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

Lot, batch or date codesModel Number: UHI-4. UDI: 04953170324147, 04953170467219. All Serial Numbers.

Quantity recalled3,087 units

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.

Nationwide

Questions about this recall

Is Olympus High Flow Insufflation Unit - UHI-4 recalled?

Yes. Olympus Corporation of the Americas recalled Olympus High Flow Insufflation Unit - UHI-4 on 16 Jun 2026. The recall is Class II and its status is Ongoing. Recall number Z-2776-2026.

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?

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 21 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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