Intersurgical Inc recalls One-piece Guedel airway

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.

Intersurgical notified consignees on 06/20/2025 via email with recall letter. Consignees were instructed to immediately discontinue use and quarantine any affected units, immediately notify customers if product has been further distributed, arrange for the return of affected units and complete the Customer Product Recall Acknowledgement Form.

• FDA enforcement recordOfficial FDA database entry for Z-2276-2025
• FDA device classification · CAEOfficial FDA classification for this device type
• CFR regulation · 21 CFR 868.5110The federal regulation governing this device
• FDA recall announcementSearch FDA.gov for the official press announcement
• Find Intersurgical IncSearch for the manufacturer's official notice
• News coverageRecent reporting on this recall and manufacturer
• openFDA data recordThe raw JSON record this page is built from

Source: U.S. FDA openFDA device enforcement reports. This summary is informational and may lag or differ from the official record. Always verify against the FDA before acting.