URF-P6 Uretero-reno fiberscope and URF-P6R Uretero-reno fiberscope — Class II medical device recall Z-1251-2017
Terminated recall by Olympus Corporation of the Americas, reported 2017-03-08, distributed nationwide. Olympus is recalling the URF-P6/P6R endoscopes due to a similar device (URF-V2/V2R endoscopes) but not identic
| Recall number | Z-1251-2017 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Olympus Corporation of the Americas, Center Valley, PA, United States |
| Recall initiated | 2016-12-12 |
| Classified | 2017-02-24 |
| Reported by FDA | 2017-03-08 |
| Terminated | 2018-02-26 |
| Distributed | Nationwide (US) |
| Quantity | 3,461 units |
Product
URF-P6 Uretero-reno fiberscope and URF-P6R Uretero-reno fiberscope
Reason for recall
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.
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/Z-1251-2017. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.