Olympus Uretero-reno Fiberscope URF-P6 Recalled for Insertion Tube Breakage
Olympus is recalling 1,062 Uretero-reno fiberscopes URF-P6 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 structural defect in a medical device used during surgery that poses a risk of harm, but the source text does not report any specific injuries or illnesses, fitting the criteria for a High severity score.
Plain-English summary
Olympus Corporation of the Americas is recalling 1,062 units of the Uretero-reno fiberscope URF-P6. The recall was initiated because the insertion tube bending section of the endoscope may break during surgical procedures.
The affected devices were distributed in the United States, Canada, and Mexico. The recall includes all serial numbers of the URF-P6 model.
Healthcare facilities should stop using the affected devices and contact Olympus for instructions on how to return them.
The recalled product
- Product
- Uretero-reno fiberscope URF-P6
- Manufacturer
- Olympus Corporation of the Americas
- Category
- Medical Device — Endoscope
- Hazard
- Affected units
- 1,062
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.
Part of a larger recall action
This product is one of 2 recalled by Olympus Corporation of the Americas under a single FDA (Devices) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.
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