Z-0138-2017Class II

OER-Pro Endoscope Reprocessor, Endoscope washer/disinfector

Name: Z-0138-2017 OER-Pro Endoscope Reprocessor, Endoscope washer/disinfector
Creator: Olympus Corporation of the Americas
Published: 2016-06-23
License: https://open.fda.gov/license/

OLYMPUS Corporation of the Americas / initiated 2016-06-23 / Terminated

FDA source

Olympus Corporation of the Americas began a recall of OER-Pro Endoscope Reprocessor, Endoscope washer/disinfector on 2016-06-23. FDA classified it as Class II and gives the reason as "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...". As of 2026-09-10, the recall status on record is Terminated.

Recall record

Recall number: Z-0138-2017
Classification: Class II
Status: Terminated
Initiated: 2016-06-23
Posted: 2016-10-19
Terminated: 2017-01-26
Recalling firm: OLYMPUS Corporation of the Americas
Product: OER-Pro Endoscope Reprocessor, Endoscope washer/disinfector
Product code: FEB Accessories, Cleaning, For Endoscope
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.
FDA root cause: Under Investigation by firm
Action: Olympus America Inc. (OAI) mailed a letter to customers informing them that they are issuing an updated Operation Manual for the OER-Pro Automated Endoscope Reprocessor. The following actions were asked to be taken: -Olympus has discontinued previously distributed copies of the OER-Pro Operation Manual. - Inspect your inventory of Operation Manuals and discard any existing inventory of OER-Pro Operation Manuals. - Implement use of the enclosed OER-Pro Operation Manual, which contains the new Warning on pages 73 and 80. - Ensure all reprocessing personnel are completely knowledgeable and thoroughly trained on the requirement to perform precleaning and manual cleaning of Olympus duodenoscopes prior to placing the duodenoscopes in the OER-Pro for high level disinfection. - Additional copies of the new OER-Pro Operation Manual can be obtained by contacting our Technical Assistance Center at 1-800-848-9024, option 1, or by indicating on the enclosed questionnaire. Additional Operation Manuals will be mailed to your facility - Please indicate on the enclosed questionnaire that you have received this notification. Fax the completed form to (484) 896-7128.
Quantity in commerce: 2, 686 units
Distribution: 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
Product codes and lots: Model: OER-Pro, All serial numbers affected

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-0138-2017
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-0138-2017	Class II	Terminated	Voluntary: Firm initiated	2016-10-26	2016-10-19

Product code FEB

K103264Class IIEndoscope Reprocessor Oer-Pro Model Oer-ProOlympus Medical Systems Corporation / cleared 2011-02-23

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-10-14, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)