Olympus Corporation of the Americas recalls OER-Pro Endoscope Reprocessor, Endoscope washer/disinfector

Recall date

June 23, 2016

Source

U.S. Food & Drug Administration (FDA) — enforcement report

Recall number

Z-0138-2017

FDA classification

Class II

Brand / firm

Olympus Corporation of the Americas

Sold / distributed

Distributed to: AK,AL,AR,AZ,CA,CO,CT,DC,DE,FL,GA,HI,IA,ID,IL,IN,KS,KY,LA,MA,MD,ME,MI,MN,MO,MS,MT,NC,ND,NE,NH,NJ,NM,NV,NY,OH,OK,OR,PA,RI,SC,TN,TX,UT,VA,VT,WA,WI,WV,WY

Why it was recalled

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.

Class II means using this product may cause temporary or medically reversible health problems; the chance of serious harm is remote.

What was recalled

OER-Pro Endoscope Reprocessor, Endoscope washer/disinfector