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Early Alert: Insufflation Unit Issue from Olympus
The FDA is aware that Olympus is removing High Flow Insufflation Unit models UHI, UHI-2, and UHI-3 due to a potential software algorithm issue which could lead to overpressure events. These products have been discontinued and not supported by repair for many years, and there is no corrective solution is available for the affected models.
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.
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.
Questions?
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.
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