Flamingo Funnel Medium — Class II medical device recall Z-1925-2026
Ongoing recall by SurgiSmoke Solutions, reported 2026-04-29, distributed nationwide. Certain lots of product were associated with a manufacturing nonconformance involving use of a non-gamma steri
| Recall number | Z-1925-2026 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Ongoing |
| Voluntary or mandated | Voluntary |
| Recalling firm | SurgiSmoke Solutions, Saint Paul, MN, United States |
| Recall initiated | 2026-03-16 |
| Classified | 2026-04-22 |
| Reported by FDA | 2026-04-29 |
| Distributed | Nationwide (US) |
| Countries outside the US | CA |
| Quantity | 2,505 units |
| UPC / GTIN / UDI-DI | 00860012888818 |
| Lot numbers | 8264601 |
| Model numbers | SQ20012-02 |
Product
Flamingo Funnel Medium, Model Number SQ20012-02
Reason for recall
Certain lots of product were associated with a manufacturing nonconformance involving use of a non-gamma sterilization compatible drape.
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/Z-1925-2026. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.