Funnel Recall: SurgiSmoke Solutions Flamingo Large SQ20012-03
Announced 2026-04-29 · FDA
The Flamingo Funnel Large, model SQ20012-03, is recalled due to a manufacturing nonconformance involving a non-gamma sterilization compatible drape. About 2,505 units have been distributed worldwide, including the US (CA, CO, GA, MA, MD, ME, MN, NH, NY, OH, TN, TX, UT) and Canada; the FDA is the recalling agency. Recall numbers are UDI-DI: 408882777851966 and Lot 8264501.
| Brand | SurgiSmoke Solutions |
|---|---|
| Product | Flamingo Funnel Large, Model Number SQ20012-03 |
| Reason | Certain lots of product were associated with a manufacturing nonconformance involving use of a non-gamma sterilization compatible drape. |
| Severity | moderate |
| Units affected | 2505 |
| 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. |
| Agency | FDA |
| Recall / campaign no. | UDI-DI: 408882777851966; Lot 8264501 |
WHAT YOU SHOULD DO
- Stop using the product immediately.
- Check if your unit is SQ20012-03 with Lot 8264501 or UDI-DI 408882777851966.
- Contact SurgiSmoke Solutions for return, replacement, or refund instructions.
- Follow any additional guidance from the FDA.
This is an automatically maintained record of an official recall notice. Details can change; always follow the official notice linked above. See all records in the Recall Database.