Shirakawa Olympus Co., Ltd. Azaokamiyama 3-1 Oazaodakura; Nishigo-Mura Nishishirakawa-Gun Japan Model No. CYF-V2, VISERA Cysto-Nephro Videoscope Recall
Check Your Product
According to the U.S. Food and Drug Administration (FDA)
Product
Model No. CYF-V2, VISERA Cysto-Nephro Videoscope
Brand
Shirakawa Olympus Co., Ltd. Azaokamiyama 3-1 Oazaodakura; Nishigo-Mura Nishishirakawa-Gun Japan
Lot Codes / Batch Numbers
UDI-DI: 04953170287091 04953170339431 04953170411199 All serial numbers
Products Sold
UDI-DI: 04953170287091 04953170339431 04953170411199 All serial numbers
Shirakawa Olympus Co., Ltd. Azaokamiyama 3-1 Oazaodakura; Nishigo-Mura Nishishirakawa-Gun Japan is recalling Model No. CYF-V2, VISERA Cysto-Nephro Videoscope due to Olympus has updated the instructions for use: Reusable cleaning brushes have been removed from the manual cleaning. Single use brushes remain compatib. Based on FDA medical device recall database.
Summary derived from FDA notice
Reason for Recall
As stated by FDA
Olympus has updated the instructions for use: Reusable cleaning brushes have been removed from the manual cleaning. Single use brushes remain compatible.
Recommended Action
Per FDA guidance
On December 4, 2023, the firm notified customers of the recall via URGENT MEDICAL DEVICE CORRECTION letters. Customers were informed of the updates to the instructions for use (IFU). Customers were instructed to ensure all personnel are completely knowledgeable and thoroughly trained on the changes to the reprocessing instructions. Please locate and replace any on-hand copies of the IFU with the updated version. The most current version of the Instructions for Use can be obtained from the Olympus Connect customer web portal at https://www.OlympusConnect.com. New users will need to register. Once registered select the Product Support button on the left navigation bar, select the [Reprocessing Manuals] button, locate the BF-P190 and BF-XP190 Instructions for Use and select the [Download] button. If you require additional information, please contact the firm directly by phone at (647) 999-3203 or by e-mail at Cynthia.Ow@olympus.com
Verify this information on the official source
For complete details and official instructions, check the U.S. Food and Drug Administration (FDA) directly.
View official FDA recall noticePage updated: Jan 10, 2026