Olympus recalls URF-P6 ureterorenal fiberscopes due to adhesive issues causing blurred vision and rare urinary tract perforation. Affected units have specific serial numbers.
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.
Olympus is recalling URF-P6 ureterorenal fiberscopes because faulty adhesive might cause blurred vision and, in rare cases, urinary tract perforation. This affects medical devices used during procedures.
The fiberscope's diopter ring and nameplate ring are secured with incorrect adhesive. This can cause the rings to become improperly connected, leading to loss of adjustment function. As a result, the device may produce blurred vision and cause unintended contact with the patient's body, potentially perforating the urinary tract or renal pelvis in rare cases.
Medical professionals using Olympus URF-P6 fiberscopes for urological procedures are most at risk. Patients undergoing these procedures could experience complications if the device malfunctions.
Check for the model number URF-P6 on the device. Affected units have serial numbers 2836210 or 2834747I. The device may have a UDI-DI code starting with 04953170340802.
Look for serial numbers 2836210 or 2834747I on the device.
The recall is for potential blurred vision and rare urinary tract perforation, but the risk is low as it only occurs in specific cases.
Check for the model URF-P6 and serial numbers 2836210 or 2834747I. The UDI-DI code starts with 04953170340802.
The recall does not specify a remedy, so contact Olympus directly for guidance.
We’ve drafted a message you can send Olympus to request your refund or repair — edit it as you like.
Subject: Recall Z-1263-2022 — Olympus Olympus Hello, I own a Olympus that is covered by recall Z-1263-2022 from Olympus. I’m writing to arrange the remedy described in the recall (a refund, repair, or replacement as applicable). Could you please tell me the next steps to resolve this? Thank you.
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The facts (hazard, remedy, dates, manufacturer) are pulled from the official FDA recall record. The plain-language summary and step-by-step checklist are written by GovInfoNow to make the official notice easier to act on — they don’t replace it.