Olympus Corporation recalled 485 units of the High Flow Insufflation Unit, Model UHI-3, on January 16, 2026. The recall follows reports of a software algorithm issue that may cause overpressure events. 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 recalled product is the Olympus High Flow Insufflation Unit, Model Number UHI-3. It has a Unique Device Identifier (UDI-DI) of 04953170140280 and 04953170140297. The units were distributed nationwide.
The insufflation unit has a software algorithm issue that can lead to overpressure events. This condition poses serious risks during laparoscopic procedures, potentially causing injury.
No specific incidents, injuries, or deaths have been reported yet associated with this recall. The risk level is classified as high due to the potential for severe complications in medical settings.
Patients and healthcare providers should stop using the Olympus High Flow Insufflation Unit immediately. Follow the recall instructions provided by the manufacturer and contact Olympus Corporation of the Americas for further guidance.
For more information, contact Olympus Corporation of the Americas at their official website or by phone. The recall notification will be sent via letter.
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