Class II — Intersurgical Inc
| Recalling firm | INTERSURGICAL, INC. |
|---|---|
| Registered facility | INTERSURGICAL, INC. (the firm's only registered facility) |
| Classification | Class II |
| Status | Terminated |
| Reason | Printing error on the device, size 3 Solus Standard laryngeal mask airway has been incorrectly marked with size 4 information (includes the number 4 as a size identifier, patient weight and maximum inflation volume on the airway tube and the marking #4 on the inflation line pilot balloon) may pose health risk to the patient |
| Product | Intersurgical Solus Standard, laryngeal mask airway, size 3, small adult, 30-50kg Model Number: 8003000 |
| Quantity | 340 pieces |
| Distribution | OH, TN, TX |
| Initiated | 2022-08-29 |
| Classified | 2022-10-17 |
| Terminated | 2023-10-19 |
| Recall number | Z-0096-2023 |
| 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-0096-2023).” Compiled from U.S. FDA public records (openFDA; FDA Data Dashboard). Data as of 2026-10-06. https://regwarden.com/recall/90855/
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