Recalling firm
SurgiSmoke Solutions
Product type
Device
Status
Ongoing
Report date
2026-04-29
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.
Firm state
MN
Product quantity
2505 units total
Initiated by
Voluntary: Firm initiated
SPEQ quality domain
Environmental MonitoringReason for recall
Certain lots of product were associated with a manufacturing nonconformance involving use of a non-gamma sterilization compatible drape.
Product description
Flamingo Funnel Large, Model Number SQ20012-03
Code / lot info
UDI-DI: 408882777851966; Lot 8264501
Other recalls SPEQ maps to Environmental Monitoring
See all Environmental Monitoring recalls →Data: U.S. FDA openFDA enforcement API. Recall details are as reported by the FDA. The quality-domain mapping and severity are a SPEQ editorial interpretation of the recall reason, not an official FDA classification.