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.
Olympus is recalling cystoscope outer sheaths (model WA22810A) because they may cause tip damage when used with GreenLight laser probes. This could lead to complications during medical procedures.
The outer sheath has a compatibility statement with GreenLight laser probes that could cause tip damage during use. This might lead to complications in medical procedures if the sheath is used incorrectly with laser probes.
Medical professionals using the cystoscope outer sheaths with GreenLight laser probes for BPH therapy are most at risk. Patients receiving these procedures may also be affected.
Check for model number WA22810A on the sheath. These were sold starting in 2020 with UDI 04042761051729 across all lots.
Verify if the sheath is used with GreenLight laser probes for BPH therapy by checking the product's instruction manual.
The recall affects medical professionals using the sheaths with laser probes; patients are not directly affected unless they undergo procedures using the recalled sheaths.
Look for model number WA22810A on the sheath, which was sold starting in 2020 with UDI 04042761051729 across all lots.
The recall does not require immediate action; check compatibility with laser probes before use.
We’ve drafted a message you can send Olympus to request your refund or repair — edit it as you like.
Subject: Recall Z-0351-2025 — Olympus Olympus Hello, I own a Olympus that is covered by recall Z-0351-2025 from Olympus. I’m writing to arrange the remedy described in the recall (a refund, repair, or replacement as applicable). Could you please tell me the next steps to resolve this? Thank you.
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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.
