Spiration Valve System — Class II medical device recall Z-0551-2022
Ongoing recall by Olympus Corporation of the Americas, reported 2022-02-09, distributed nationwide. Mislabeled Patient Charge Label indicating model number SVS-V7-00 (7mm) instead of SVS-V9-00 (9mm)
| Recall number | Z-0551-2022 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Ongoing |
| Voluntary or mandated | Voluntary |
| Recalling firm | Olympus Corporation of the Americas, Center Valley, PA, United States |
| Recall initiated | 2021-12-23 |
| Classified | 2022-02-01 |
| Reported by FDA | 2022-02-09 |
| Distributed | Nationwide (US) |
| Quantity | 35 units |
| Reason classes | labeling |
| UPC / GTIN / UDI-DI | 00896506002309 |
| Lot numbers | WS147887-01 |
| Model numbers | SVS-V9-00 |
| Expiration dates | 2024-04-30 |
Product
Spiration Valve System (SVS) Valve in Cartridge -A one-way endobronchial valves indicated for adult patients with shortness of breath and hyperinflation Model Number: SVS-V9-00
Reason for recall
Mislabeled Patient Charge Label indicating model number SVS-V7-00 (7mm) instead of SVS-V9-00 (9mm)
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-0551-2022. 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.