PlainRecalls
FDA Devices Moderate Class II Ongoing

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.

Reported: February 14, 2024 Initiated: January 16, 2024 #Z-1009-2024

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.

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.

Details

Units Affected
877 MAJ-2318, 119 OER-Elite, 3 OER-MINI
Distribution
Domestic US distribution nationwide.
Location
Center Valley, PA

Frequently Asked Questions

What product was recalled?
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.. Recalled by Olympus Corporation of the Americas. Units affected: 877 MAJ-2318, 119 OER-Elite, 3 OER-MINI.
Why was this product recalled?
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.
Which agency issued this recall?
This recall was issued by the FDA Devices on February 14, 2024. Severity: Moderate. Recall number: Z-1009-2024.