Olympus High Flow Insufflation Unit. Model/ Number: UHI-2. Used for insufflation of the abdominal cavity, and automa
Summary
The FDA issued a Class I for Olympus High Flow Insufflation Unit. Model/ Number: UHI-2. Used for insuffla by Olympus Corporation of the Americas. Reason: Issue with software algorithm which may lead to overpressure events..
Details
Source
Device Recall
External ID
Z-1353-2026
Action Date
2026-02-25
Status
Ongoing
Category
device
Product Description
Olympus High Flow Insufflation Unit. Model/ Number: UHI-2. Used for insufflation of the abdominal cavity, and automatic suction and smoke evacuation to facilitate laparoscopic observation and treatment within the abdominal cavity.
Lot/Code Info: Model Number: UHI-2; UDI-DI: N/A; All Serial Numbers
Quantity Affected: 744 units
Reason for Recall
Issue with software algorithm which may lead to overpressure events.
Distribution
Nationwide distribution
Type: Voluntary: Firm initiated
Recall Initiated: 2026-01-16
Company
Center Valley, PA
Context & Analysis
This is a Class I recall. Class I recalls are the most serious — there is a reasonable probability that use of or exposure to the product will cause serious health consequences or death.
This was one of 189 device recalls issued in the same week, part of 413 device-related FDA actions this month.
Olympus Corporation of the Americas has 334 FDA actions in our database, including 334 recalls.
Frequently Asked Questions
What is a Class I recall?
A Class I recall is the most serious type. The FDA has determined there is a reasonable probability that the product will cause serious adverse health consequences or death. Consumers should stop using the product immediately.
What should I do if I have this product?
Stop using the product. Check the product against the specific lot numbers or identifiers listed in the recall. Contact the manufacturer (Olympus Corporation of the Americas) or your retailer for a refund or replacement. If you experienced adverse effects, report them to the FDA via MedWatch.
How often does Olympus Corporation of the Americas have FDA actions?
Olympus Corporation of the Americas has 334 FDA actions in our database, including 334 recalls and 0 device clearances.
Where can I find the official FDA record?
The official record is available on FDA.gov. Search for "Z-1353-2026" on FDA.gov for the full record. You can also use the openFDA API to query this record programmatically.
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