Recall Z-2776-2026— Olympus Corporation of the Americas

Name: FDA recall Z-2776-2026
Creator: U.S. Food and Drug Administration
Published: 2026-06-16

Class II · Ongoing

Class II FDA medical device recall by Olympus Corporation of the Americas, initiated 2026-06-16. It names one FDA 510(k) clearance: K243527. Product: Olympus High Flow Insufflation Unit - UHI-4. Model Number: UHI-4. Reason: Potential for unexpected instances where the front panel display turns off unexpectedly, and air delivery (insufflation) ceases..

Recalling firm: Olympus Corporation of the Americas
Classification: Class II
Status: Ongoing
Initiated: 2026-06-16
Firm location: Center Valley, PA, United States

510(k) clearances named in this recall

1 on FDA's record

K243527 — High Flow Insufflation Unit (UHI-4)Olympus Medical Systems Corporation·cleared 2025-01-13

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 High Flow Insufflation Unit - UHI-4. Model Number: UHI-4

Reason for recall

Potential for unexpected instances where the front panel display turns off unexpectedly, and air delivery (insufflation) ceases.

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