Olympus Corporation of the Americas recalls Olympus High Flow Insufflation Unit. Model/ Number: UHI-2. Used for insufflation of the abdominal cavity, and automatic…

Recall date

January 16, 2026

Source

U.S. Food & Drug Administration (FDA) — enforcement report

Recall number

Z-1353-2026

FDA classification

Class I

Brand / firm

Olympus Corporation of the Americas

Sold / distributed

Nationwide distribution

Why it was recalled

Issue with software algorithm which may lead to overpressure events.

Class I is the FDA’s most serious recall level: there is a reasonable probability that using this product will cause serious harm or death.

What was recalled

Olympus High Flow Insufflation Unit. Model/ Number: UHI-2. Used for insufflation of the abdominal cavity, and automatic suction and smoke evacuation to facilitate laparoscopic observation and treatment within the abdominal cavity.