Guedel Airway Size 3 (Intersurgical) – Contamination Risk (2025)
Small detachable burrs in an airway device can potentially cause airway obstruction or tissue irritation.
This AI-generated summary is provided for general informational purposes only and is derived from publicly available recall notices. It supplements but does not replace official agency classifications or safety instructions.
Check Your Product
According to the U.S. Food and Drug Administration (FDA)
Product
One-piece Guedel airway, size 3, ISO 9.0, yellow. Model Number: 1113090.
Brand
Intersurgical Inc
Lot Codes / Batch Numbers
Model Number: 1113090. UDI-DI (Case): 05030267153961, UDI-DI (Single Unit): 5030267050680. Lot Number: 32420657
Products Sold
Model Number: 1113090. UDI-DI (Case): 05030267153961, UDI-DI (Single Unit): 5030267050680. Lot Number: 32420657
Intersurgical Inc is recalling One-piece Guedel airway, size 3, ISO 9.0, yellow. Model Number: 1113090. due to Potential contamination with small burrs, which if detach could be inhaled and result in potential complications such as airway obstruction, tissue ir. Based on FDA medical device recall database.
Summary derived from FDA notice
Reason for Recall
As stated by FDA
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.
Recommended Action
Per FDA guidance
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.
Verify this information on the official source
For complete details and official instructions, check the U.S. Food and Drug Administration (FDA) directly.
View official FDA recall noticeDistribution
As reported by FDA
AZ, CA, CT, FL, HI, MA, MI, OH, UT, VA
Page updated: Jan 10, 2026