Recall Z-2275-2025 ยท CAE Airway, Oropharyngeal, Anesthesiology
Intersurgical Inc
One-piece Guedel airway, size 2, ISO 8.0, green. Model Number: 1112080.
| Date | Aug 6, 2025 (initiated Jun 20, 2025) |
| Status | Open, Classified |
| 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. |
| Root cause | Process control |
| 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. |
| Quantity | 2,800 pieces |
| Distribution | US distribution to AZ, CA, CT, FL, FL, HI, MA, MI, OH, UT, VA. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
This recall record lists no 510(k) number.