Intersurgical Inc: Airway, Oropharyngeal, Anesthesiology

Recalling firm
Intersurgical Inc
Product
One-Piece Guedel Airway, size 000, ISO 3.5, Light Green. Oropharyngeal Airway Device.
Reason
Devices could potentially be occluded or partially occluded.
Classification
Class I
Category
medical device recall
Country
United States
Agency
FDA-DEVICES
Recall date
2026-06-15
Status
Open, Classified
Areas affected
AL, AK, AZ, AR, CA, CO, CT, DE, FL, GA, HI, ID, ...
Distribution
US Nationwide distribution in the states of CT, FL, IN, MI, OH & VA.

Official recall notice from FDA-DEVICES

Recall details on Nibble Recalls: https://trynibble.app/recalls/78d9d224-026d-4098-872d-154fe66aedc6