Olympus Corporation Of The Americas recalls 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.

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.

• FDA enforcement recordOfficial FDA database entry for Z-2776-2026
• FDA 510(k) clearance · K243527The device's official FDA premarket clearance record
• FDA device classification · HIFOfficial FDA classification for this device type
• CFR regulation · 21 CFR 884.1730The federal regulation governing this device
• FDA recall announcementSearch FDA.gov for the official press announcement
• Find Olympus Corporation of the AmericasSearch for the manufacturer's official notice
• News coverageRecent reporting on this recall and manufacturer
• openFDA data recordThe raw JSON record this page is built from

Source: U.S. FDA openFDA device enforcement reports. This summary is informational and may lag or differ from the official record. Always verify against the FDA before acting.