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U.S. Department of Health and Human Services

Class 2 Device Recall Olympus High Flow Insufflation Unit UHI4

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 Class 2 Device Recall Olympus High Flow Insufflation Unit UHI4see related information
Date Initiated by FirmJune 16, 2026
Date PostedJuly 22, 2026
Recall Status1 Open3, Classified
Recall NumberZ-2776-2026
Recall Event ID 99109
510(K)NumberK243527 
Product Classification Insufflator, laparoscopic - Product Code HIF
ProductOlympus High Flow Insufflation Unit - UHI-4. Model Number: UHI-4
Code Information Model Number: UHI-4. UDI: 04953170324147, 04953170467219. All Serial Numbers.
FEI Number 2429304
Recalling Firm/
Manufacturer		 Olympus Corporation of the Americas
3500 Corporate Pkwy
Center Valley PA 18034-8229
For Additional Information ContactAshley Mitch
484-5531029
Manufacturer Reason
for Recall		Potential for unexpected instances where the front panel display turns off unexpectedly, and air delivery (insufflation) ceases.
FDA Determined
Cause 2		Nonconforming Material/Component
ActionOlympus 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 Commerce3,087 units
DistributionWorldwide 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.
Total Product Life CycleTPLC Device Report
1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 The manufacturer has initiated the recall and not all products have been corrected or removed. This record will be updated as the status changes.
510(K) Database510(K)s with Product Code = HIF
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