI-DI: 0860012888801; Lot 8264701
Company location
Saint Paul, MN
Recall type
Voluntary: Firm initiated
Recall number
Z-1924-2026
Agency
U.S. Food and Drug Administration (FDA)

View official FDA notice ↗ Search recall number Z-1924-2026 in the FDA Enforcement Report. Also see FDA recall press releases.

If you use this product, check the lot, NDC or model number against the official notice and follow its instructions. Do not stop a prescribed medicine or remove a medical device without talking to your doctor or pharmacist. Report problems to FDA MedWatch. FoodRecallNow summarizes public FDA data and is not medical advice.