CLASS II ONGOING Device recall · Reported 29 Jul 2026 · FDA Enforcement Report
Olympus High Flow Insufflation Unit - UHI recalled
Olympus Corporation of the Americas is recalling Olympus High Flow Insufflation Unit - UHI-4, distributed nationwide in the US. The recall was initiated on 16 Jun 2026 and the FDA has classified it as Class II.
Check your package
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
Recall details
- Recall number
- Z-2776-2026
- FDA event ID
- 99109
- Recalling firm
- Olympus Corporation of the Americas, Center Valley, PA
- Classification
- Class II
- Status
- Ongoing
- Recall initiated
- 16 Jun 2026
- FDA classified
- 22 Jul 2026
- Reported
- 29 Jul 2026
- Type
- Voluntary: Firm initiated
- Customers notified by
- Letter
- Reason category
- Other Reasons
- Device type
- Other Medical Devices
Timeline
| 16 Jun 2026 | Recall initiated by company | |
| 22 Jul 2026 | Classified by FDA | +36 days |
| 29 Jul 2026 | Published in enforcement report | +7 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
Reason for recall
Potential for unexpected instances where the front panel display turns off unexpectedly, and air delivery (insufflation) ceases.
Product as listed by the FDA
Olympus High Flow Insufflation Unit - UHI-4. Model Number: UHI-4
Where it was distributed
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.
Questions about this recall
Why was it recalled?
Potential for unexpected instances where the front panel display turns off unexpectedly, and air delivery (insufflation) ceases.
Which lots are affected?
Model Number: UHI-4. UDI: 04953170324147, 04953170467219. All Serial Numbers.
Where was it sold?
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 should I do if I have it?
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
What does Class II mean?
Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.
Read the official FDA notice · Source record retrieved 26 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.
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