Olympus Uretero-reno Fiberscope Recalled for Insertion Tube Breakage
Olympus is recalling 2,399 Uretero-reno fiberscopes 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 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 is classified as FDA Class II and involves a structural defect in a medical device used during surgery, which meets the criteria for a Severe rating due to the potential for significant injury.
Plain-English summary
Olympus Corporation of the Americas is recalling 2,399 units of the Uretero-reno fiberscope URF-P6RP6. The recall covers all serial numbers of this specific model. The devices were distributed nationwide in the United States, as well as in Canada and Mexico.
The recall was issued because the insertion tube bending section of the endoscope may break during surgical procedures. This defect poses a risk of harm to patients if the device fails while in use.
Healthcare facilities and consumers should stop using the affected devices immediately. Olympus is the firm responsible for the recall and is handling the corrective actions.
The recalled product
- Product
- Uretero-reno fiberscope URF-P6RP6
- Manufacturer
- Olympus Corporation of the Americas
- Category
- Medical Device — Endoscope
- Affected units
- 2,399
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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