FDA Device recall Z-1925-2026
Flamingo Funnel Medium, Model Number SQ20012-02
- FDA Device
- Class II
- ongoing
- Published 2026-04-29
On 2026-04-29 the FDA classified a Class II recall of Flamingo Funnel Medium, Model Number SQ20012-02 by Surgismoke Solutions, citing certain lots of product were associated with a manufacturing nonconformance involving use of a non-gamma sterilization compatible drape.
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-1925-2026 |
| Classification | Class II |
| Status | ongoing |
| Initiated | 2026-03-16 |
| Published | 2026-04-29 |
| Last updated | 2026-09-13 11:58 UTC |
| Company | Surgismoke Solutions |
| Distribution | US |
Product
Flamingo Funnel Medium, Model Number SQ20012-02
Reason
Certain lots of product were associated with a manufacturing nonconformance involving use of a non-gamma sterilization compatible drape.
Identifiers
| code_info | UDI-DI: 0860012888818; Lot 8264601 |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:58 UTC. Current status: ongoing.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-1925-2026%22
RecallRadar indexes public recall notices from the FDA, USDA FSIS, and CPSC. The official agency notice is the authoritative source. Always confirm details at the linked source before acting.