Olympus Uretero-Reno Fiberscope Recalled for Defective Adhesive and Vision Loss
The Olympus URETERO-RENO FIBERSCOPE Model URF-P6 is recalled for incorrect adhesive securing the diopter ring. The defect may cause loss of adjustment function, blurred vision, and in rare cases, urinary tract perforation.
What this means for you
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: FDA Class II device with potential for serious injury (urinary tract perforation) but no reported illnesses or injuries. The hazard is characterized as occurring in rare cases, making it a risk-of-harm product where injury has not yet been reported.
Plain-English summary
The Olympus URETERO-RENO FIBERSCOPE Model URF-P6 is being recalled due to incorrect adhesive used to secure the diopter ring and nameplate ring. An improperly connected diopter ring can result in loss of the adjustment function.
When adjustment function is lost, the device may exhibit a blurred field of vision. This can lead to unintended contact between the scope and the patient's body. In rare cases, this may result in perforation of the urinary tract or renal pelvis.
Two units have been identified and are distributed across California, Florida, Massachusetts, Maryland, Michigan, New Jersey, Ohio, Puerto Rico, and Wisconsin.
The recalled product
- Product
- Olympus URETERO-RENO FIBERSCOPE Model: URF-P6
- Manufacturer
- Olympus Corporation of the Americas
- Affected units
- 2
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (1)
- UDI-DI: 04953170340802 Serial Number: 2836210 2834747I
Distribution
Part of a larger recall action
This product is one of 3 recalled by Olympus Corporation of the Americas under a single FDA (Devices) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.
See all 3 products in this recall →Related recalls
Same manufacturer · Olympus Corporation of the Americas
See all →- ModerateOlympus Recalls PowerSeal Sealer Due to Incorrect Outer Box Labeling
FDA (Devices) · 2026-09-02
- ModerateOlympus 4K UHD LCD Monitors Recalled Due to Potential Connector Faults
FDA (Devices) · 2026-07-29
- HighOlympus High Flow Insufflation Unit UHI-4 Recalled Due to Display and Air Delivery Failure
FDA (Devices) · 2026-07-29
- HighOlympus Toomey Evacuator 30cc medical device sterilization parameters recalled
FDA (Devices) · 2026-07-22
- HighOlympus Toomey Evacuator 50cc with Adaptor sterilization recall
FDA (Devices) · 2026-07-22
Same hazard · adhesive defect
See all →- HighArrow Epidural Catheter Kits Recalled Due to Adhesive Manufacturing Defect
FDA (Devices) · 2026-04-29
- HighHUDSON RCI mBrace ET Tube Holder Risks Facial Dermal Injury
FDA (Devices) · 2024-12-25
- HighPrescription Dextroamphetamine Patches Recalled for Defective Adhesive System
FDA (Drugs) · 2024-11-27
- HighGE Allia IGS Fluoroscopic X-Ray Systems Adhesive Bolt Defect
FDA (Devices) · 2024-05-15
- ModerateNatus Sleep Supplies Recalled for Conductive Adhesive Gel Quality Defects
FDA (Devices) · 2024-03-27