Olympus Corporation recalled 744 High Flow Insufflation Units on January 16, 2026. A software algorithm issue may lead to overpressure events during use. Patients and healthcare providers must stop using the device immediately.
Issue with software algorithm which may lead to overpressure events.
Patients and healthcare providers should stop using this device immediately. Follow the recall instructions provided by the manufacturer. Contact Olympus Corporation of the Americas or your healthcare provider for instructions. Notification method: Letter
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The Olympus High Flow Insufflation Unit is used in laparoscopic surgeries to insufflate the abdominal cavity. It allows for automatic suction and smoke evacuation, facilitating better observation and treatment.
The software algorithm issue can lead to overpressure situations, which may compromise patient safety during surgical procedures. This malfunction could lead to serious complications during laparoscopic surgery.
This recall is not part of a broader industry pattern.
Patients and healthcare providers face potential safety risks, necessitating immediate cessation of use to avoid serious injury.
Look for the model number and identification information on the device's label or documentation.
Expect a response from Olympus within 4-6 weeks regarding refund or replacement processes.
Keep records of all communications regarding the recall, including emails, letters, and phone calls.
The recalled product is the Olympus High Flow Insufflation Unit, Model UHI-2. It was distributed nationwide and sold to healthcare providers and institutions.
Not sure what to do next? Our guide walks you through the process step by step.
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