Intersurgical Inc recalls One-Piece Guedel Airway

Devices could potentially be occluded or partially occluded.

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

An URGENT MEDICAL DEVICE RECALL notification dated 6/12/26 was mailed and to consignees. The notification instructs consignees to immediately discontinue use of affected devices and quarantine any stock remaining. If product has been further distributed a copy of the recall notification is to be forwarded and collect their affected product. To coordinate return of goods contact Intersurgical Customer Support at 800-828-9633 from Monday through Thursday, 8:00 AM to 3:00 PM EST, and follow the provided instructions.

• FDA enforcement recordOfficial FDA database entry for Z-2953-2026
• 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.