CDRH is issuing this Early Alert to notify the public of a potentially high-risk device issue. The FDA will keep the public informed and update this web page as significant new information becomes available.

Affected Product

The FDA is aware that Olympus has issued a letter to affected customers recommending certain High Flow Insufflation Units be removed from where they are used or sold.

Affected devices:

What to Do

Do not use affected devices. Identify and quarantine affected devices immediately.

On January 16, Olympus sent all affected customers a letter recommending the following actions:

• Examine your inventory and quarantine any identified devices immediately.
• Immediately cease usage of any UHI, UHI-2, and/or UHI-3 in your inventory.
• If you have further distributed this product, please forward this notice to other users and facilities.

Check this web page for updates. The FDA is currently reviewing information about this potentially high-risk device issue and will keep the public informed as significant new information becomes available.

Reason for Early Alert

Olympus stated that the software algorithm on High Flow Insufflation Unit, models UHI, UHI-2, and UHI-3, requires correction to address a potential issue which could lead to overpressure events. These products have been discontinued and have not been supported by repair for many years.  Because no corrective solution is available for the affected models, Olympus has decided to remove these devices from the market.

Over insufflation may lead to various patient harms during a procedure, including air embolism, arrythmias (bradycardia, asystole, or cardiac arrest), pneumothorax, kidney or urinary problems, hypoxia, subcutaneous emphysema, delay to treatment, more complex procedures, and potentially death.  

As of December 31, 2025, Olympus has reported two serious injuries, and no deaths associated with this issue.

Device Use

The UHI, UHI-2, and UHI-3 High Flow Insufflation Unit models are designed to insufflate the abdominal cavity and provide automatic suction and smoke evacuation to facilitate laparoscopic observation and treatment.

Contact Information

Customers in the U.S. with adverse reactions, quality problems, or questions about this recall should contact Olympus at 1- 800-848-9024 and select option 1.

Unique Device Identifier (UDI)  

The unique device identifier (UDI) helps identify individual medical devices sold in the United States from manufacturing through distribution to patient use. The UDI allows for more accurate reporting, reviewing, and analyzing of adverse event reports so that devices can be identified, and problems potentially corrected more quickly.  

How do I report a problem?  

Health care professionals and consumers may report adverse reactions or quality problems they experienced using these devices to MedWatch: The FDA Safety Information and Adverse Event Reporting Program.