Class 2 Device Recall Onepiece Guedel airway

• Date Initiated by Firm: June 20, 2025
• Date Posted: August 06, 2025
• Recall Status: Open, Classified
• Recall Number: Z-2275-2025
• Recall Event ID: 97127
• Product Classification: Airway, oropharyngeal, anesthesiology - Product Code CAE
• Product: One-piece Guedel airway, size 2, ISO 8.0, green. Model Number: 1112080.
• Code Information: Model Number: 1112080. UDI-DI (Case): 05030267040698, UDI-DI (Single Unit): 5030267050659. Lot Number: 32414447
• Recalling Firm/ Manufacturer: Intersurgical Inc; 5010 Campuswood Dr Ste 102; East Syracuse NY 13057-1561
• For Additional Information Contact: 315-451-2900
• Manufacturer 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.
• FDA Determined Cause: Process control
• Action: Intersurgical notified consignees on 06/20/2025 via email with recall letter. Consignees were instructed to immediately discontinue use and quarantine any affected units, immediately notify customers if product has been further distributed, arrange for the return of affected units and complete the Customer Product Recall Acknowledgement Form.
• Quantity in Commerce: 2,800 pieces
• Distribution: US distribution to AZ, CA, CT, FL, FL, HI, MA, MI, OH, UT, VA.
• Total Product Life Cycle: TPLC Device Report

¹ A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
² Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
³ The manufacturer has initiated the recall and not all products have been corrected or removed. This record will be updated as the status changes.