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SurgiSmoke Solutions: Flamingo Funnel Large, Model Number SQ20012-03

Medical DevicesSource: FDA (device) · Date: 2026-04-29

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The text below is copied from the official FDA (device) record. If anything differs, the official notice is correct.

Company / brand
SurgiSmoke Solutions
Product
Flamingo Funnel Large, Model Number SQ20012-03
Reason / hazard
Certain lots of product were associated with a manufacturing nonconformance involving use of a non-gamma sterilization compatible drape.
Classification
Class II
Status
Ongoing
Distribution / sold at
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.
Recall initiated
2026-03-16
Code info
UDI-DI: 408882777851966; Lot 8264501
Product quantity
2505 units total
Voluntary mandated
Voluntary: Firm initiated
City
Saint Paul
State
MN
Country
United States
Event id
98574
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