FDA recall, , Moderate risk
Olympus High Flow Insufflation Unit - UHI-4
The Olympus High Flow Insufflation Unit can have its front panel display turn off unexpectedly, and air delivery ceases.
Summary by Recall Canary from the FDA notice
What happened
Olympus Corporation of the Americas, located in Center Valley, Pennsylvania, began a recall of the Olympus High Flow Insufflation Unit - UHI-4 on June 16, 2026, because the front panel display can turn off unexpectedly, and air delivery (insufflation) ceases. The recall involves 3,087 units.
The product was distributed worldwide, including in the US Nationwide and in countries such as Australia, Canada, Germany, Japan, and the United Kingdom. The FDA added the recall to its Enforcement Report on July 22, 2026, and it was in the weekly enforcement report on July 29, 2026.
What to do
We don't have product-specific instructions for this recall. FDA's general advice for medical device recalls:
- A device recall doesn't always mean you must stop using it: it may need to be checked, adjusted or fixed.
- Talk to your health care provider before you stop using it.
Is yours affected?
Affected if its UDI-DI is listed.
A UDI-DI is the device identifier printed with the barcode on the device label.
Olympus High Flow Insufflation Unit - UHI-4.
- UDI-DI
- 04953170324147
- 04953170467219
- Lot code
- All Serial Numbers
Recall details
- Company began the recall
- Sold in
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.
- Company
- Olympus Corporation of the AmericasCenter Valley, Pennsylvania
- Hazard
- Device defect
- Risk
Moderate risk
Using it may cause short-term health problems, or ones that treatment can reverse. Serious harm is unlikely.
FDA Class II recall · How risk is rated
- Event ID
- 99109
- Recall number
- Z-2776-2026
- Quantity recalled
- 3,087 units
All recalls from Olympus Corporation of the Americas
Timeline
FDA's Enforcement Report is its public list of recalls; FDA adds a recall when it posts it and publishes the list weekly.
Company began the recall
Added to FDA's Enforcement Report · Classified by FDA
Listed on Recall Canary
In FDA's weekly enforcement report
Summary updated
