Z-1926-2026 Class II Ongoing

Recalled by SurgiSmoke Solutions — Saint Paul, MN

Recall Details

Product Type
Devices
Report Date
April 29, 2026
Initiation Date
March 16, 2026
Termination Date
N/A
Voluntary/Mandated
Voluntary: Firm initiated
Product Quantity
2505 units total

Product Description

Flamingo Funnel Large, Model Number SQ20012-03

Reason for Recall

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

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.

Code Information

UDI-DI: 408882777851966; Lot 8264501