Z-2776-2026Class II

Olympus Corporation of the Americas

What this record is not

A recall record is reproduced as FDA published it, and the classification is FDA’s. SPEQ adds no interpretation, and a recall concerns the products and dates in the record — it is not a statement about a company’s other products or its current status.

Recalling firm

Product type

Device

Status

Ongoing

Report date

2026-07-29

Distribution

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.

Firm state

Product quantity

3,087 units

Initiated by

Voluntary: Firm initiated

Reason for recall

Potential for unexpected instances where the front panel display turns off unexpectedly, and air delivery (insufflation) ceases.

Product description

Olympus High Flow Insufflation Unit - UHI-4. Model Number: UHI-4

Code / lot info

Model Number: UHI-4. UDI: 04953170324147, 04953170467219. All Serial Numbers.

Data: U.S. FDA. Recall details are as reported by the FDA. The quality-domain mapping and severity are a SPEQ editorial interpretation of the recall reason, not an official FDA classification. Open the enforcement explorer →