Class II

Medical Device Recall: 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

Olympus Corporation of the Americas · January 16, 2024

Reason for Recall

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.

Product Description

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.

Distribution

Domestic US distribution nationwide.

States Affected

NATIONWIDE

Quantity Affected

877 MAJ-2318, 119 OER-Elite, 3 OER-MINI

Source: FDA (openFDA Device Enforcement)

Recall number: Z-1009-2024

Status: ongoing

SafeCheck provides drug interaction information from FDA-approved product labeling (openFDA). This is for informational purposes only and is not medical advice. Always consult your healthcare provider before making medication decisions.