Model No — Class II medical device recall Z-0689-2024
Ongoing recall by Shirakawa Olympus Co., Ltd., reported 2024-01-17, distributed nationwide. Olympus has updated the instructions for use: Reusable cleaning brushes have been removed from the manual clea
| Recall number | Z-0689-2024 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Ongoing |
| Voluntary or mandated | Voluntary |
| Recalling firm | Shirakawa Olympus Co., Ltd., Nishishirakawa-Gun, Japan |
| Recall initiated | 2023-12-04 |
| Classified | 2024-01-09 |
| Reported by FDA | 2024-01-17 |
| Distributed | Nationwide (US) |
| UPC / GTIN / UDI-DI | 04953170310461, 04953170411250 |
Product
Model No. CYF-VH, CYSTO-NEPHRO VIDEOSCOPE
Reason for recall
Olympus has updated the instructions for use: Reusable cleaning brushes have been removed from the manual cleaning. Single use brushes remain compatible.
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-0689-2024. 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.