Serious riskFDA DeviceFeb 25, 2026Class I

Olympus High Flow Insufflation Unit recalled for overpressure risk

Olympus Corporation is recalling the High Flow Insufflation Unit (Model UHI) used during abdominal surgery due to a software problem that may cause overpressure events. The device is used to inflate the abdominal cavity and remove smoke during laparoscopic surgery. No injuries have been reported.

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

What to do

Stop using the Olympus UHI insufflation unit immediately
Contact Olympus Corporation for replacement or repair instructions
Notify your surgical facility or hospital that you have this device

Official notice ↗

Is yours affected?

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

This recall covers 3 products — see all of them.

Details

Units affected: 18 units
Illnesses reported: None reported
Manufactured in: 3500 Corporate Pkwy, Center Valley, PA, United States
Classification: Class I
Recall number: Z-1352-2026

In the FDA's words

Description: 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. Issue with software algorithm which may lead to overpressure events. Model Number: UHI; UDI-DI: N/A; All Serial Numbers Distribution: Nationwide distribution Affected quantity: 18 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… (this page)
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…
Z-1354-2026 · 485 units