Saint Paul, MN, United States
SurgiSmoke Solutions recalls
1 recall recorded since 2018, most recently on 16 March 2026. 1 is listed as ongoing. Status and classification are as published by the FDA.
Recalls1
Ongoing (FDA)1
Terminated or completed0
Class I (FDA)0
Ongoing Class II Medical devices
- Recall started
- 16 March 2026
- Reason
- Certain lots of product were associated with a manufacturing nonconformance involving use of a non-gamma sterilization compatible drape.
- 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.
- Initiated
- Voluntary: Firm initiated
- Recall numbers
- Z-1924-2026, Z-1925-2026, Z-1926-2026
- Flamingo Funnel Small, Model Number SQ20012-01
- Flamingo Funnel Medium, Model Number SQ20012-02
- Flamingo Funnel Large, Model Number SQ20012-03
A terminated FDA recall means the FDA has determined that all reasonable efforts to remove or correct the product have been made. What statuses mean.