FDA recall, , Moderate risk
SurgiSmoke Solutions Flamingo Funnel
Flamingo Funnels were made with a non-gamma sterilization compatible drape.
Summary by Recall Canary from the FDA notice
What happened
SurgiSmoke Solutions of Saint Paul, Minnesota recalled Flamingo Funnel Small, Medium, and Large models SQ20012-01, SQ20012-02, and SQ20012-03 because certain lots were associated with a manufacturing nonconformance involving use of a non-gamma sterilization compatible drape. The recall began March 16, 2026, and was added to the FDA's Enforcement Report on April 22, 2026.
Distribution included US Nationwide distribution in the states of CA, CO, GA, MA, MD, ME, MN, NH, NY, OH, TN, TX, and UT, and the country of Canada.
What to do
We don't have product-specific instructions for this recall. FDA's general advice for medical device recalls:
- A device recall doesn't always mean you must stop using it: it may need to be checked, adjusted or fixed.
- Talk to your health care provider before you stop using it.
Is yours affected?
3 products
Match the UDI-DI and lot code listed under your product.
A UDI-DI is the device identifier printed with the barcode on the device label.
Flamingo Funnel Small, Model Number SQ20012-01
- UDI-DI
- 0860012888801
- Lot code
- 8264701
Flamingo Funnel Medium, Model Number SQ20012-02
- UDI-DI
- 0860012888818
- Lot code
- 8264601
Flamingo Funnel Large, Model Number SQ20012-03
- Lot code
- 8264501
Recall details
- Company began the recall
- Sold in
Worldwide - US Nationwide distribution in the states of California, Colorado, Georgia, Massachusetts, Maryland, Maine, Minnesota, New Hampshire, New York, Ohio, Tennessee, Texas, and Utah. The country of Canada.
- Company
- SurgiSmoke SolutionsSaint Paul, Minnesota
- Hazard
- Manufacturing problem
- Risk
Moderate risk
Using it may cause short-term health problems, or ones that treatment can reverse. Serious harm is unlikely.
FDA Class II recall · How risk is rated
- Event ID
- 98574
- Recall numbers
- Z-1924-2026 to Z-1926-2026
Timeline
FDA's Enforcement Report is its public list of recalls; FDA adds a recall when it posts it and publishes the list weekly.
Company began the recall
Added to FDA's Enforcement Report · Classified by FDA
Listed on Recall Canary
In FDA's weekly enforcement report
Summary updated
