FDA Device recall Z-0551-2022
Spiration Valve System (SVS) Valve in Cartridge -A one-way endobronchial valves indicated for adult patients with shortness of breath and h…
- FDA Device
- Class II
- ongoing
- Published 2022-02-09
On 2022-02-09 the FDA classified a Class II recall of Spiration Valve System (SVS) Valve in Cartridge -A one-way endobronchial valves indicated for adult patients with shortness of breath and h… by Olympus, citing mislabeled Patient Charge Label indicating model number SVS-V7-00 (7mm) instead of SVS-V9-00 (9mm).
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-0551-2022 |
| Classification | Class II |
| Status | ongoing |
| Initiated | 2021-12-23 |
| Published | 2022-02-09 |
| Last updated | 2026-09-13 11:56 UTC |
| Company | Olympus |
| Distribution | US |
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
Mislabeled Patient Charge Label indicating model number SVS-V7-00 (7mm) instead of SVS-V9-00 (9mm)
Identifiers
| code_info | Lot Number: WS147887-01 UDI: 896506002309 Expiration Date: 4/30/2024 |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:56 UTC. Current status: ongoing.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-0551-2022%22
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