Warning
SurgiSmoke Solutions Recalls Flamingo Funnel Medium, Model Number SQ20012-02
This is a Class II recall. This product may cause temporary health problems or pose a slight threat of a serious nature.
Source: FDA
WarningRecall #Z-1925-2026Medical Device
SurgiSmoke Solutions Recalls Flamingo Funnel Medium, Model Number SQ20012-02
SurgiSmoke Solutions · Class II — Moderate Risk
Product Description
Flamingo Funnel Medium, Model Number SQ20012-02
Reason for Recall
Certain lots of product were associated with a manufacturing nonconformance involving use of a non-gamma sterilization compatible drape.
FDA Classification
Class II — Moderate Risk
A situation in which use of, or exposure to, a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
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.
Remedy
Consumers should stop using this product. Contact the recalling firm for further instructions regarding this product.
411 Press Analysis
The FDA classified this recall as Class II, indicating the medical device may cause temporary health problems or poses a slight threat of a serious nature. SurgiSmoke Solutions initiated the recall on March 16, 2026 affecting 2505 units total. Certain lots of product were associated with a manufacturing nonconformance involving use of a non-gamma sterilization compatible drape. The product was distributed internationally, including the United States. Consumers should check their purchases and discontinue use of any affected product. Contact SurgiSmoke Solutions for further instructions.
Sources: FDA openFDA Enforcement Database
This recall appears in: Medical Device Defects.