Olympus Recalls High Flow Insufflation Units Due to Overpressure Risk

What Happened

Olympus Corporation of the Americas has initiated a voluntary recall of its High Flow Insufflation Units, specifically Model UHI-3. The recall was triggered by an issue with the software algorithm which may lead to overpressure events while the device is in use.

Which Products Are Affected

The recall involves the following medical device:

• Product Name: Olympus High Flow Insufflation Unit
• Model Number: UHI-3
• UDI-DI: 04953170140280, 04953170140297
• Serial Numbers: All serial numbers are included in this recall
• Quantity: 485 units
• Distribution: Nationwide distribution across the United States
• Recall Number: Z-1354-2026

These units are designed for insufflation of the abdominal cavity, as well as automatic suction and smoke evacuation to facilitate laparoscopic observation and treatment.

What You Should Do

Olympus initiated the recall process by sending notification letters to affected customers on January 16, 2026. Healthcare facilities and providers using the UHI-3 model should follow the instructions provided in the firm’s correspondence. For further inquiries, the recalling firm is located at 3500 Corporate Pkwy, Center Valley, PA 18034.

Why This Matters

This is a Class I recall, the most serious classification, because the software defect can lead to overpressure in the abdominal cavity, posing a significant risk of injury or health complications to patients during surgery.

Source

Information provided by the FDA.