One-piece Guedel airway, size 3, ISO 9.0, yellow. Model Number: 1113090.
FDA device recall Z-2276-2025 · posted 2025-08-06 · Open, Classified
Recall details
- Recalling firm
- Intersurgical Inc
- 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.
- 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.
- Root cause
- Process control
- Status
- Open, Classified
- Product code
- CAE
- Quantity affected
- 8,640 pieces
- Distribution
- US distribution to AZ, CA, CT, FL, FL, HI, MA, MI, OH, UT, VA.
- Date initiated
- 2025-06-20
- Date posted
- 2025-08-06
- Location
- East Syracuse, NY
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