HIGH

Flamingo Funnel Large, Model Number SQ20012-03

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

Quick Facts at a Glance

Recall Date
March 16, 2026
Hazard Level
HIGH
Brand
SurgiSmoke Solutions
Geographic Scope
1 states

Hazard Information

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

What You Should Do

Patients and healthcare providers should stop using this device immediately. Follow the recall instructions provided by the manufacturer. Contact SurgiSmoke Solutions or your healthcare provider for instructions. Notification method: Letter

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Full Description

Flamingo Funnel Large, Model Number SQ20012-03. Reason: Certain lots of product were associated with a manufacturing nonconformance involving use of a non-gamma sterilization compatible drape.. Classification: Class II. Quantity: 2505 units total. Distribution: Worldwide - US Nationwide distribution in the states of CA, CO, GA, MA, MD, ME, MN, NH, NY, OH, TN, TX, and UT. The country of Canada.

Safety Guide

Not sure what to do next? Our guide walks you through the process step by step.

Read: How to Get Refunds and Replacements

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Product Classification

Product Details

Model Numbers
UDI-DI: 408882777851966
Lot 8264501
Affected States
ALL
Report Date
April 29, 2026
Recall Status
ACTIVE