FDA Medical Device Recalls (openFDA)
Olympus Corporation of the Americas: Olympus URETERO-RENO FIBERSCOPE Model: URF-P6R
- Recall number
- Z-1264-2022
- Recalling firm
- Olympus Corporation of the Americas
- Product
- Olympus URETERO-RENO FIBERSCOPE Model: URF-P6R
- Status
- Open, Classified
- Initiated
- 2022-04-20
- Posted
- not on file
- Terminated
- not on file
- Reason
- 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.
- Root cause
- Nonconforming Material/Component
- Action
- 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.
- Quantity
- 4 units
- Distribution
- CA FL MA MD MI NJ OH PR WI
- Lot, serial or model codes
- UDI-DI: 04953170340833 Serial Number: 2836209F 2835978 2837272 2836299
- 510(k) numbers
- ["K172298"]
- PMA numbers
- not on file
- Product code
- FGB
- Firm FEI
- 2429304
- Firm city
- Center Valley
- Firm state
- PA
- Firm country
- not on file
Where this comes from
- Register
- FDA Medical Device Recalls (openFDA)
- Publisher
- U.S. Food and Drug Administration (openFDA)
- File
- device-recall-0001-of-0001.json.zip
- sha256
- b87518bfe2e8
- Published
- 2026-09-28
- Read
- 2026-09-29T08:25:23.626Z
Unless otherwise noted, the content, data, documentation, code, and related materials on openFDA is public domain and made available with a Creative Commons CC0 1.0 Universal dedication.
Cite as
FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28