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

FDA device recall Z-2776-2026 · posted 2026-07-22 · Open, Classified

Recall details

Recalling firm

Olympus Corporation of the Americas

Reason for recall

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

Action taken

Olympus notified consignees on about 06/16/2026 via letter. Consignees were informed that they many continue to use their UHI-4 until the offset adjustment is performed. However, as noted in the Instructions for Use (IFU), prepare a spare UHI-4 unit as a backup to ensure uninterrupted operation can be completed without complication in the case of a malfunction. Actions to take included to carefully read the notification letter and ensure all personnel are completely knowledgeable on the content of the notification, an Olympus field service representative will contact you to schedule a mutually convenient time to perform the offset adjustment, acknowledge receipt of the notification through the Olympus recall web portal, and forward the notification to other users who may have the affected products if you have further distributed it.

Root cause

Nonconforming Material/Component

Status

Open, Classified

Product code

HIF

Quantity affected

3,087 units

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,

Date initiated

2026-06-16

Date posted

2026-07-22

Location

Center Valley, PA

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