One-piece Guedel airway, size 2, ISO 8.0, green. Model Number: 1112080.
FDA Recall #Z-2275-2025 — Class II — June 20, 2025
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.
Recalling Firm
Intersurgical Inc — East Syracuse, NY
Classification
Class II — May cause temporary or medically reversible adverse health consequences.
Product Type
Devices
Product Quantity
2,800 pieces
Distribution
US distribution to AZ, CA, CT, FL, FL, HI, MA, MI, OH, UT, VA.
Code Information
Model Number: 1112080. UDI-DI (Case): 05030267040698, UDI-DI (Single Unit): 5030267050659. Lot Number: 32414447
Status
Ongoing
Voluntary / Mandated
Voluntary: Firm initiated