The Recall Desk
CriticalFDA (Devices)·Z-1353-2026·Announced 2026-02-25

Olympus High Flow Insufflation Unit Model UHI-2 Recalled Due to Software Issue

Olympus Corporation of the Americas is recalling 744 Olympus High Flow Insufflation Units (Model UHI-2) because a software algorithm issue may cause overpressure events.

What this means for you

Highest-severity recall. Risk of serious injury or death is documented or strongly suspected. Stop using the product now and follow the agency's instructions.

Our severity reasoning: The recall is classified as FDA Class I, which indicates a situation where there is a reasonable probability that the use of or exposure to a violative product will cause serious adverse health consequences or death.

Plain-English summary

Olympus Corporation of the Americas is recalling the Olympus High Flow Insufflation Unit, Model UHI-2. This device is used for abdominal cavity insufflation, as well as automatic suction and smoke evacuation during laparoscopic procedures.

A software algorithm issue in the device may lead to overpressure events during use.

This recall affects 744 units distributed nationwide. Users should follow manufacturer instructions regarding the affected devices.

The recalled product

Product
Olympus High Flow Insufflation Unit. Model/ Number: UHI-2. 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 — Surgical Equipment
Hazard
Affected units
744

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-2
  • UDI-DI: N/A
  • All Serial Numbers

Distribution

Distributed nationwide across the United States.

Part of a larger recall action

This product is one of 3 recalled by Olympus Corporation of the Americas under a single FDA (Devices) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.

See all 3 products in this recall →

Related recalls

Same manufacturer · Olympus Corporation of the Americas

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Same hazard · software error

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