FDA Medical Device Recalls (openFDA)
Olympus Corporation of the Americas: Uretero-reno fiberscope URF-P6RP6
- Recall number
- Z-2520-2018
- Recalling firm
- Olympus Corporation of the Americas
- Product
- Uretero-reno fiberscope URF-P6RP6
- Status
- Terminated
- Initiated
- 2018-01-17
- Posted
- not on file
- Terminated
- 2019-12-04
- Reason
- Breakage of the endoscope's insertion tube bending section during surgical procedures.
- Root cause
- Device Design
- Action
- On 1/17/18 an Urgent Medical Device Removal Action Notification letter was shipped to affected customer via Fed-EX. The notification informed customers the recall was initiated in response to customer complaints regarding the breakage of the endoscopes insertion tube bending section during surgical procedures.Customers were instructed to complete the following: 1. Inspect your inventory and identify any URF-P6/P6R models; 2.Olympus will contact your facility to make arrangements for return of your URF-P6/P6R fiberscope(s) for the device exchange. You will be provided instructions on returning the URF-P6/P6R for this exchange; 3.Olympus has discontinued previously distributed copies of the URF-P6/P6R Reprocessing Manual and the Operation Manual Inspect your inventory of the Reprocessing Manual and the Operation Manual, and discard any existing inventory of the URF-P6/P6R Reprocessing Manual and the Operation Manual; 4.Implement use of the enclosed Reprocessing Manual which recommends only sterilization methods, and the enclosed Operation Manual; 5. Ensure all reprocessing personnel are completely knowledgeable and thoroughly trained on the new reprocessing instructions in the new Reprocessing Manual; 6. If you may have further distributed the URF-P6/P6R, please identify your customers, notify them at once of this product recall, and appropriately document your notification process. Your notification to your customers may be enhanced by including a copy of this recall notification letter; 7. Please indicate on the enclosed questionnaire that you have received this notification. Return of the enclosed questionnaire will be deemed to be a request for a new replacement URF-P6/P6R fiberscope(s). Fax the completed form to 484-896-7128.
- Quantity
- 2399
- Distribution
- US Nationwide. Canada and Mexico
- Lot, serial or model codes
- All serial numbers
- 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
- Size
- 288210821 bytes
- Published
- 2026-09-28
- Read
- 2026-09-29T08:25:23.626Z
- Source file
- Source file retained · verify
- Refresh due
- 2026-10-06
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