← FDA ENFORCEMENT
Z-1926-2026Class II

SurgiSmoke Solutions

What this record is not

A recall record is reproduced as FDA published it, and the classification is FDA’s. SPEQ adds no interpretation, and a recall concerns the products and dates in the record — it is not a statement about a company’s other products or its current status.

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 Monitoring
Reason 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. 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. Open the enforcement explorer →