Olympus Recalls URF-P6 Uretero-reno Fiberscopes Due to Tissue Trauma Risk
Olympus is recalling URF-P6 and URF-P6R uretero-reno fiberscopes due to adverse events involving tissue trauma and stuck insertion tubes reported in similar devices.
What this means for you
Illness, injury, or structural failure has been reported. Stop using the product immediately and contact the manufacturer for a refund or repair.
Our severity reasoning: The recall involves a Class II medical device associated with significant injury reports, specifically tissue trauma, perforation, and the need for surgical removal of stuck insertion tubes.
Plain-English summary
Olympus Corporation of the Americas is recalling the URF-P6 and URF-P6R Uretero-reno fiberscopes. The recall involves 3,461 units distributed to US consignees nationwide. All serial numbers are affected.
The recall is being conducted because of adverse event complaints associated with a similar, but not identical, device (URF-V2/V2R endoscopes). These complaints involved tissue trauma, perforation, and insertion tubes that became stuck inside patients and required surgical removal. Olympus is taking this action to mitigate potential risks to patient health.
Users of these devices should carefully inspect the endoscope prior to use in accordance with the instructions provided in the notification letter.
The recalled product
- Product
- URF-P6 Uretero-reno fiberscope and URF-P6R Uretero-reno fiberscope
- Manufacturer
- Olympus Corporation of the Americas
- Category
- Medical Device — Endoscopes
- Affected units
- 3,461
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)
- All serial numbers are affected.
Distribution
Distributed nationwide across the United States.
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
- HighOlympus High Flow Insufflation Unit UHI-4 Recalled Due to Display and Air Delivery Failure
FDA (Devices) · 2026-07-29
- ModerateOlympus 4K UHD LCD Monitors Recalled Due to Potential Connector Faults
FDA (Devices) · 2026-07-29
- HighOlympus Toomey Evacuator 50cc with Adaptor sterilization recall
FDA (Devices) · 2026-07-22
- HighOlympus Toomey Evacuator 30cc medical device sterilization parameters recalled
FDA (Devices) · 2026-07-22
Same hazard · tissue trauma
See all →- HighLaparotomy Sponges recalled for incomplete sterilization and missing RF detection
FDA (Devices) · 2024-03-27
- HighTri-Staple 2.0 Surgical Stapler Reloads Recalled for Malfunction Risk
FDA (Devices) · 2023-03-15
- HighSTRATAFIX Absorbable Sutures Recalled for Wrong Needle Type
FDA (Devices) · 2022-11-09
- SevereRecall of Covidien Signia Stapler Reloads Due to Safety Interlock Failure
FDA (Devices) · 2021-04-21
- SevereFDA Recalls Covidien Signia Stapler Reloads Due to Safety Interlock Failure
FDA (Devices) · 2021-04-21