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 Olympus High Flow Insufflation Unit, Model UHI-3, is used during laparoscopic procedures for insufflation, suction, and smoke evacuation. Medical professionals rely on this device to create a clear view of the abdominal cavity for treatment.
The software algorithm malfunction can lead to overpressure in the abdominal cavity during procedures, which may result in serious complications for patients.
This recall is not part of a broader industry pattern.
The recall affects medical settings where the device is used, potentially delaying procedures and requiring alternative solutions until the issue is resolved.
The model number and UDI-DI can typically be found on the device's label or in the user manual.
Expect to receive further instructions and potential refunds within 4-8 weeks after the recall notification.
Keep copies of any correspondence with Olympus, receipts, and any documentation related to the recall for your records.
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.
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