URF-P6 Uretero-reno fiberscope and URF-P6R Uretero-reno fiberscope

Recall Insight

This FDA Devices action (record #Z-1251-2017) was formally reported on March 8, 2017, with the manufacturer initiating the action on December 12, 2016. It is classified under Moderate severity (Class II), with a current status of Terminated. Olympus Corporation of the Americas is listed as the recalling firm, operating out of Center Valley, PA. Federal records indicate 3461 units distributed to US consignees units are affected.

The documented reason for this recall is: 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 … Distribution data in the federal record shows the product reached: Distributed Nationwide. Distribution scope directly affects the consumer exposure window and determines whether a recall remains regional or escalates into a nationwide advisory.

To put this record in context, PlainRecalls indexes 83,949 recalls across the FDA, CPSC, NHTSA and USDA FSIS going back to 1995. Within the same product category, the database holds 6 closely related recalls, of which 6 were also issued by FDA Devices. That clustering is a signal — repeated actions in a narrow category often indicate a systemic quality-control issue, a supplier-wide contamination, or a design defect that has propagated across product lines. This recall is roughly 9 years old; older recalls can remain relevant because many units enter resale, rental, and secondary-market channels where the original warning never reaches the end user. Always cross-check the recall number against the official agency page before relying on any summary.