FDA recall, , Moderate risk
Olympus Cystoscope Outer Sheath
The Olympus Cystoscope Outer Sheath is being removed due to incompatibility with a GreenLight Laser that could damage the device tip.
Summary by Recall Canary from the FDA notice
What happened
Olympus Corporation of the Americas, located in Center Valley, Pennsylvania, is removing the Olympus Cystoscope Outer Sheath due to incompatibility when used in conjunction with a GreenLight Laser for BPH therapy which could damage the tip of the device. The company began the recall on September 13, 2024, and the action was added to the FDA's Enforcement Report on February 20, 2026.
The recall affects 633 units distributed US nationwide. The FDA classified the recall on February 20, 2026, and it was included in the agency's weekly enforcement report on March 4, 2026.
What to do
We don't have product-specific instructions for this recall. FDA's general advice for medical device recalls:
- A device recall doesn't always mean you must stop using it: it may need to be checked, adjusted or fixed.
- Talk to your health care provider before you stop using it.
Is yours affected?
Match the model number and UDI-DI listed under your product.
A UDI-DI is the device identifier printed with the barcode on the device label.
Olympus Cystoscope Outer Sheath
- Model number
- WA22810A
- UDI-DI
- 04042761051729
- Lot code
- All lots
Recall details
- Company began the recall
- Sold in
Distribution US nationwide.
- Company
- Olympus Corporation of the AmericasCenter Valley, Pennsylvania
- Hazard
- Device defect
- Risk
Moderate risk
Using it may cause short-term health problems, or ones that treatment can reverse. Serious harm is unlikely.
FDA Class II recall · How risk is rated
- Event ID
- 98300
- Recall number
- Z-1437-2026
- Quantity recalled
- 633 units
All recalls from Olympus Corporation of the Americas
Timeline
FDA's Enforcement Report is its public list of recalls; FDA adds a recall when it posts it and publishes the list weekly.
Company began the recall
Added to FDA's Enforcement Report · Classified by FDA
In FDA's weekly enforcement report
Listed on Recall Canary
