Olympus Uretero-reno Videoscope Recall Due to Insertion Tube Breakage
Olympus is recalling URF-V2 and URF-V2R endoscopes because the insertion tube bending section may break during surgery, causing tissue trauma.
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 with reports of significant injury, including tissue trauma, perforation, and the need for surgical removal of broken parts.
Plain-English summary
Olympus Corporation of the Americas is recalling 1,627 units of Uretero-reno videoscope URF-V2 and URF-V2R endoscopes and accessories. These devices are intended for endoscopic diagnosis and treatment within the ureter and kidney. The recall covers units distributed in the United States and Canada.
The recall was initiated after Olympus received complaints regarding the breakage of the endoscope's insertion tube bending section during surgical procedures. Some of these incidents were associated with tissue trauma, including perforation. In some cases, the insertion tubes became stuck inside the patient and required surgical removal.
Healthcare providers should stop using these devices and contact Olympus for further instructions. Consumers who have had these devices used on them should consult their healthcare provider.
The recalled product
- Product
- Uretero-reno videoscope URF-V2 and URF-V2R endoscope and accessories The URF-V2/V2R endoscopes are intended for use in endoscopic diagnosis and treatment within the ureter and kidney.
- Manufacturer
- Olympus Corporation of the Americas
- Category
- Medical Device — Endoscope
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
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
- SevereOlympus BiCOAG Hemostasis Probe Recall Due to Ceramic Tip Detachment Risk
FDA (Devices) · 2026-09-30
- HighOlympus BiCOAG Hemostasis Probe Recalled for Potential Ceramic Tip Detachment
FDA (Devices) · 2026-09-30
Same hazard · device breakage
See all →- HighTissium Peripheral Nerve Repair Device Shelf Life Recall
FDA (Devices) · 2026-08-12
- HighPeripheral Nerve Repair Device Relabeled Due to Unsubstantiated Shelf Life
FDA (Devices) · 2026-08-12
- HighTissium COAPTIUM CONNECT Nerve Repair Device Shelf Life Recall
FDA (Devices) · 2026-08-12
- HighSurgify Halo Surgical Burr Breakage Risk During Spinal Surgery
FDA (Devices) · 2026-07-01
- SevereSurgify Halo 4.0mm Extendable Surgical Burr Recall for Breakage Risk
FDA (Devices) · 2026-07-01
Similar recalls
- HighOlympus Uretero-reno Videoscope Recalled for Potential Insertion Tube Breakage
FDA (Devices) · 2018-08-01
- SevereOlympus Recalls URF-P6 Uretero-reno Fiberscopes Due to Tissue Trauma Risk
FDA (Devices) · 2017-03-08
- 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
- HighOlympus Uretero-reno Videoscope Bending Section May Crack and Deform
FDA (Devices) · 2022-05-25
- HighUretero-reno fiberscopes recalled due to inadequate channel drying
FDA (Devices) · 2023-11-29