Olympus Cystoscope Sheath Recall: Incompatibility with GreenLight Laser Risk
Olymp: Olympus recalls cystoscope outer sheath model WA22810A due to incompatibility with GreenLight Laser for BPH therapy, risking device tip damage.
Use caution until it’s fixed
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.
Contact the company
What happened, in plain English
Olympus is recalling its cystoscope outer sheath model WA22810A because it can cause damage to the device tip when used with GreenLight Laser for BPH therapy. This incompatibility may lead to improper treatment or injury during procedures. Read more at govinfonow.com/recall/54029-olympus-cystoscope-sheath-recall-incompatibility-with-greenlight-laser-risk.
Source Summary by GovInfoNow · govinfonow.com/recall/54029-olympus-cystoscope-sheath-recall-incompatibility-with-greenlight-laser-risk · Updated August 19, 2026 · FDA enforcement record: FDA #Z-1437-2026
Cite this page
“Olympus Cystoscope Sheath Recall: Incompatibility with GreenLight Laser Risk.” GovInfoNow, updated August 19, 2026. https://govinfonow.com/recall/54029-olympus-cystoscope-sheath-recall-incompatibility-with-greenlight-laser-risk. Based on FDA recall #Z-1437-2026 (https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-1437-2026%22&limit=1).
Why it’s dangerous
The cystoscope outer sheath is incompatible with GreenLight Laser systems used for BPH treatment. When used together, this incompatibility can damage the device tip, potentially causing improper treatment or injury during procedures.
Who’s affected
Patients undergoing BPH therapy using GreenLight Laser with this specific cystoscope sheath are most at risk. Healthcare providers using the product in clinical settings may also be affected.
How to tell if you have this one
Check for model WA22810A or WA2280A on the sheath. The product was sold with UDI 04042761051729 across all lots.
- Brand
Olympus- Category
Medical device
What to do — step by step
Check Compatibility
Verify if the cystoscope sheath is used with GreenLight Laser for BPH therapy.
Contact Olympus
Reach out to Olympus Corporation of the Americas for guidance on safe use or replacement.
Where it went and when
Where it was distributed
Distributed nationwide.
FDA distribution: “Distribution US nationwide.” States read from FDA’s own wording; “not listed” means the notice does not name it.
Distributed nationwide.
Recall timeline
FDA published this recall 18 months after the firm started it.
- Firm started the recall
- FDA classified it Class II
- Published in FDA’s Enforcement Report
Dates from the agency record only; steps without a date are left out.
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Where this comes from
The facts (hazard, remedy, dates, manufacturer) are pulled from the official FDA recall record. The plain-language summary and step-by-step checklist are written by GovInfoNow to make the official notice easier to act on — they don’t replace it.
- Official source: FDA Recall #Z-1437-2026 (September 13, 2024) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for Z-1437-2026 to see it in context.
- Plain-language summary written by qwen3:4b on August 19, 2026, from the official record above. Not reviewed by a person — if it conflicts with the FDA notice, the notice is correct. Report an error on this page.
- GovInfoNow is an independent service and is not a government agency. We republish official FDA recall data; we don’t issue, amend or administer recalls.