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FDAJanuary 16, 2024device

Water Filter MAJ-2318. This MAJ-2318 water filter has been designed to be used with Olympus endoscope reprocessor for prevent contamination of the rinse water. The MAJ-2318 water filter is compatible with OER-ELITE and OER-MINI.

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

The hazard

Water filter may have been assembled incorrectly, resulting in unfiltered tap water being used for reprocessing. This may expose a patient to a potentially contaminated device, presenting a risk of infection or sepsis.

What to do

FDA enforcement status: Ongoing

Brands named

olympus

UPCs

04953170401473

Recall history

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

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