Recall Z-0138-2017— Olympus Corporation of the Americas

Name: FDA recall Z-0138-2017
Creator: U.S. Food and Drug Administration
Published: 2016-06-23

Class II · Terminated

Class II FDA medical device recall by Olympus Corporation of the Americas, initiated 2016-06-23, terminated 2017-01-26. It names one FDA 510(k) clearance: K103264. Product: OER-Pro Endoscope Reprocessor, Endoscope washer/disinfector. Reason: New warning requiring Users to conduct duodenoscope precleaning and manual cleaning even when using an Automated Endoscope Reprocessor (AER) that has instructions that may indicate a user could forego certain steps in precleaning and manual cleaning of the endoscopes..

Recalling firm: Olympus Corporation of the Americas
Classification: Class II
Status: Terminated
Initiated: 2016-06-23
Terminated: 2017-01-26
Firm location: Center Valley, PA, United States

510(k) clearances named in this recall

1 on FDA's record

K103264 — ENDOSCOPE REPROCESSOR OER-PRO MODEL OER-PROOlympus Medical Systems Corporation·cleared 2011-02-23

K-numbers as listed on FDA's Recall Enterprise System record for this event (openFDA device/recall k_numbers). The recall may also cover devices cleared under other submissions not named here.

Product description

OER-Pro Endoscope Reprocessor, Endoscope washer/disinfector

Reason for recall

New warning requiring Users to conduct duodenoscope precleaning and manual cleaning even when using an Automated Endoscope Reprocessor (AER) that has instructions that may indicate a user could forego certain steps in precleaning and manual cleaning of the endoscopes.

Data sourced from openFDA. This site is unofficial and independent of the FDA.