FDADecember 13, 2021device

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

Official recall recorded by the U.S. Food & Drug Administration.

The hazard

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

What to do

FDA enforcement status: Terminated

Brands named

olympus

UPCs

04953170404047

Recall history

Other federal recalls tied to the same brand — a factual pattern, straight from the source data.

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