FDADecember 12, 2016device

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

Official recall recorded by the U.S. Food & Drug Administration.

The hazard

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.

What to do

FDA enforcement status: Terminated

Brands named

olympus

Recall history

Other federal recalls tied to the same brand — a factual pattern, straight from the source data.

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