Olympus Recalls High Flow Insufflation Units Over Software-Related Overpressure Risk

What Happened

Olympus Corporation of the Americas has initiated a voluntary recall of its High Flow Insufflation Units, Model UHI-2. The recall was triggered by a defect in the device’s software algorithm, which may cause the unit to create overpressure events during medical procedures. This recall has been classified as Class I by the FDA, indicating a high level of severity.

Which Products Are Affected

The recall impacts the following medical device:

• Product Name: Olympus High Flow Insufflation Unit
• Model Number: UHI-2
• Quantity: 744 units
• Affected Serial Numbers: All serial numbers are included in this recall.
• Geographic Scope: These units were distributed nationwide across the United States.

The device is used for the insufflation of the abdominal cavity, as well as automatic suction and smoke evacuation to facilitate laparoscopic observation and treatment.

What You Should Do

Olympus began notifying customers of the issue via a formal letter on January 16, 2026. Healthcare facilities and providers in possession of these units should follow the specific guidance provided in the firm’s notification. For additional information or inquiries regarding the recall process, the recalling firm can be contacted at their headquarters:

Olympus Corporation of the Americas 3500 Corporate Pkwy Center Valley, PA 18034-8229

Why This Matters

This is a Class I recall, the most serious classification, because the software issue poses a significant risk. Overpressure in the abdominal cavity during laparoscopic surgery can lead to serious patient complications or injury.

Source

Information provided by the FDA under recall number Z-1353-2026.