Olympus UHI-4 Insufflation Unit Recall

Source: FDA · United States

Areazine synthesizes this FDA recall directly from FDA's official public data feed. See our methodology for full source attribution and refresh cadence.

Olympus Corporation of the Americas is recalling 3,087 units of the UHI-4 High Flow Insufflation Unit worldwide due to potential display failure and cessation of insufflation.

What this FDA recall tells you, and what most readers miss

This notice was issued by FDA on August 12, 2026 and geographically references United States. Its severity classification of "medium" signals how the issuing agency weighs the risk of harm if no action is taken - "critical" and "high" tier alerts typically carry direct consumer actions, while "medium" and "low" tend toward informational guidance or monitoring advisories. The category it belongs to - FDA Recalls - determines the consumer-protection framework behind it, which shapes what remedies (refunds, replacements, repairs, or the recall itself) are available to affected consumers and which agency holds statutory responsibility for enforcement.

Most readers skim a notice like this, check whether they are personally affected, and move on. The more useful lens is to verify its scope, source, and timestamp, then compare related notices without assuming that one record proves a broader trend.

Areazine pairs this record with the original agency URL so you can check the primary source before acting. Its related labels are recall, product-safety, fda, medical-device.

What Happened

The recall was initiated due to the potential for unexpected instances where the front panel display turns off unexpectedly, and air delivery (insufflation) ceases.

Which Products Are Affected

Olympus High Flow Insufflation Unit - UHI-4. Model Number: UHI-4. UDI: 04953170324147, 04953170467219. All Serial Numbers. 3,087 units. Distributed worldwide including 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, and Vietnam.

What You Should Do

The recall is voluntary and firm-initiated via letter notification. No additional consumer instructions are provided in the source data.

Why This Matters

This Class II recall involves 3,087 medical devices distributed globally that may experience unexpected loss of display and insufflation function.

Source

FDA recall number Z-2776-2026. Recalling firm: Olympus Corporation of the Americas, Center Valley, PA. Report date 20260729.

Original source: FDA Official Notice ↗

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Nationwide notices with similar length or severity timing 8

Two Areazine-derived peer sets for this FDA recall: nearest notices by body length and by same severity near the same agency date. Peers come from other categories so they are not the same-feed Related list above.

Frequently Asked Questions

Common questions about this FDA recall.

What is this FDA recall about?
Olympus Corporation of the Americas is recalling 3,087 units of the UHI-4 High Flow Insufflation Unit worldwide due to potential display failure and cessation of insufflation.
Which agency issued this alert?
This alert was issued by FDA. The original notice is available at the source link at the bottom of this article.
How severe is this alert?
This alert is classified as "medium" severity. Stay informed and follow agency guidance.
What area is affected?
This alert affects United States. Check with FDA for the most current geographic scope.
Where can I find more FDA Recalls updates?
Browse the full FDA Recalls feed on Areazine at areazine.com/recalls/fda/ for the latest updates from FDA and other agencies.