Class I

Medical Device Recall: 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 trea

Olympus Corporation of the Americas · January 16, 2026

Reason for Recall

Issue with software algorithm which may lead to overpressure events.

Product Description

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.

Distribution

Nationwide distribution

States Affected

NATIONWIDE

Quantity Affected

744 units

Source: FDA (openFDA Device Enforcement)

Recall number: Z-1353-2026

Status: ongoing

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