Olympus High Flow Insufflation Unit. Model Number: UHI-3. Used for insufflation of the abdominal
Pending LLM rewrite. Source: FDA_DEVICE Z-1354-2026.
Severity not yet assessed
We have not scored this recall against our rubric yet, so we are not showing a severity rating or our usual guidance. The agency’s own notice below is the authoritative source — read it first.
Plain-English summary
Issue with software algorithm which may lead to overpressure events.
The recalled product
- Product
- 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.
- Manufacturer
- Olympus Corporation of the Americas
- Category
- Medical Device — Devices
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (4)
- Model Number: UHI-3
- UDI-DI: 04953170140280
- 04953170140297
- All Serial Numbers.
Distribution
Distributed nationwide across the United States.
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