Serious riskFDA DeviceFeb 25, 2026Class I

Olympus High Flow Insufflation Unit recalled for overpressure risk

Olympus has recalled its High Flow Insufflation Unit (Model UHI-2) used during abdominal surgery because a software problem may cause the device to create excessive pressure in the abdominal cavity. The issue affects all 744 units distributed nationwide. No injuries have been reported.

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

What to do

Stop using the Olympus UHI-2 insufflation unit immediately if your facility has one
Contact Olympus Corporation of the Americas for instructions on return or replacement
Notify your surgical team and equipment management of this recall

Official notice ↗

Is yours affected?

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

This recall covers 3 products — see all of them.

Details

Units affected: 744 units
Illnesses reported: None reported
Manufactured in: 3500 Corporate Pkwy, Center Valley, PA, United States
Classification: Class I
Recall number: Z-1353-2026

In the FDA's words

Description: 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. Issue with software algorithm which may lead to overpressure events. Model Number: UHI-2; UDI-DI: N/A; All Serial Numbers Distribution: Nationwide distribution Affected quantity: 744 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… (this page)
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…
Z-1354-2026 · 485 units