FDA-Device2026-02-25Class IPROCESSING DEFECT
Olympus High Flow Insufflation Unit Model UHI-3 recalled for overpressure software defect
OTHERNationwide distribution
Contact Olympus about UHI-3 insufflation unit recall
Olympus has recalled the High Flow Insufflation Unit Model UHI-3 due to a software algorithm issue that can cause overpressure events during abdominal cavity insufflation procedures. This medical device is used in laparoscopic surgery to maintain proper pressure and clear the surgical field. No injuries have been reported.
- If your facility uses an Olympus UHI-3 unit, contact Olympus Corporation of the Americas immediately for instructions
- Do not use the device until you receive guidance from Olympus
- Check the model number and serial number on your device to confirm if it is affected
Hazard
Issue with software algorithm which may lead to overpressure events.
Sold states
Nationwide distribution
Affected count
485 units
Manufactured in
3500 Corporate Pkwy, Center Valley, PA, United States
Products
Olympus High Flow Insufflation Unit. Model Number: UHI-3. Used for insufflation of the abdominal cavity, and automatic suction and smoke evacuation to facilitate laparoscopic observation and treatment within the abdominal cavity.
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1354-2026More Olympus Corporation of the Americas recalls
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