The Recall Desk
Severity pendingFDA (Devices)·Z-1437-2026·Announced 2026-03-04

Olympus Cystoscope Outer Sheath; Model/Catalog number: WA22810A;

Pending LLM rewrite. Source: FDA_DEVICE Z-1437-2026.

Severity not yet assessed

We have not scored this recall against our rubric yet, so we are not showing a severity rating or our usual guidance. The agency’s own notice below is the authoritative source — read it first.

Plain-English summary

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.

The recalled product

Product
Olympus Cystoscope Outer Sheath; Model/Catalog number: WA22810A;
Manufacturer
Olympus Corporation of the Americas

Is your product affected?

Check your packaging against the codes below. If any of them match, the product is part of this recall.

Lot numbers (3)

  • Model: WA2280A
  • UDI: 04042761051729
  • Lot#: All lots

Distribution

Distributed nationwide across the United States.