Class II

Medical Device Recall: One-piece Guedel airway, size 2, ISO 8.0, green. Model Number: 1112080.

Intersurgical Inc · June 20, 2025

Reason for Recall

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.

Distribution

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

States Affected

AZ, CA, CT, FL, HI, MA, MI, OH, UT, VA

Quantity Affected

2,800 pieces

Source: FDA (openFDA Device Enforcement)

Recall number: Z-2275-2025

Status: ongoing

SafeCheck provides drug interaction information from FDA-approved product labeling (openFDA). This is for informational purposes only and is not medical advice. Always consult your healthcare provider before making medication decisions.

Intersurgical Inc Medical Device Recall: One-piece Guedel airway, size 2, ISO 8.0, green. Model Number: 1112080. | SafeCheck