medical Class II Updated 2022-02-23

Olympus Corporation of the Americas recalls OER-Elite Endoscope Reprocessor-for use in cleaning and high

Recalled Product

OER-Elite Endoscope Reprocessor-for use in cleaning and high-level disinfection of heat sensitive Olympus flexible endoscopes, their accessories, and endoscope reprocessor accessories


Hazard / Issue

The detergent and alcohol tank tubing may have been incorrectly assembled in the OER-Elite. If the tubing is incorrectly assembled, alcohol will be dispensed instead of detergent for the cleaning cycle and detergent will be dispensed instead of alcohol for the alcohol cycle, resulting in a ineffective endoscope reprocessing and patient exposure to residual detergent

Issued by

FDA

Distribution: Nationwide (United States)
Lot/Code Info: All serial numbers. UDI: 04953170404047
View official government recall

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