One-Piece Guedel Airway — Class II medical device recall Z-2952-2026
Ongoing recall by Intersurgical Inc, reported 2026-08-26, distributed nationwide. Devices could potentially be occluded or partially occluded.
| Recall number | Z-2952-2026 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Ongoing |
| Voluntary or mandated | Voluntary |
| Recalling firm | Intersurgical Inc, East Syracuse, NY, United States |
| Recall initiated | 2026-06-15 |
| Classified | 2026-08-14 |
| Reported by FDA | 2026-08-26 |
| Distributed | Nationwide (US) |
| Quantity | 21,269 units |
| UPC / GTIN / UDI-DI | 05030267044450, 05030267050185 |
| Lot numbers | 32121232, 32208193, 32400267, 32403734, 32408819, 32409672, 32416545, 32427064, 32605471, 32606405, 32606850, 32607154 |
| Model numbers | 1100050 |
Product
One-Piece Guedel Airway, size 00, ISO 5.0, Blue. Oropharyngeal Airway Device.
Reason for recall
Devices could potentially be occluded or partially occluded.
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-2952-2026. 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.