FDA DeviceClass IINotable

FDA Recall: Flamingo Funnel Small, Model Number SQ20012-01

Name: FDA Recall: Flamingo Funnel Small, Model Number SQ20012-01
Brand: SurgiSmoke Solutions

Date: 2026-04-29

FDA Class: Class II

Description

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

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

2505 units total