Brand Name: Olympus Product Name: Cystoscope Outer Sheath… — Class II medical device recall Z-0351-2025
Ongoing recall by Olympus Corporation of the Americas, reported 2024-11-20, distributed nationwide. Olympus is removing the statement of compatibility with a GreenLight Laser for BPH therapy from the Instructio
| Recall number | Z-0351-2025 |
|---|---|
| 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 | 2024-09-13 |
| Classified | 2024-11-08 |
| Reported by FDA | 2024-11-20 |
| Distributed | Nationwide (US) |
| Quantity | 738 units |
| UPC / GTIN / UDI-DI | 04042761051729 |
| Model numbers | WA2280A, WA22810A |
Product
Brand Name: Olympus Product Name: Cystoscope Outer Sheath Model/Catalog Number: WA22810A Software Version: N/A Product Description: Outer sheaths can be combined with rigid Telescopes. Component: N/A
Reason for recall
Olympus is removing the statement of compatibility with a GreenLight Laser for BPH therapy from the Instruction for Use (IFU) due to the potential for a damaged tip during use of a laser probe.
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-0351-2025. 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.