Serious riskFDA DeviceFeb 25, 2026Class I

Olympus High Flow insufflation unit recalled for potential overpressure risk

Olympus has recalled the High Flow Insufflation Unit Model UHI-3 due to a software algorithm issue that can cause overpressure events during abdominal cavity insufflation procedures. This medical device is used in laparoscopic surgery to maintain proper pressure and clear the surgical field. No injuries have been reported.

From the FDA notice · Read the official notice ↗ · All Olympus recalls

What to do

If your facility uses an Olympus UHI-3 unit, contact Olympus Corporation of the Americas immediately for instructions
Do not use the device until you receive guidance from Olympus
Check the model number and serial number on your device to confirm if it is affected

Official notice ↗

Is yours affected?

Compare your label or packaging with 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.
Sold in: Nationwide
Made for: All ages (0 months and older)

This recall covers 3 products — see all of them.

Details

Units affected: 485 units
Illnesses reported: None reported
Manufactured in: 3500 Corporate Pkwy, Center Valley, PA, United States
Classification: Class I
Recall number: Z-1354-2026

In the FDA's words

Description: 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. Issue with software algorithm which may lead to overpressure events. Model Number: UHI-3; UDI-DI: 04953170140280, 04953170140297; All Serial Numbers. Distribution: Nationwide distribution Affected quantity: 485 units
Hazard: Issue with software algorithm which may lead to overpressure events.

3 products in this recall

The agency lists each product separately. Check every one you might have.

Olympus High Flow Insufflation Unit. Model Number: UHI. Used for insufflation of the abdominal cavity, and automatic suction and smoke evacuation to faci…
Z-1352-2026 · 18 units
Olympus High Flow Insufflation Unit. Model/ Number: UHI-2. Used for insufflation of the abdominal cavity, and automatic suction and smoke evacuation to f…
Z-1353-2026 · 744 units
Olympus High Flow Insufflation Unit. Model Number: UHI-3. Used for insufflation of the abdominal cavity, and automatic suction and smoke evacuation to fa… (this page)
Z-1354-2026 · 485 units