FDA DeviceClass IINotable

FDA Recall: Flamingo Funnel Medium, Model Number SQ20012-02

Date: 2026-04-29
Brand: SurgiSmoke Solutions
Category: Medical Device
FDA Class: Class II

Description

Certain lots of product were associated with a manufacturing nonconformance involving use of a non-gamma sterilization compatible drape.

Hazard

Certain lots of product were associated with a manufacturing nonconformance involving use of a non-gamma sterilization compatible drape.

Remedy

2505 units total

View original recall →
Share:

Related Recalls

2026-04-29 · FDA_DEVICE
FDA Recall: Flamingo Funnel Large, Model Number SQ20012-03
SurgiSmoke Solutions
2026-04-29 · FDA_DEVICE
FDA Recall: Flamingo Funnel Small, Model Number SQ20012-01
SurgiSmoke Solutions