Recall Z-2275-2025— Intersurgical Inc

Name: FDA recall Z-2275-2025
Creator: U.S. Food and Drug Administration
Published: 2025-06-20

Class II · Ongoing

Class II FDA medical device recall by Intersurgical Inc, initiated 2025-06-20. FDA's recall record names no specific 510(k) clearance for this event. Product: One-piece Guedel airway, size 2, ISO 8.0, green. Model Number: 1112080.. Reason: 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..

Recalling firm: Intersurgical Inc
Classification: Class II
Status: Ongoing
Initiated: 2025-06-20
Firm location: East Syracuse, NY, United States

Product description

One-piece Guedel airway, size 2, ISO 8.0, green. Model Number: 1112080.

Reason for recall

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.

Data sourced from openFDA. This site is unofficial and independent of the FDA.