FDA DeviceClass IINotable

FDA Recall: Flamingo Funnel Large, Model Number SQ20012-03

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

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