One-piece Guedel airway — Class II medical device recall Z-2276-2025
Ongoing recall by Intersurgical Inc, reported 2025-08-13, distributed in AZ, CA, CT, FL, HI, MA, MI, OH…. Potential contamination with small burrs, which if detach could be inhaled and result in potential complicatio
| Recall number | Z-2276-2025 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Ongoing |
| Voluntary or mandated | Voluntary |
| Recalling firm | Intersurgical Inc, East Syracuse, NY, United States |
| Recall initiated | 2025-06-20 |
| Classified | 2025-08-06 |
| Reported by FDA | 2025-08-13 |
| Distributed | AZ, CA, CT, FL, HI, MA, MI, OH, UT, VA |
| Quantity | 8,640 units |
| Reason classes | device malfunction |
| UPC / GTIN / UDI-DI | 05030267050680, 05030267153961 |
| Lot numbers | 32420657 |
| Model numbers | 1113090 |
Product
One-piece Guedel airway, size 3, ISO 9.0, yellow. Model Number: 1113090.
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.
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/Z-2276-2025. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.