Agency classClass IOur severity:Severe FDA (Devices)·Z-1354-2026·Announced 2026-02-25

Olympus High Flow Insufflation Unit Recalled Due to Software Overpressure Risk

Olympus is recalling 485 High Flow Insufflation Units (Model UHI-3) nationwide due to a software algorithm issue that may cause dangerous overpressure during abdominal surgery.

The agency’s classification

FDA (Devices): Class I

Class I is a situation in which there is a reasonable probability that the use of or exposure to a violative product will cause serious adverse health consequences or death.

This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work

What this means for you

Our assessment, not the agency’s: severity 4/5 (Severe).

The hazard poses a serious risk of illness, injury, or structural failure. Stop using the product immediately and contact the manufacturer for a refund or repair.

Our severity reasoning: FDA Class I medical device recall indicates a reasonable probability of causing serious adverse health consequences. The overpressure risk during abdominal surgery could result in tissue damage, organ perforation, or other significant injuries requiring hospitalization.

Plain-English summary

The U.S. Food and Drug Administration has announced a recall of 485 Olympus High Flow Insufflation Unit devices, Model Number UHI-3. These devices are used during laparoscopic surgery to insufflate the abdominal cavity with gas and to provide automatic suction and smoke evacuation.

The recall is being issued due to an issue with the software algorithm that may lead to overpressure events. Overpressure during insufflation could cause tissue damage, organ perforation, or other serious injuries during surgical procedures.

The affected devices were distributed nationwide and can be identified by Model Number UHI-3, UDI-DI numbers 04953170140280 and 04953170140297, and all serial numbers. The recalling firm, Olympus Corporation of the Americas, will notify affected customers directly.

Healthcare facilities and patients using these devices should immediately stop using them and contact Olympus Corporation of the Americas for replacement or repair. Physicians should consider alternative insufflation methods until the affected devices are replaced.

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 — Surgical Equipment
Hazard: overpressure
software-failure
surgical-trauma
Affected units: 485

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.

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 →

Same manufacturer · Olympus Corporation of the Americas

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