Moderate riskFDA DeviceClass II

Olympus High Flow Insufflation Unit UHI-4 recalled for unexpected display shutdown and air delivery loss

The Olympus UHI-4 insufflation unit may experience unexpected shutdowns where the front panel display turns off and air delivery stops during use. This affects about 3,087 units distributed worldwide. No injuries have been reported.

From the FDA notice · Read the official notice ↗ · All Olympus recalls

What to do

  1. If you operate an Olympus UHI-4, contact Olympus Corporation of the Americas for instructions on inspection or replacement.
  2. Do not use the device if the display has shut down unexpectedly or air delivery has stopped.

Is yours affected?

Compare your label or packaging with the recalled product.

Product
Olympus High Flow Insufflation Unit - UHI-4. Model Number: UHI-4
Sold in
Nationwide
Made for
All ages (0 months and older)

Details

Units affected
3,087 units
Illnesses reported
None reported
Manufactured in
3500 Corporate Pkwy, N/A, Center Valley, PA, United States
Classification
Class II
Recall number
Z-2776-2026

In the FDA's words

Description
Olympus High Flow Insufflation Unit - UHI-4. Model Number: UHI-4 Potential for unexpected instances where the front panel display turns off unexpectedly, and air delivery (insufflation) ceases. Model Number: UHI-4. UDI: 04953170324147, 04953170467219. All Serial Numbers. 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. Affected quantity: 3,087 units
Hazard
Potential for unexpected instances where the front panel display turns off unexpectedly, and air delivery (insufflation) ceases.

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