Recall Z-2776-2026 ยท HIF Insufflator, Laparoscopic
Olympus Corporation of the Americas
Olympus High Flow Insufflation Unit - UHI-4. Model Number: UHI-4
| Date | Jul 22, 2026 (initiated Jun 16, 2026) |
| Status | Open, Classified |
| 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 mutuall |
| 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, |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K243527 | High Flow Insufflation Unit (UHI-4) Olympus Medical Systems Corporation, Jan 13, 2025 |