Olympus Insufflation Units Recalled by FDA Due to Software Issues

The affected products and recommendations for what to do with the devices below have not changed. This recall **involves removing certain devices from where they are used or sold.* The FDA has identified this recall as the most serious type. This device may cause serious injury or death if you continue to use it.*

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:

| ### Device Name | ### Model Number | ### Serial Number |
| High Flow Insufflation Unit | UHI | All |
| High Flow Insufflation Unit | UHI-2 | All |
| High Flow Insufflation Unit | UHI-3 | All |

What to Do

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

On January 16, 2026, 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.

Reason for Recall

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, 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.

Additional FDA Resources

1. FDA Enforcement Report
2. CDRH Medical Device Recall Database

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.

Timeline of Communication Updates

| Date | Actions |
| --- | --- |
| 02/23/2026 | The FDA updated this communication
to inform the public that this issue has been
classified as a Class I Recall. |
| 01/22/2026 | The FDA issued an Early Alert
communication to notify the public of a
potentially high-risk device issue. |

• ## Content current as of:

02/23/2026

• Regulated Product(s)

  • Medical Devices