Intersurgical Inc recalls One-piece Guedel airway, size 3, ISO 9.0, yellow. Model Number: 1113090.

Recall date

June 20, 2025

Source

U.S. Food & Drug Administration (FDA) — enforcement report

Recall number

Z-2276-2025

FDA classification

Class II

Brand / firm

Intersurgical Inc

Sold / distributed

US distribution to AZ, CA, CT, FL, FL, HI, MA, MI, OH, UT, VA.

Why it was recalled

Potential contamination with small burrs, which if detach could be inhaled and result in potential complications such as airway obstruction, tissue irritation, inflammation and infection.

Class II means using this product may cause temporary or medically reversible health problems; the chance of serious harm is remote.

What was recalled

One-piece Guedel airway, size 3, ISO 9.0, yellow. Model Number: 1113090.