Olympus Uretero-reno Videoscope Bending Section May Crack and Deform
The bending section of the Olympus URF-V2 videoscope may crack and develop abnormal shape or angulation. This could affect the device's function during urological procedures.
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 3/5 (High).
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 medical device with a structural defect (cracking bending section) that represents a risk of harm during procedures. No illnesses or injuries have been reported, placing this under the rubric criterion for risk-of-harm products where injury has not yet been reported.
Plain-English summary
Olympus Corporation of the Americas is recalling the Olympus Uretero-reno videoscope, Model No. URF-V2 (serial number 2825505F). The bending section of this medical device may crack, potentially resulting in abnormal shape or abnormal angulation.
A cracked or deformed bending section could compromise the device's ability to function properly during urological procedures. The affected device was distributed in the United States.
Consumers who have this device should contact Olympus Corporation of the Americas for instructions on its return or replacement. Do not use the device if the bending section shows signs of damage or deformation.
The recalled product
- Product
- Olympus Uretero-reno videoscope, Model No. URF-V2
- Manufacturer
- Olympus Corporation of the Americas
- Category
- Medical Device — Endoscope
- Affected units
- 1
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 (2)
- 1 unit
- serial number 2825505F UDI 04953170343582
Distribution
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