One-piece Guedel airway, size 3, ISO 9.0, yellow. Model Number: 1113090.
This recall is currently active, issued August 6, 2025. It was issued by Intersurgical Inc.
- Company
- Intersurgical Inc
- Recall Initiated
- June 20, 2025
- Posted
- August 6, 2025
- Recall Number
- Z-2276-2025
- Quantity
- 8,640 pieces
- Firm Location
- East Syracuse, NY
- Official Source
- View on FDA website ↗
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.
Distribution
US distribution to AZ, CA, CT, FL, FL, HI, MA, MI, OH, UT, VA.
Lot / Code Info
Model Number: 1113090. UDI-DI (Case): 05030267153961, UDI-DI (Single Unit): 5030267050680. Lot Number: 32420657
Root Cause
Process control
Action Taken
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.