FDA Device recall Z-1251-2017
URF-P6 Uretero-reno fiberscope and URF-P6R Uretero-reno fiberscope
- FDA Device
- Class II
- terminated
- Published 2017-03-08
On 2017-03-08 the FDA classified a Class II recall of URF-P6 Uretero-reno fiberscope and URF-P6R Uretero-reno fiberscope by Olympus, citing olympus is recalling the URF-P6/P6R endoscopes due to a similar device (URF-V2/V2R endoscopes) but not identical, where adverse event complaints associated with tissue trauma, per….
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-1251-2017 |
| Classification | Class II |
| Status | terminated |
| Initiated | 2016-12-12 |
| Published | 2017-03-08 |
| Last updated | 2026-09-13 11:54 UTC |
| Company | Olympus |
| Distribution | US |
Product
URF-P6 Uretero-reno fiberscope and URF-P6R Uretero-reno fiberscope
Reason
Olympus is recalling the URF-P6/P6R endoscopes due to a similar device (URF-V2/V2R endoscopes) but not identical, where adverse event complaints associated with tissue trauma, perforation and insertion tubes which were stuck inside of patients that had to be surgically removed. In an effort to mitigate a potential risk to patient health, Olympus is undertaking this action to notify users of these complaints and the need for careful inspection of the endoscope prior to use in accordance with the instructions provided int heir notification letter.
Identifiers
| code_info | All serial numbers are affected. |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:54 UTC. Current status: terminated.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-1251-2017%22
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