Class II

Medical Device Recall: One-Piece Guedel Airway, size 000, ISO 3.5, Light Green. Oropharyngeal Airway Device.

Intersurgical Inc · June 15, 2026

Reason for Recall

Devices could potentially be occluded or partially occluded.

Distribution

US Nationwide distribution in the states of CT, FL, IN, MI, OH & VA.

States Affected

NATIONWIDE

Quantity Affected

1,575 units

Source: FDA (openFDA Device Enforcement)

Recall number: Z-2953-2026

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 000, ISO 3.5, Light Green. Oropharyngeal Airway Device. | SafeCheck