Intersurgical Inc recalls One-Piece Guedel Airway
Devices could potentially be occluded or partially occluded.
- Anesthesiology Oropharyngeal Airway
- Process control
The FDA has posted 5 enforcement recalls of anesthesiology oropharyngeal airway devices since 2025, none of them Class I (most serious). Most recent report: Aug 26, 2026.
Devices could potentially be occluded or partially occluded.
Devices could potentially be occluded or partially occluded.
Devices could potentially contain an occluded or partially occluded Guedel Airway tip.
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.
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.
Source: U.S. FDA openFDA device enforcement reports, updated continuously. Device type per the FDA's RES classification (“Airway, Oropharyngeal, Anesthesiology”). Informational only — verify against the FDA before acting.