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FDAJanuary 16, 2026device

Olympus High Flow Insufflation Unit. Model Number: UHI-3. Used for insufflation of the abdominal cavity, and automatic suction and smoke evacuation to facilitate laparoscopic observation and treatment within the abdominal cavity.

Official recall recorded by the U.S. Food & Drug Administration.

The hazard

Issue with software algorithm which may lead to overpressure events.

What to do

FDA enforcement status: Ongoing

Brands named

olympus

UPCs

0495317014028004953170140297

Recall history

Other federal recalls tied to the same brand — a factual pattern, straight from the source data.

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Olympus High Flow Insufflation Unit. Model Number: UHI-3. Used for insufflation of the abdominal cavity, and automatic suction and smoke evacuation to facilitate laparoscopic observation and treatment within the abdominal cavity. — Recall Details · AllClear