Solus Flexible wire-reinforced laryngeal mask airways under the… — Class II medical device recall Z-0208-2018
Terminated recall by Intersurgical Inc, reported 2017-12-13, distributed in IL, KY, NY, OH, VA. A defect in the wire-reinforced tubing may result in a partial of total occlusion when the cuff is over-inflat
| Recall number | Z-0208-2018 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Intersurgical Inc, E. Syracuse, NY, United States |
| Recall initiated | 2017-04-03 |
| Classified | 2017-12-07 |
| Reported by FDA | 2017-12-13 |
| Terminated | 2019-06-17 |
| Distributed | IL, KY, NY, OH, VA |
| Countries outside the US | CA, MX |
| Reason classes | device malfunction |
| Lot numbers | 31402822, 31610791 |
| Model numbers | 8002001, 8003001, 8004001, 8005001, 8025001 |
Product
Solus Flexible wire-reinforced laryngeal mask airways under the following sizes: 1) small pediatric size 2 catalog #8002001, 2) large pediatric size 2.5 catalog #8025001, 3) small adult size 3 catalog #8003001, 4) medium adult size 4 catalog #8004001 and 5) large adult size 5 catalog #8005001 Patent airway management.
Reason for recall
A defect in the wire-reinforced tubing may result in a partial of total occlusion when the cuff is over-inflated.
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-0208-2018. 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.