An important medical device safety announcement was made on January 26, 2026, regarding certain Olympus insufflation units. Healthcare professionals and medical institutions should be aware of this issue as it pertains to patient safety during laparoscopic procedures.
What Changed?
Olympus has issued a letter to affected customers recommending the removal of specific High Flow Insufflation Units from use or sale. The affected devices include the High Flow Insufflation Unit models UHI, UHI-2, and UHI-3.
Which Devices Are Affected?
The High Flow Insufflation Units in question have been discontinued and are no longer supported by repair. Olympus has decided to remove these devices from the market due to a software algorithm issue that could lead to overpressure events. The company stated that no corrective solution is available for the affected models.
Device Details
The UHI, UHI-2, and UHI-3 models are designed for insufflating the abdominal cavity and providing automatic suction and smoke evacuation during laparoscopic procedures. However, the potential for overpressure poses serious risks to patients, including air embolism, arrhythmias, pneumothorax, kidney or urinary problems, hypoxia, subcutaneous emphysema, and potentially death.
What Actions Are Required?
Healthcare professionals and institutions must immediately cease using the affected devices and quarantine them. If these products have been further distributed, notice of this recall should be forwarded to other users and facilities. Checking the FDA website for updates and reporting any adverse reactions or quality problems to MedWatch is also crucial.
Reporting Adverse Events
For any adverse reactions, quality problems, or questions about this recall, customers in the U.S. should contact Olympus at 1-800-848-9024 and select option 1. The Unique Device Identifier (UDI) system helps in identifying individual medical devices and facilitates more accurate reporting and analysis of adverse events.
Conclusion
In conclusion, the FDA’s early alert regarding Olympus’ insufflation units highlights the importance of vigilance in medical device safety. Immediate action is necessary to prevent potential harm to patients. Healthcare professionals and institutions must take the recommended steps to address this issue promptly.
Disclaimer
This information is provided as a public service and is not intended to be legal advice. Healthcare professionals should consult the original FDA announcement and relevant guidelines for comprehensive information.
FDA Announcement
For full information about the FDA announcement, see the link below.
https://www.fda.gov/medical-devices/medical-device-recalls-and-early-alerts/early-alert-insufflation-unit-issue-olympus