Recall Z-1375-2024— Olympus Corporation of the Americas

Name: FDA recall Z-1375-2024
Creator: U.S. Food and Drug Administration
Published: 2023-09-25

Class II · Ongoing

Class II FDA medical device recall by Olympus Corporation of the Americas, initiated 2023-09-25. It names one FDA 510(k) clearance: K110294. Product: Insufflation unit, UHI-4.. Reason: Olympus has become aware of an increased trend of both repairs and customer complaints reporting "UHI-4 stopping air supply due to the front panel LED turning off"..

Recalling firm: Olympus Corporation of the Americas
Classification: Class II
Status: Ongoing
Initiated: 2023-09-25
Firm location: Center Valley, PA, United States

510(k) clearances named in this recall

1 on FDA's record

K110294 — HIGH FLOW INSUFFLATION UNIT UHI-4Olympus Medical Systems Corporation·cleared 2011-11-18

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

Insufflation unit, UHI-4.

Reason for recall

Olympus has become aware of an increased trend of both repairs and customer complaints reporting "UHI-4 stopping air supply due to the front panel LED turning off".

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