Agency classClass IIOur severity:High FDA (Devices)·Z-1263-2022·Announced 2022-06-22

Olympus Uretero-Reno Fiberscope Recalled for Defective Adhesive and Vision Loss

The Olympus URETERO-RENO FIBERSCOPE Model URF-P6 is recalled for incorrect adhesive securing the diopter ring. The defect may cause loss of adjustment function, blurred vision, and in rare cases, urinary tract perforation.

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 device with potential for serious injury (urinary tract perforation) but no reported illnesses or injuries. The hazard is characterized as occurring in rare cases, making it a risk-of-harm product where injury has not yet been reported.

Plain-English summary

The Olympus URETERO-RENO FIBERSCOPE Model URF-P6 is being recalled due to incorrect adhesive used to secure the diopter ring and nameplate ring. An improperly connected diopter ring can result in loss of the adjustment function.

When adjustment function is lost, the device may exhibit a blurred field of vision. This can lead to unintended contact between the scope and the patient's body. In rare cases, this may result in perforation of the urinary tract or renal pelvis.

Two units have been identified and are distributed across California, Florida, Massachusetts, Maryland, Michigan, New Jersey, Ohio, Puerto Rico, and Wisconsin.

The recalled product

Product: Olympus URETERO-RENO FIBERSCOPE Model: URF-P6
Manufacturer: Olympus Corporation of the Americas
Category: Medical Device — Urological Endoscope
Hazard: adhesive-defect
vision-impairment
unintended-contact
perforation-risk
Affected units: 2

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)

UDI-DI: 04953170340802 Serial Number: 2836210 2834747I

Distribution

Distributed in 9 states:

Part of a larger recall action

This product is one of 3 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.

See all 3 products in this recall →

Same manufacturer · Olympus Corporation of the Americas

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