FDA DevicesClass II
Flamingo Funnel Large, Model Number SQ20012-03
Published: April 29, 2026Recall ID: Z-1926-2026Category: devicesCountry: US
Reason for Recall / Hazard
Certain lots of product were associated with a manufacturing nonconformance involving use of a non-gamma sterilization compatible drape.
Product Description & Identification
Flamingo Funnel Large, Model Number SQ20012-03
Additional Source Details
| Field | Value |
|---|---|
| City | Saint Paul |
| State | MN |
| Event id | 98574 |
| Address 1 | 2300 Myrtle Ave Ste 200 |
| Address 2 | N/A |
| Code info | UDI-DI: 408882777851966; Lot 8264501 |
| Postal code | 55114-1948 |
| Report date | 20260429 |
| Product type | Devices |
| Product quantity | 2505 units total |
| Reason for recall | Certain lots of product were associated with a manufacturing nonconformance involving use of a non-gamma sterilization compatible drape. |
| Voluntary mandated | Voluntary: Firm initiated |
| Recall initiation date | 20260316 |
| Initial firm notification | Letter |
| Center classification date | 20260422 |
Overview
- Recalling FirmSurgiSmoke Solutions
- StatusOngoing
- Risk LevelClass II
- DistributionWorldwide - 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.