CLASS II ONGOING Device recall · Reported 3 Apr 2024 · FDA Enforcement Report

Insufflation unit, UHI recalled by Olympus Corporation of the

Olympus Corporation of the Americas is recalling Insufflation unit, UHI-4, distributed nationwide in the US. The recall was initiated on 25 Sep 2023 and the FDA has classified it as Class II.

Check your package

Lot, batch or date codesModel and serial number: UHI-4: UDI/DI: 04953170324147; All serial numbers.

Quantity recalled3,172 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-1375-2024
FDA event ID: 94080
Recalling firm: Olympus Corporation of the Americas, Center Valley, PA
Classification: Class II
Status: Ongoing
Recall initiated: 25 Sep 2023
FDA classified: 25 Mar 2024
Reported: 3 Apr 2024
Type: Voluntary: Firm initiated
Customers notified by: Letter
Reason category: Other Reasons
Device type: Other Medical Devices

Timeline

25 Sep 2023	Recall initiated by company
25 Mar 2024	Classified by FDA	+182 days
3 Apr 2024	Published in enforcement report	+9 days

Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.

Reason for recall

Olympus has become aware of an increased trend of both repairs and customer complaints reporting "UHI-4 stopping air supply due to the front panel LED turning off".

Product as listed by the FDA

Insufflation unit, UHI-4.

Where it was distributed

Domestic: Nationwide Distribution.

Nationwide

Questions about this recall

Why was it recalled?

Olympus has become aware of an increased trend of both repairs and customer complaints reporting "UHI-4 stopping air supply due to the front panel LED turning off".

Which lots are affected?

Model and serial number: UHI-4: UDI/DI: 04953170324147; All serial numbers.

Where was it sold?

Domestic: Nationwide Distribution.

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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