Is Olympus CYSTONEPHROFIBERSCOPE Model: CYF-5 recalled?

Medium RiskFDA Device

Olympus Corporation of the Americas: Incorrect adhesive used to secure the diopter ring and nameplate ring. Improperly connected diopter ring may result in the loss of adjustment function leading to a blurred field of vision and unintentional contact with the patients body and in rare cases perforation in the urinary tract/renal pelvis.

Agency Publication Date: June 13, 2022

Affected Products

Product: Olympus CYSTONEPHROFIBERSCOPE Model: CYF-5

UDI-DI: 04953170339417 Serial Number: 2456630 7171632 2769732 W501648A 2355088 2557155 2972060

Product: Olympus URETERO-RENO FIBERSCOPE Model: URF-P6

UDI-DI: 04953170340802 Serial Number: 2836210 2834747I

Product: Olympus URETERO-RENO FIBERSCOPE Model: URF-P6R

UDI-DI: 04953170340833 Serial Number: 2836209F 2835978 2837272 2836299

Additional Information

Agency: Food and Drug Administration (FDA)

Event ID: 90195

Status: Active

Manufacturer: Olympus Corporation of the Americas

Manufactured In: United States

Units Affected: 3 products (7 units; 2 units; 4 units)

Were You Affected by This Recall?

If you or a family member were harmed by this recalled product, you may have legal rights. Consider consulting a consumer protection attorney to understand your options for compensation.

Find an Attorney

This is general information, not legal advice. Go Backs is not a law firm and does not provide legal services.

AI-Enhanced Content: The summary, action steps, and risk assessment on this page were generated by AI from official government recall data to improve readability. This is not legal or medical advice. Always refer to the official agency sources below for authoritative information.

Sources: FDA iRES · Raw API Response

openFDA Disclaimer: This recall information is sourced from the openFDA API. Do not rely on openFDA to make decisions regarding medical care. While we make every effort to ensure that data is accurate, you should assume all results are unvalidated. Refer to the openFDA terms of service for more information.