Z-2776-2026Class II

Olympus High Flow Insufflation Unit - UHI-4. Model Number: UHI-4

Name: Z-2776-2026 Olympus High Flow Insufflation Unit - UHI-4. Model Number: UHI-4
Creator: Olympus Corporation of the Americas
Published: 2026-06-16
License: https://open.fda.gov/license/

OLYMPUS Corporation of the Americas / initiated 2026-06-16 / Open, Classified / root cause: manufacturing process

FDA source

Olympus Corporation of the Americas began a recall of Olympus High Flow Insufflation Unit - UHI-4. Model Number: UHI-4 on 2026-06-16. FDA classified it as Class II and gives the reason as "Potential for unexpected instances where the front panel display turns off unexpectedly, and air delivery (insufflation) ceases". As of 2026-09-10, the recall status on record is Open, Classified, and MDM tags the root cause as manufacturing process.

Recall record

Recall number: Z-2776-2026
Classification: Class II
Status: Open, Classified
Initiated: 2026-06-16
Posted: 2026-07-22
Recalling firm: OLYMPUS Corporation of the Americas
Product: Olympus High Flow Insufflation Unit - UHI-4. Model Number: UHI-4
Product code: HIF Insufflator, Laparoscopic
Reason for recall: Potential for unexpected instances where the front panel display turns off unexpectedly, and air delivery (insufflation) ceases.
Root cause tag: manufacturing process
FDA 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 in commerce: 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.
Product codes and lots: Model Number: UHI-4. UDI: 04953170324147, 04953170467219. All Serial Numbers.

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-2776-2026
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-2776-2026	Class II	Ongoing	Voluntary: Firm initiated	2026-07-29	2026-07-22

Product code HIF

K243527Class IIHigh Flow Insufflation Unit (UHI-4)Olympus Medical Systems Corporation / cleared 2025-01-13

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)