Olympus Cystoscope Outer Sheath — Class II medical device recall Z-1437-2026
Ongoing recall by Olympus Corporation of the Americas, reported 2026-03-04, distributed nationwide. Product being removed due to incompatibility when used in conjunction with a GreenLight Laser for BPH therapy
| Recall number | Z-1437-2026 |
|---|---|
| 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 | 2026-02-20 |
| Reported by FDA | 2026-03-04 |
| Distributed | Nationwide (US) |
| Quantity | 633 units |
| UPC / GTIN / UDI-DI | 04042761051729 |
| Model numbers | WA2280A, WA22810A |
Product
Olympus Cystoscope Outer Sheath; Model/Catalog number: WA22810A;
Reason for recall
Product being removed due to incompatibility when used in conjunction with a GreenLight Laser for BPH therapy which could damage the tip of the device.
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-1437-2026. 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.