VISERA Cysto-Nephro Videoscope Model CYF-V2: Reusable Brush Cleaning Update
Olympus is updating instructions for the VISERA Cysto-Nephro Videoscope (Model CYF-V2) nationwide, removing reusable brushes from manual cleaning procedures. Single-use brushes remain compatible.
What this means for you
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: This is a Class II medical device recall with no reported illnesses or injuries. The hazard relates to cleaning procedures for a device used in minimally invasive procedures. Per the severity rubric, Class II recalls without reported harm are capped at score 3 when the identified hazard is theoretical.
Plain-English summary
The FDA has issued a Class II recall for the VISERA Cysto-Nephro Videoscope (Model CYF-V2) manufactured by Shirakawa Olympus Co., Ltd. Olympus has updated the device's instructions for use, removing reusable cleaning brushes from the manual cleaning procedure. Single-use brushes remain compatible with the device.
The recall affects all serial numbers of this model, with approximately 2,210 units distributed in the United States and 6,002 units distributed internationally.
The recalled product
- Product
- Model No. CYF-V2, VISERA Cysto-Nephro Videoscope
- Manufacturer
- Shirakawa Olympus Co., Ltd.
- Hazard
- inadequate-cleaning
- cross-contamination
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (1)
- UDI-DI: 04953170287091 04953170339431 04953170411199 All serial numbers
Distribution
Distributed nationwide across the United States.
Related recalls
Same category
- HighPhilips Azurion X-Ray Systems Table Movement Control Defect Recall
FDA (Devices) · 2026-05-27
- HighAzurion X-ray System Deaeration Hose May Degrade and Cause Oil Leakage
FDA (Devices) · 2026-05-27
- HighMedtronic DLP Retrograde Cannula Cardiopulmonary Bypass Catheter Recall
FDA (Devices) · 2026-05-27
- HighMedtronic DLP Retrograde Cannula cardiopulmonary bypass catheter
FDA (Devices) · 2026-05-27
- HighTangent Single Use Digital Catheter Recalled for Distal Shaft Fractures
FDA (Devices) · 2026-05-27