FDAClass IIJune 22, 2022

Olympus Uretero-reno Fiberscope recall

Olympus URETERO-RENO FIBERSCOPE Model: URF-P6R

Why was Olympus Uretero-reno Fiberscope recalled?

Incorrect adhesive used to secure the diopter ring and nameplate ring. Improperly connected diopter ring may result in the loss of adjustment function leading to a blurred field of vision and unintentional contact with the patients body and in rare cases perforation in the urinary tract/renal pelvis.

What should I do if I have this product?

The recall is ongoing. Follow the firm and FDA instructions.

What to do with a recalled product: refunds, receipts, safe disposal and how to report a problem.

Is my product affected?

Compare the item in your hand with every identifier below from the official FDA record. Only products that match the listed product and lot, UPC or model codes are part of this recall.

Which lot codes, UPCs or models are affected?

UDI-DI: 04953170340833 Serial Number: 2836209F 2835978 2837272 2836299

Product
Olympus URETERO-RENO FIBERSCOPE Model: URF-P6R
Recalling firm
Olympus Corporation of the Americas
Quantity
4 units
Distribution
CA FL MA MD MI NJ OH PR WI
Recall date
June 22, 2022
Classification
Class II
Status
Ongoing
Agency
FDA (device)
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