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Recall Observatory FDA recall evidence

Device product

Flamingo Funnel Large, Model Number SQ20012-03

Z-1926-2026

March 16, 2026

Class II

Product summary

Firm
SurgiSmoke Solutions
Event
Event 98574
Status
Ongoing
Classification
Class II
Quantity
2505 units total
Official record key
device-enforcement:Z-1926-2026

Official wording

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

Code information: UDI-DI: 408882777851966; Lot 8264501

Distribution pattern: 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.

Derived failure modes

  • Manufacturing or process control

    reason.manufacturing_process_control · v1.0.0

    manufacturing nonconformance