Olympus High Flow Insufflation Unit. Model Number: UHI-3. Used for insufflation of... recall (Olympus Corporation of the Americas)
Medical deviceClass IOngoing
Summary: Olympus Corporation of the Americas is recalling Olympus High Flow Insufflation Unit. Model Number: UHI-3. Used for insufflation of the abdominal cavity, and automatic suction and smoke evacuation to facilitate laparoscopic observation and treatment within the abdominal cavity.. Reason: Issue with software algorithm which may lead to overpressure events.
What is being recalled
Olympus High Flow Insufflation Unit. Model Number: UHI-3. Used for insufflation of the abdominal cavity, and automatic suction and smoke evacuation to facilitate laparoscopic observation and treatment within the abdominal cavity.
Why
Issue with software algorithm which may lead to overpressure events.
How serious is it
Class I is the most serious level: FDA considers there is a reasonable probability that using or being exposed to this product will cause serious health problems or death.
Where it was sold
Nationwide distribution
How to tell if yours is affected
Model Number: UHI-3; UDI-DI: 04953170140280, 04953170140297; All Serial Numbers.
What to do
Check the model, lot or serial numbers above against your device. If yours is affected, contact the manufacturer or your healthcare provider before you stop using a device you rely on.
Recall facts
| Recall number | Z-1354-2026 |
| Category | Medical device |
| Agency | U.S. Food and Drug Administration (FDA) |
| Severity | Class I |
| Status | Ongoing |
| Recall started | January 16, 2026 |
| Reported | February 25, 2026 |
| Company | Olympus Corporation of the Americas |
| Company location | Center Valley, PA, United States |
| Initiated by | Voluntary: Firm initiated |
| Quantity | 485 units |
More recalls from Olympus Corporation of the Americas · all medical device recalls · recalls from January 2026