WhichRecall
Class I — UrgentReported 2026-02-25

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.

Recalled by Olympus Corporation of the Americas

Reason for Recall

Issue with software algorithm which may lead to overpressure events.

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Recall Number
Z-1354-2026
Classification
Class I
Status
Ongoing
Category
device
Initiated
2026-01-16
Reported
2026-02-25
Distribution
Nationwide distribution
Code Info
Model Number: UHI-3; UDI-DI: 04953170140280, 04953170140297; All Serial Numbers.
Source: openFDA enforcement report. WhichRecall is not affiliated with the FDA. See our disclaimer.
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