Reported Oct 26, 2016 · Terminated
OER-Pro Endoscope Reprocessor, Endoscope washer/disinfector
Olympus Corporation of the Americas
Moderate riskThis product could cause temporary or reversible health problems — stop using it.What you should do
Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.
Firm contact: Olympus Corporation of the Americas · 3500 Corporate Pkwy · Center Valley, PA · 18034-0610
Is this the product you have?
- OER-Pro Endoscope Reprocessor, Endoscope washer/disinfector
- Lot codes and dates
- ModelOER-Pro, All serial numbers affected
- Amount recalled
- 2, 686 units
Where it was sold
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.
This product could cause temporary or reversible health problems — stop using it.
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