Olympus Corporation of the Americas Olympus URETERO-RENO FIBERSCOPE Model: URF-P6 Recall
Check Your Product
According to the U.S. Food and Drug Administration (FDA)
Product
Olympus URETERO-RENO FIBERSCOPE Model: URF-P6
Brand
Olympus Corporation of the Americas
Lot Codes / Batch Numbers
UDI-DI: 04953170340802 Serial Number: 2836210 2834747I
Products Sold
UDI-DI: 04953170340802 Serial Number: 2836210 2834747I
Olympus Corporation of the Americas is recalling Olympus URETERO-RENO FIBERSCOPE Model: URF-P6 due to Incorrect adhesive used to secure the diopter ring and nameplate ring. Improperly connected diopter ring may result in the loss of adjustment function. Based on FDA medical device recall database.
Summary derived from FDA notice
Reason for Recall
As stated by FDA
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.
Recommended Action
Per FDA guidance
Olympus notified Urgent Medical Device Correction letter on 4/20/22 via email. Letter states reason for recall, health risk and action to take: 1. Identify the affected model and serial number in the subject of this letter. The model and serial number can be found on the device as illustrated. 2. An Olympus representative will contact you to make arrangements for return of your affected device. Olympus will repair your unit free of charge. In the meantime, follow the instruction manual for inspection of the device before use. Should any irregularities be identified, including a loose parts, do not use the device and contact Olympus for repair. 3. Olympus will arrange for a service loaner in an effort not to disrupt clinical care. Contact me directly at 647-999-3203 or at Cynthia.Ow@Olympus.com for any additional information or support concerning this matter.
Verify this information on the official source
For complete details and official instructions, check the U.S. Food and Drug Administration (FDA) directly.
View official FDA recall noticeDistribution
As reported by FDA
CA, FL, MD, MA, MI, NJ, OH, WI, PR
Page updated: Jan 10, 2026