Olympus Uretero-reno Videoscope Recalled for Potential Insertion Tube Breakage
Olympus is recalling 2,548 Uretero-reno videoscopes because the insertion tube bending section may break during surgery.
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: The recall involves a risk-of-harm product (medical device) where injury has not yet been reported, fitting the High severity criteria.
Plain-English summary
Olympus Corporation of the Americas is recalling 2,548 units of the Uretero-reno videoscope URF-V2 and URF-V2R. The recall was initiated because the insertion tube bending section of the endoscope has the potential to break during surgical procedures.
The affected devices were distributed nationwide in the United States and in Canada. The recall includes all serial numbers for these specific models.
Healthcare providers should stop using the affected devices and contact Olympus Corporation of the Americas for instructions on how to return or replace them.
The recalled product
- Product
- Uretero-reno videoscope URF-V2 Uretero-reno videoscope URF-V2R
- Manufacturer
- Olympus Corporation of the Americas
- Category
- Medical Device — Endoscope
- Hazard
- Affected units
- 2,548
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.
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