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.
The agency’s classification
FDA (Devices): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 4/5 (Severe).
The hazard poses a serious risk of illness, injury, or structural failure. 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 M3 Gold Autoclavable Foroblique Telescope Recalled for Sterilization Labeling Discrepancy
FDA (Devices) · 2026-10-07
- ModerateOlympus DisplayPort Cable Recalled for Video Dropout Risk
FDA (Devices) · 2026-10-07
- ModerateOlympus M3 Gold Autoclavable Lateral Telescope 70 Recalled for Sterilization Labeling Discrepancies
FDA (Devices) · 2026-10-07
- ModerateOlympus Endoscopic Balloon Dilator Recalled for Incorrect Inflation Chart Label
FDA (Devices) · 2026-09-30
- SevereOlympus BiCOAG Hemostasis Probe Recall Due to Ceramic Tip Detachment Risk
FDA (Devices) · 2026-09-30
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
Similar recalls
- SevereOlympus Uretero-reno Fiberscope Recalled for Insertion Tube Breakage
FDA (Devices) · 2018-08-01
- HighOlympus Uretero-reno Fiberscope URF-P6 Recalled for Insertion Tube Breakage
FDA (Devices) · 2018-08-01
- SevereOlympus Uretero-reno Videoscope Recall Due to Insertion Tube Breakage
FDA (Devices) · 2017-03-08
- HighOlympus Uretero-reno Videoscope Recalled for Potential Insertion Tube Breakage
FDA (Devices) · 2018-08-01
- HighOlympus Fiberscope Recalled for Defective Diopter Ring Adhesive
FDA (Devices) · 2022-06-22
- HighOlympus Tracheal Intubation Fiberscope Recalled Due to Lodging Risk
FDA (Devices) · 2023-09-06