FDA Medical Device Recalls (openFDA)
Olympus Corporation of the Americas: Olympus High Flow Insufflation Unit - UHI-4. Model Number: UHI-4
- Recall number
- Z-2776-2026
- Recalling firm
- Olympus Corporation of the Americas
- Product
- Olympus High Flow Insufflation Unit - UHI-4. Model Number: UHI-4
- Status
- Open, Classified
- Initiated
- 2026-06-16
- Posted
- 2026-07-22
- Terminated
- not on file
- Reason
- Potential for unexpected instances where the front panel display turns off unexpectedly, and air delivery (insufflation) ceases.
- Root cause
- Nonconforming Material/Component
- Action
- 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.
- Quantity
- 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, Japan, Korea, Malaysia, Mexico, Myanmar, New Zealand, Paraguay, Peru, Russia, Singapore, Sri Lanka, Taiwan, Thailand, United Kingdom, Uruguay, Vietnam.
- Lot, serial or model codes
- Model Number: UHI-4. UDI: 04953170324147, 04953170467219. All Serial Numbers.
- 510(k) numbers
- ["K243527"]
- PMA numbers
- not on file
- Product code
- HIF
- Firm FEI
- 2429304
- Firm city
- Center Valley
- Firm state
- PA
- Firm country
- not on file
Where this comes from
- Register
- FDA Medical Device Recalls (openFDA)
- Publisher
- U.S. Food and Drug Administration (openFDA)
- File
- device-recall-0001-of-0001.json.zip
- sha256
- b87518bfe2e8
- Size
- 288210821 bytes
- Published
- 2026-09-28
- Read
- 2026-09-29T08:25:23.626Z
- Source file
- Source file retained · verify
- Refresh due
- 2026-10-06
Unless otherwise noted, the content, data, documentation, code, and related materials on openFDA is public domain and made available with a Creative Commons CC0 1.0 Universal dedication.
Cite as
FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28