Recall Z-2776-2026
Olympus Corporation of the Americas · initiated June 16, 2026
Class II – products that might cause a temporary health problem or pose a slight threat of a serious nature
Product
Olympus High Flow Insufflation Unit - UHI-4. Model Number: UHI-4
Codes / lots: Model Number: UHI-4. UDI: 04953170324147, 04953170467219. All Serial Numbers.
Reason for recall
Potential for unexpected instances where the front panel display turns off unexpectedly, and air delivery (insufflation) ceases.
FDA-determined cause: Nonconforming Material/Component
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.
Details
- Recall number
- Z-2776-2026
- Initiated
- June 16, 2026
- Posted by FDA
- July 22, 2026
- Product code
- HIF – Insufflator, Laparoscopic
- 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.
- Recalling firm
- Olympus Corporation of the Americas, Center Valley, PA