The Recall Desk
SevereFDA (Devices)·Z-1352-2026·Announced 2026-02-25

Olympus High Flow Insufflation Unit Recalled Due to Software Algorithm Issue

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

What this means for you

Illness, injury, or structural failure has been reported. Stop using the product immediately and contact the manufacturer for a refund or repair.

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 Number UHI. This device is used for abdominal cavity insufflation, as well as automatic suction and smoke evacuation during laparoscopic procedures.

The recall is due to a software algorithm issue that may lead to overpressure events during use.

This recall affects 18 units with all serial numbers and has been distributed nationwide.

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 — Surgical Equipment
Hazard
Affected units
18

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.

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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