Olympus recalls cystoscope outer sheaths (model WA22810A) due to potential tip damage when used with GreenLight laser probes. Affected units sold from 2020 onward.
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.
Take action
Contact the company
📍Recalling firmOlympus Corporation of the Americas3500 Corporate Pkwy · Center Valley, PA 18034-8229
“Olymp: Cystoscope Outer Sheath Recall - Laser Compatibility Risk.” GovInfoNow, updated August 19, 2026. https://govinfonow.com/recall/54025-olymp-cystoscope-outer-sheath-recall-laser-compatibility-risk. Based on FDA recall #Z-0351-2025 (https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-0351-2025%22&limit=1).
The FDA announced on September 13, 2024, that Olympus Corporation of the Americas is recalling its Cystoscope Outer Sheath (Model WA22810A) due to the potential for a damaged tip during laser probe use. The company is removing a compatibility statement with GreenLight Laser for BPH therapy from the instructions.
How to tell if you have it
Brand: Olympus
Product Name: Cystoscope Outer Sheath
Model/Catalog Number: WA22810A
Lot#: All lots
The hazard
The recall addresses the potential for a damaged tip during use of a laser probe. This risk arises because Olympus is removing the statement of compatibility with a GreenLight Laser for BPH therapy from the Instruction for Use.
Context
GovInfoNow's records show Olympus Corporation of the Americas has issued 133 other recalls since August 18, 2017. Recent brand recalls include an Olympus Tripp-Lite P580-025 DisplayPort Cable recall on August 27, 2026, and an Olympus M3 Gold Autoclavable Foroblique Telescope 30 recall on August 24, 2026. Other recent recalls of similar products include an Oscor Abiomed Introducer Kit Recall on June 10, 2026, a Wilson-Cook Instinct Plus Endoscopic Clipping Device Recall on March 3, 2026, and an Oertli 23G Laser Probes recall on December 16, 2025.
How to tell if you have this one
Check for model number WA22810A on the sheath. These were sold starting in 2020 with UDI 04042761051729 across all lots.
Brand
Olympus
Category
Medical device
Based on the official FDA remedy
What to do — step by step
Check Compatibility
Verify if the sheath is used with GreenLight laser probes for BPH therapy by checking the product's instruction manual.
Where it went and when
Where it was distributed
Distributed nationwide; the notice names 45 states.
Named in the notice
Covered by “nationwide”
Not listed
FDA distribution: “US Nationwide distribution including in the states of AK, AL, AR, AZ, CA, CO, CT, FL, GA, HI, ID, IL, IN, KS, KY, LA, MA, MD, ME, MI, MN, MS, MT, NC, ND, NE, NH, NJ, NM, NV, NY, OH, OR, PA, SC, SD, TN, TX, UT, VA, VT, WA, WI, WV, WY.” States read from FDA’s own wording; “not listed” means the notice does not name it.
Named in the notice: Alabama, Alaska, Arizona, Arkansas, California, Colorado, Connecticut, Florida, Georgia, Hawaii, Idaho, Illinois, Indiana, Kansas, Kentucky, Louisiana, Maine, Maryland, Massachusetts, Michigan, Minnesota, Mississippi, Montana, Nebraska, Nevada, New Hampshire, New Jersey, New Mexico, New York, North Carolina, North Dakota, Ohio, Oregon, Pennsylvania, South Carolina, South Dakota, Tennessee, Texas, Utah, Vermont, Virginia, Washington, West Virginia, Wisconsin, Wyoming.
Recall timeline
FDA published this recall 2 months after the firm started it.
1Firm started the recall
2FDA classified it Class II
3Published in FDA’s Enforcement Report
Dates from the agency record only; steps without a date are left out.
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-0351-2025 (September 13, 2024) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for Z-0351-2025 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.