Olympus Recalls High Flow Insufflation Units Due to Software-Related Overpressure Risk

What Happened

Olympus Corporation of the Americas has initiated a voluntary recall of its High Flow Insufflation Units (Model UHI). The recall was prompted by the discovery of an issue within the device’s software algorithm that may lead to overpressure events during medical procedures. The FDA has designated this as a Class I recall, the most serious classification, indicating that the use of these devices may cause serious health consequences.

Which Products Are Affected

The recall involves the following medical device:

• Product Name: Olympus High Flow Insufflation Unit
• Model Number: UHI
• Recall Number: Z-1352-2026
• Quantity: 18 units
• Affected Codes: All Serial Numbers
• Distribution: Nationwide distribution across the United States

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

What You Should Do

The firm initiated the recall notification via letter on January 16, 2026. Healthcare facilities and providers in possession of these units should follow the specific instructions provided in the firm’s notification. For further inquiries, the recalling firm, Olympus Corporation of the Americas, is located at 3500 Corporate Pkwy, Center Valley, PA 18034-8229.

Why This Matters

Software-driven overpressure events during laparoscopic surgery pose a significant risk to patient safety, potentially leading to serious internal injury or complications during abdominal procedures.

Source

Information provided by the FDA. Recall Event ID: 98243.