[pending] Olympus High Flow Insufflation Unit. Model Number: UHI. Used for insufflation of the abdominal c
Pending LLM rewrite. Source: FDA_DEVICE Z-1352-2026.
What this means for you
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: Pending LLM scoring against the rubric.
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. 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 (3)
- Model Number: UHI
- UDI-DI: N/A
- All Serial Numbers
Distribution
Distributed nationwide across the United States.
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