SurgiSmoke Solutions FDA Recalls

3 recalls on file across devices, 0 of them Class I and 3 still open. This firm is not matched to a listed company.

Newest first

Class I is the FDA's most serious grade: a reasonable probability of serious harm or death.

Product	Reason	Class	Initiated
Flamingo Funnel Small, Model Number SQ20012-01Class IIMar 16, 2026Certain lots of product were associated with a manufacturing	Certain lots of product were associated with a manufacturing nonconformance involving use of a non-gamma steri	Class IIDevices	Mar 16, 2026
Flamingo Funnel Large, Model Number SQ20012-03Class IIMar 16, 2026Certain lots of product were associated with a manufacturing	Certain lots of product were associated with a manufacturing nonconformance involving use of a non-gamma steri	Class IIDevices	Mar 16, 2026
Flamingo Funnel Medium, Model Number SQ20012-02Class IIMar 16, 2026Certain lots of product were associated with a manufacturing	Certain lots of product were associated with a manufacturing nonconformance involving use of a non-gamma steri	Class IIDevices	Mar 16, 2026