URETERO-RENO VIDEOSCOPE recallZ-1116-2022 · Olympus Corporation of the Americas · initiated Mar 25, 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
The bending section of the URF-V2 may crack, resulting in an abnormal shape or abnormal angulation of the bending section.
FDA root cause category: Process change control
What the company is doing
On March 25, 2022, the firm contacted the affected consignee to inform them that certain manufacturing changes by a supplier led to the possibility that a part within the bending section may crack. Olympus repaired the affected URF-V2 unit free of charge.
Recall details
- Recall number
- Z-1116-2022
- Status
- Open, Classified
- Initiated by the company
- Mar 25, 2022
- Recalling firm
- Olympus Corporation of the Americas
- Quantity
- 1
- Product code
- NWB
- FDA submissions
- K172246
- Distribution
- US Nationwide distribution in the state of AZ.
Product description
Olympus Uretero-reno videoscope, Model No. URF-V2
Code information (models, lots, serial numbers)
1 unit, serial number 2825505F UDI 04953170343582
Devices named in this recall
1 device in the FDA device registry whose identifier appears in the recall's code information.
- URETERO-RENO VIDEOSCOPE OLYMPUS URF-V2Olympus Medical Systems Corp. · Ureteroscope and accessories, flexible/rigid2 recalls397 reports
Product lines
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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