URETERO-RENO FIBERSCOPE recallZ-1264-2022 · Olympus Corporation of the Americas · initiated Apr 20, 2022
Open, Classified
Is my device affected?
- Compare the model, catalog and lot or serial numbers on your device or its packaging with the code information below. A recall usually covers only specific models or lots.
- If yours is listed, follow the instructions from Olympus Corporation of the Americas or your healthcare provider. The company's action is summarized under what the company is doing.
- Do not stop using a prescribed or implanted device on your own — talk to your healthcare provider first.
Where to find your model and lot numbers · What recall classes and statuses mean
Why it was recalled
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.
FDA root cause category: Nonconforming Material/Component
What the company is doing
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.
Recall details
- Recall number
- Z-1264-2022
- Status
- Open, Classified
- Initiated by the company
- Apr 20, 2022
- Recalling firm
- Olympus Corporation of the Americas
- Quantity
- 4 units
- Product code
- FGB
- FDA submissions
- K172298
- Distribution
- CA FL MA MD MI NJ OH PR WI
Product description
Olympus URETERO-RENO FIBERSCOPE Model: URF-P6R
Code information (models, lots, serial numbers)
UDI-DI: 04953170340833 Serial Number: 2836209F 2835978 2837272 2836299
Devices named in this recall
1 device in the FDA device registry whose identifier appears in the recall's code information.
- URETERO-RENO FIBERSCOPE OLYMPUS URF-P6ROlympus Medical Systems Corp. · Ureteroscope and accessories, flexible/rigid2 recalls190 reports
Product lines
Other products in the same recall event
The FDA groups related products into one recall event (event 90195).
- Z-1262-2022 · Open, ClassifiedOlympus CYSTONEPHROFIBERSCOPE Model: CYF-5
- Z-1263-2022 · Open, ClassifiedOlympus URETERO-RENO FIBERSCOPE Model: URF-P6
Sources and updates
- Recall record: FDA Medical Device Recalls, file dated Oct 16, 2026 · View the FDA recall notice ↗
- Devices: FDA GUDID, file dated Oct 13, 2026. Devices are linked when their identifier (with a valid check digit) appears in the recall's code information.
- Page last rebuilt: Oct 16, 2026. Text above is shown as published by the FDA.
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