Class II — Intersurgical Inc
| Recalling firm | INTERSURGICAL, INC. |
|---|---|
| Registered facility | INTERSURGICAL, INC. (the firm's only registered facility) |
| Classification | Class II |
| Status | Ongoing |
| Reason | Devices could potentially be occluded or partially occluded. |
| Product | One-Piece Guedel Airway, size 00, ISO 5.0, Blue. Oropharyngeal Airway Device. |
| Quantity | 21,269 units |
| Distribution | US Nationwide distribution in the states of CT, FL, IN, MI, OH & VA. |
| Initiated | 2026-06-15 |
| Classified | 2026-08-14 |
| Recall number | Z-2952-2026 |
| Initiation | Voluntary: Firm initiated |
Source: U.S. FDA via openFDA (opens in a new tab) (device registration & enforcement). Data as of 2026-10-06. Verify this recall record at FDA → (opens in a new tab)
Cite this record
RegWarden. “Class II recall — Intersurgical Inc (Z-2952-2026).” Compiled from U.S. FDA public records (openFDA; FDA Data Dashboard). Data as of 2026-10-06. https://regwarden.com/recall/99284/
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