FDA-Device2026-03-04Class IIPROCESSING DEFECT
Olympus Cystoscope Outer Sheath WA22810A recalled for laser incompatibility damage
What this means
Olympus is recalling the Cystoscope Outer Sheath model WA22810A because it is incompatible with GreenLight Laser systems used for prostate (BPH) treatment. Using this sheath with the laser can damage the tip of the device, potentially affecting the safety and function of the cystoscope.
- Stop using Olympus Cystoscope Outer Sheath model WA22810A with GreenLight Laser systems immediately.
- Contact Olympus Corporation of the Americas for instructions on returning or replacing the affected sheath.
- Check your facility's inventory for lot numbers and the UDI 04042761051729.
The agency's original wording
Hazard
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.
Intended for
Adults
Illnesses reported
None reported
Sold states
Distribution US nationwide.
Affected count
633 units
Manufactured in
3500 Corporate Pkwy, N/A, Center Valley, PA, United States
Products
Olympus Cystoscope Outer Sheath; Model/Catalog number: WA22810A;
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1437-2026More Olympus recalls
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