FDA-Device2026-02-25Class IPROCESSING DEFECT
Olympus High Flow Insufflation Unit Model UHI-3 recalled for overpressure software defect
What this means
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
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
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 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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