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Recall Observatory FDA recall evidence

Device product

OER-Pro Endoscope Reprocessor, Endoscope washer/disinfector

Z-0138-2017

June 23, 2016

Class II

Product summary

Firm
Olympus Corporation of the Americas
Event
Event 74542
Status
Terminated
Classification
Class II
Quantity
2, 686 units
Official record key
device-enforcement:Z-0138-2017

Official wording

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.

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

Derived failure modes

  • Unknown

    reason.no_named_rule · v1.0.0

    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.