The Recall Desk
HighFDA (Devices)·Z-1116-2022·Announced 2022-05-25

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.

What this means for you

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
Hazard
  • cracking
  • device-malfunction
  • structural-defect

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

Distributed nationwide across the United States.

Related recalls

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