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Open, Classified

One-piece Guedel airway, size 3, ISO 9.0, yellow. Model Number: 1113090.

FDA Recall Z-2276-2025 · Posted 2025-08-06

Recalling FirmIntersurgical Inc
Recall StatusOpen, Classified
Product CodeCAE
Date Initiated2025-06-20
Product Quantity8,640 pieces

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.

Firm 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.

Root Cause

Process control

Distribution Pattern

US distribution to AZ, CA, CT, FL, FL, HI, MA, MI, OH, UT, VA.

Official Source

View FDA Recall →

Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.

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