Recall Z-0873-2026— Aizu Olympus Co., Ltd.

Name: FDA recall Z-0873-2026
Creator: U.S. Food and Drug Administration
Published: 2025-10-31

Class II · Ongoing

Class II FDA medical device recall by Aizu Olympus Co., Ltd., initiated 2025-10-31. It names one FDA 510(k) clearance: K103264. Product: Olympus OER-Pro. Reason: Inform existing affected device customers about pertinent Warnings/Cautions, existing recommended maintenance schedules and that only properly trained personnel conduct repairs and maintenance..

Recalling firm: Aizu Olympus Co., Ltd.
Classification: Class II
Status: Ongoing
Initiated: 2025-10-31
Firm location: Aizuwakamatsu, Japan

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

Olympus OER-Pro

Reason for recall

Inform existing affected device customers about pertinent Warnings/Cautions, existing recommended maintenance schedules and that only properly trained personnel conduct repairs and maintenance.

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