Intersurgical Solus Standard — Class II medical device recall Z-0096-2023
Terminated recall by Intersurgical Inc, reported 2022-10-26, distributed in OH, TN, TX. Printing error on the device, size 3 Solus Standard laryngeal mask airway has been incorrectly marked with siz
| Recall number | Z-0096-2023 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Intersurgical Inc, East Syracuse, NY, United States |
| Recall initiated | 2022-08-29 |
| Classified | 2022-10-17 |
| Reported by FDA | 2022-10-26 |
| Terminated | 2023-10-19 |
| Distributed | OH, TN, TX |
| Quantity | 340 units |
| UPC / GTIN / UDI-DI | 05030267046959, 05030267073511 |
| Lot numbers | 32204071 |
| Model numbers | 8003000 |
Product
Intersurgical Solus Standard, laryngeal mask airway, size 3, small adult, 30-50kg Model Number: 8003000
Reason for recall
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
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-0096-2023. 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.