HIGH FLOW INSUFFLATION UNIT recallZ-2776-2026 · Olympus Corporation of the Americas · initiated Jun 16, 2026
Open, Classified
Is my device affected?
- Compare the model, catalog and lot or serial numbers on your device or its packaging with the code information below. A recall usually covers only specific models or lots.
- If yours is listed, follow the instructions from Olympus Corporation of the Americas or your healthcare provider. The company's action is summarized under what the company is doing.
- Do not stop using a prescribed or implanted device on your own — talk to your healthcare provider first.
Where to find your model and lot numbers · What recall classes and statuses mean
Why it was recalled
Potential for unexpected instances where the front panel display turns off unexpectedly, and air delivery (insufflation) ceases.
FDA root cause category: Nonconforming Material/Component
What the company is doing
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.
Recall details
- Recall number
- Z-2776-2026
- Status
- Open, Classified
- Initiated by the company
- Jun 16, 2026
- Posted by the FDA
- Jul 22, 2026
- Recalling firm
- Olympus Corporation of the Americas
- Quantity
- 3,087 units
- Product code
- HIF
- FDA submissions
- K243527
- 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.
Product description
Olympus High Flow Insufflation Unit - UHI-4. Model Number: UHI-4
Code information (models, lots, serial numbers)
Model Number: UHI-4. UDI: 04953170324147, 04953170467219. All Serial Numbers.
Devices named in this recall
2 devices in the FDA device registry whose identifier appears in the recall's code information.
- HIGH FLOW INSUFFLATION UNIT UHI-4Olympus Medical Systems Corp. · INSUFFLATOR, AUTOMATIC CARBON-DIOXIDE FOR ENDOSCOPE3 recalls6 deaths2,484 reports
- HIGH FLOW INSUFFLATION UNIT UHI-4Olympus Medical Systems Corp. · Insufflator, Automatic Carbon-Dioxide For Endoscope1 recall9 reports
Product lines
Sources and updates
- Recall record: FDA Medical Device Recalls, file dated Oct 16, 2026 · View the FDA recall notice ↗
- Devices: FDA GUDID, file dated Oct 13, 2026. Devices are linked when their identifier (with a valid check digit) appears in the recall's code information.
- Page last rebuilt: Oct 16, 2026. Text above is shown as published by the FDA.
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