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Olympus Corporation of the Americas: Olympus High Flow Insufflation Unit - UHI-4. Model Number: UHI-4

Medical DevicesSource: FDA (device) · Date: 2026-07-29

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The text below is copied from the official FDA (device) record. If anything differs, the official notice is correct.

Company / brand
Olympus Corporation of the Americas
Product
Olympus High Flow Insufflation Unit - UHI-4. Model Number: UHI-4
Reason / hazard
Potential for unexpected instances where the front panel display turns off unexpectedly, and air delivery (insufflation) ceases.
Classification
Class II
Status
Ongoing
Distribution / sold at
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.
Recall initiated
2026-06-16
Code info
Model Number: UHI-4. UDI: 04953170324147, 04953170467219. All Serial Numbers.
Product quantity
3,087 units
Voluntary mandated
Voluntary: Firm initiated
City
Center Valley
State
PA
Country
United States
Event id
99109
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