Olympus Corporation of the Americas: Medical Device Recall in 2017 - (Recall #: Z-1251-2017)

Updated on March 25, 2026.

See the recall detail below. You can also see other recalls from the same firm in 2017.

Data Source: FDA.

Product Description:

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

Product Classification:

Class II

Date Initiated: December 12, 2016

Date Posted: March 8, 2017

Recall Number: Z-1251-2017

Event ID: 75990

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.

Status: Terminated

Product Quantity: 3461 units distributed to US consignees

Code Information:

All serial numbers are affected.

Distribution Pattern:

Distributed Nationwide

Voluntary or Mandated:

Voluntary: Firm initiated