FDA Recall
Open, Classified
One-piece Guedel airway, size 3, ISO 9.0, yellow. Model Number: 1113090.
Recall: Z-2276-2025
·
Initiated June 20, 2025
Recall
- Recall Number
- Z-2276-2025
- Event Number
- 97127
- Firm
- Intersurgical Inc
- FEI Number
- 1000120301
- Product Code
- CAE
- Status
- Open, Classified
- Root Cause
- Process control
- Initiated
- June 20, 2025
- Posted
- August 6, 2025
- Address
- 5010 Campuswood Dr, Ste 102, East Syracuse, NY, 13057-1561
Description
One-piece Guedel airway, size 3, ISO 9.0, yellow. Model Number: 1113090.
Reason
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
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.
Distribution
US distribution to AZ, CA, CT, FL, FL, HI, MA, MI, OH, UT, VA.
Quantity
8,640 pieces