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 from Intersurgical Inc since 2025, including 1 Class I (most serious) recall. Most recent report: Aug 26, 2026.
Devices could potentially be occluded or partially occluded.
Devices could potentially be occluded or partially occluded.
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.
Potential for faulty devices as a result of depleted batteries.
Firm name as filed with the FDA: “Intersurgical Inc”. Related firm entities may file under separate names. Source: U.S. FDA openFDA device enforcement reports. Informational only — verify with the FDA before acting.