Recall
FDAHealthJanuary 16, 2026

Olympus Corporation of the Americas — Olympus High Flow Insufflation Unit. Model Number: UHI. Used for insufflation of the abdominal cavity, and automatic suction and smoke evacuation to facilitat

⚠️ Issue with software algorithm which may lead to overpressure events.

Is this relevant to me?

Geography
Nationwide
Source agency
FDA
Category
Health
Published
January 16, 2026

Nationwide distribution

What's affected?

Product
Olympus High Flow Insufflation Unit. Model Number: UHI. Used for insufflation of the abdominal cavity, and automatic suction and smoke evacuation to facilitate laparoscopic observation and treatment within the abdominal cavity.
Lot code
Model Number: UHI; UDI-DI: N/A; All Serial Numbers

Additional details

Model Number: UHI; UDI-DI: N/A; All Serial Numbers

What should I do?

Recommended action

Class I recall. Voluntary: Firm initiated Quantity affected: 18 units.

View original FDA notice →

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