FDA-Device2026-07-29Class IIPROCESSING DEFECT
Olympus High Flow Insufflation Unit UHI-4 recalled for unexpected display shutdown and air delivery loss
What this means
The Olympus UHI-4 insufflation unit may experience unexpected shutdowns where the front panel display turns off and air delivery stops during use. This affects about 3,087 units distributed worldwide. No injuries have been reported.
- If you operate an Olympus UHI-4, contact Olympus Corporation of the Americas for instructions on inspection or replacement.
- Do not use the device if the display has shut down unexpectedly or air delivery has stopped.
The agency's original wording
Hazard
Potential for unexpected instances where the front panel display turns off unexpectedly, and air delivery (insufflation) ceases.
Intended for
Adults
Illnesses reported
None reported
Sold states
Worldwide distribution - US Nationwide and the countries of Australia, Bolivia, Brazil, Canada, Chile, China, Colombia, Costa Rica, Ecuador, El Salvador, Germany, Honduras, Hong Kong, India, Ireland, Japan, Korea, Malaysia, Mexico, Myanmar, New Zealand, Paraguay, Peru, Russia, Singapore, Sri Lanka, Taiwan, Thailand, United Kingdom, Uruguay, Vietnam.
Affected count
3,087 units
Manufactured in
3500 Corporate Pkwy, N/A, Center Valley, PA, United States
Products
Olympus High Flow Insufflation Unit - UHI-4. Model Number: UHI-4
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-2776-2026More Olympus recalls
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