Olympus Corporation of the Americas: Medical Device Recall in 2016 - (Recall #: Z-0138-2017)

Updated on March 25, 2026.

See the recall detail below. You can also see other recalls from the same firm in 2016.

Data Source: FDA.

Product Description:

OER-Pro Endoscope Reprocessor, Endoscope washer/disinfector

Product Classification:

Class II

Date Initiated: June 23, 2016

Date Posted: October 26, 2016

Recall Number: Z-0138-2017

Event ID: 74542

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.

Status: Terminated

Product Quantity: 2, 686 units

Code Information:

Model: OER-Pro, All serial numbers affected

Distribution Pattern:

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

Voluntary or Mandated:

Voluntary: Firm initiated