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FDA-Device2026-02-25Class IPROCESSING DEFECT

Olympus High Flow Insufflation Unit Model UHI-2 recalled for overpressure software defect

Olympus
OTHERNationwide distribution

Stop using Olympus UHI-2 insufflation units

Olympus has recalled its High Flow Insufflation Unit (Model UHI-2) used during abdominal surgery because a software problem may cause the device to create excessive pressure in the abdominal cavity. The issue affects all 744 units distributed nationwide. No injuries have been reported.

  • Stop using the Olympus UHI-2 insufflation unit immediately if your facility has one
  • Contact Olympus Corporation of the Americas for instructions on return or replacement
  • Notify your surgical team and equipment management of this recall
Hazard

Issue with software algorithm which may lead to overpressure events.

Sold states
Nationwide distribution
Affected count
744 units
Manufactured in
3500 Corporate Pkwy, Center Valley, PA, United States
Products
Olympus High Flow Insufflation Unit. Model/ Number: UHI-2. 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-1353-2026

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