FDA-Device2026-03-04Class IIPROCESSING DEFECT
Olympus Cystoscope Outer Sheath WA22810A recalled for laser incompatibility damage
OTHERNationwide distribution
Stop using Olympus Cystoscope Outer Sheath WA22810A
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.
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.
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 Corporation of the Americas recalls
- FDA-Device2026-04-08Olympus SOLTIVE Premium laser system recalled for defective power supply
- FDA-Device2026-04-08Olympus SOLTIVE Pro SuperPulsed Laser System recalled for power supply defect
- FDA-Device2026-04-01Olympus PKS Cutting Forceps recalled for defective welds causing jaw breakage
- FDA-Device2026-04-01Olympus MAJ-1443 and MAJ-1444 endoscope suction valves no longer compatible with OER-Pro and OER-Elite reprocessors
- FDA-Device2026-04-01Olympus PKS Cutting Forceps recalled for defective welds causing jaw breakage
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