FDA Device recall Z-1437-2026
Olympus Cystoscope Outer Sheath
- FDA Device
- Class II
- ongoing
- Published 2026-03-04
On 2026-03-04 the FDA classified a Class II recall of Olympus Cystoscope Outer Sheath by Olympus, citing 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.
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-1437-2026 |
| Classification | Class II |
| Status | ongoing |
| Initiated | 2024-09-13 |
| Published | 2026-03-04 |
| Last updated | 2026-09-13 11:58 UTC |
| Company | Olympus |
| Distribution | US |
Product
Olympus Cystoscope Outer Sheath; Model/Catalog number: WA22810A;
Reason
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.
Identifiers
| code_info | Model: WA2280A; UDI: 04042761051729; Lot#: All lots; |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:58 UTC. Current status: ongoing.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-1437-2026%22
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