Z-1262-2022Class II

Olympus CYSTONEPHROFIBERSCOPE Model: CYF-5

Name: Z-1262-2022 Olympus CYSTONEPHROFIBERSCOPE Model: CYF-5
Creator: Olympus Corporation of the Americas
Published: 2022-04-20
License: https://open.fda.gov/license/

OLYMPUS Corporation of the Americas / initiated 2022-04-20 / Open, Classified / root cause: manufacturing process

FDA source

Olympus Corporation of the Americas began a recall of Olympus CYSTONEPHROFIBERSCOPE Model: CYF-5 on 2022-04-20. FDA classified it as Class II and gives the reason as "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...". As of 2026-09-10, the recall status on record is Open, Classified, and MDM tags the root cause as manufacturing process.

Recall record

Recall number: Z-1262-2022
Classification: Class II
Status: Open, Classified
Initiated: 2022-04-20
Posted: 2022-06-13
Recalling firm: OLYMPUS Corporation of the Americas
Product: Olympus CYSTONEPHROFIBERSCOPE Model: CYF-5
Product code: FAJ Cystoscope And Accessories, Flexible/Rigid
Reason for recall: 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.
Root cause tag: manufacturing process
FDA root cause: Nonconforming Material/Component
Action: Olympus notified Urgent Medical Device Correction letter on 4/20/22 via email. Letter states reason for recall, health risk and action to take: 1. Identify the affected model and serial number in the subject of this letter. The model and serial number can be found on the device as illustrated. 2. An Olympus representative will contact you to make arrangements for return of your affected device. Olympus will repair your unit free of charge. In the meantime, follow the instruction manual for inspection of the device before use. Should any irregularities be identified, including a loose parts, do not use the device and contact Olympus for repair. 3. Olympus will arrange for a service loaner in an effort not to disrupt clinical care. Contact me directly at 647-999-3203 or at [email protected] for any additional information or support concerning this matter.
Quantity in commerce: 7 units
Distribution: CA FL MA MD MI NJ OH PR WI
Product codes and lots: UDI-DI: 04953170339417 Serial Number: 2456630 7171632 2769732 W501648A 2355088 2557155 2972060

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-1262-2022
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-1262-2022	Class II	Ongoing	Voluntary: Firm initiated	2022-06-22	2022-06-13
Z-1263-2022	Class II	Ongoing	Voluntary: Firm initiated	2022-06-22	2022-06-13
Z-1264-2022	Class II	Ongoing	Voluntary: Firm initiated	2022-06-22	2022-06-13

Product code FAJ

K993041Class IIOlympus Xcyf-1T3 Oes Cystofiberscope/nephrofiberscope Accessories and Ancillary EquipmentThe Olympus Optical Co. / cleared 2000-03-30

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)