Flamingo Funnel Small recall (SurgiSmoke Solutions)
Medical deviceClass IIOngoing
Summary: SurgiSmoke Solutions is recalling 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.
What is being recalled
Flamingo Funnel Small, Model Number SQ20012-01
Why
Certain lots of product were associated with a manufacturing nonconformance involving use of a non-gamma sterilization compatible drape.
How serious is it
Class II is the middle level: using or being exposed to this product may cause temporary or medically reversible health problems, and the chance of serious harm is remote.
Where it was sold
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. (states named: California, Colorado, Georgia, Massachusetts, Maryland, Maine, Minnesota, New Hampshire, New York, Ohio, Tennessee, Texas, Utah)
How to tell if yours is affected
UDI-DI: 0860012888801; Lot 8264701
What to do
Check the model, lot or serial numbers above against your device. If yours is affected, contact the manufacturer or your healthcare provider before you stop using a device you rely on.
Recall facts
| Recall number | Z-1924-2026 |
| Category | Medical device |
| Agency | U.S. Food and Drug Administration (FDA) |
| Severity | Class II |
| Status | Ongoing |
| Recall started | March 16, 2026 |
| Reported | April 29, 2026 |
| Company | SurgiSmoke Solutions |
| Company location | Saint Paul, MN, United States |
| Initiated by | Voluntary: Firm initiated |
| Quantity | 2505 units total |
More recalls from SurgiSmoke Solutions · all medical device recalls · recalls from March 2026