FDA-Device2026-02-25Class IPROCESSING DEFECT
Olympus High Flow Insufflation Unit Model UHI-2 recalled for overpressure software defect
What this means
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
The agency's original wording
Hazard
Issue with software algorithm which may lead to overpressure events.
Intended for
Adults
Illnesses reported
None reported
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-1353-2026More Olympus recalls
- FDA-Device2026-07-29Olympus OEV321UH 4K UHD LCD Monitor recalled for faulty HDMI and DisplayPort connectors
- FDA-Device2026-07-29Olympus High Flow Insufflation Unit UHI-4 recalled for unexpected display shutdown and air delivery loss
- FDA-Device2026-07-22Olympus Toomey Evacuator 50cc Model 188A recalled for inadequate sterilization parameters
- FDA-Device2026-07-22Olympus Glass Body for 194 Ellik Evacuator recalled for inadequate sterilization
- FDA-Device2026-07-22Olympus Toomey Evacuator 30cc with Adaptor recalled for inadequate sterilization
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