Recall Z-1009-2024— Olympus Corporation of the Americas

Name: FDA recall Z-1009-2024
Creator: U.S. Food and Drug Administration
Published: 2024-01-16

Class II · Ongoing

Class II FDA medical device recall by Olympus Corporation of the Americas, initiated 2024-01-16. It names one FDA 510(k) clearance: K103264. 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: 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..

Recalling firm: Olympus Corporation of the Americas
Classification: Class II
Status: Ongoing
Initiated: 2024-01-16
Firm location: Center Valley, PA, United States

510(k) clearances named in this recall

1 on FDA's record

K103264 — ENDOSCOPE REPROCESSOR OER-PRO MODEL OER-PROOlympus Medical Systems Corporation·cleared 2011-02-23

K-numbers as listed on FDA's Recall Enterprise System record for this event (openFDA device/recall k_numbers). The recall may also cover devices cleared under other submissions not named here.

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.

Data sourced from openFDA. This site is unofficial and independent of the FDA.