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.
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