FDA recall Z-1009-2024

Olympus Corporation of the Americas · Class II · device

Product

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.

Distribution

Domestic US distribution nationwide.

Key facts

Status
Ongoing
Initiation date
2024-01-16
Report date
2024-02-14
Voluntary/Mandated
Voluntary: Firm initiated
Location
Center Valley, PA, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1009-2024