Recall
FDAHealthJune 16, 2026

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

⚠️ Potential for unexpected instances where the front panel display turns off unexpectedly, and air delivery (insufflation) ceases.

Is this relevant to me?

Geography
Nationwide
Source agency
FDA
Category
Health
Published
June 16, 2026

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.

What's affected?

Product
Olympus High Flow Insufflation Unit - UHI-4. Model Number: UHI-4
Lot code
Model Number: UHI-4. UDI: 04953170324147, 04953170467219. All Serial Numbers.

Additional details

Model Number: UHI-4. UDI: 04953170324147, 04953170467219. All Serial Numbers.

What should I do?

Recommended action

Class II recall. Voluntary: Firm initiated Quantity affected: 3,087 units.

View original FDA notice →

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