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Intersurgical Inc recalls One-piece Guedel airway, size 3, ISO 9.0, yellow. Model Number: 1113090.
Recalled August 13, 2025 · FDA recall Z-2276-2025 · Intersurgical
Hazard
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. · FDA Class II
Units
8,640 pieces
Sold at
US distribution to AZ, CA, CT, FL, FL, HI, MA, MI, OH, UT, VA.
Description
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.
Product
One-piece Guedel airway, size 3, ISO 9.0, yellow. Model Number: 1113090.
Manufacturer(s)
Intersurgical Inc
Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →