Olympus High Flow Insufflation Unit. Model Number: UHI. Used for insufflation of the abdomina...
FDA Recall #Z-1352-2026 — Class I — January 16, 2026
Product Description
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.
Reason for Recall
Issue with software algorithm which may lead to overpressure events.
Recalling Firm
Olympus Corporation of the Americas — Center Valley, PA
Classification
Class I — Reasonable probability of serious adverse health consequences or death.
Product Type
Devices
Product Quantity
18 units
Distribution
Nationwide distribution
Code Information
Model Number: UHI; UDI-DI: N/A; All Serial Numbers
Status
Ongoing
Voluntary / Mandated
Voluntary: Firm initiated