Olympus Recalls High Flow Insufflation Units Due to Overpressure Risk
Olympus Corporation of the Americas is recalling 485 UHI-3 High Flow Insufflation Units because a software defect may cause dangerous overpressure events during laparoscopic procedures.
What Happened
Olympus Corporation of the Americas has initiated a voluntary recall of its High Flow Insufflation Units, specifically Model UHI-3. The recall was triggered by an issue with the software algorithm which may lead to overpressure events while the device is in use.
Which Products Are Affected
The recall involves the following medical device:
- Product Name: Olympus High Flow Insufflation Unit
- Model Number: UHI-3
- UDI-DI: 04953170140280, 04953170140297
- Serial Numbers: All serial numbers are included in this recall
- Quantity: 485 units
- Distribution: Nationwide distribution across the United States
- Recall Number: Z-1354-2026
These units are designed for insufflation of the abdominal cavity, as well as automatic suction and smoke evacuation to facilitate laparoscopic observation and treatment.
What You Should Do
Olympus initiated the recall process by sending notification letters to affected customers on January 16, 2026. Healthcare facilities and providers using the UHI-3 model should follow the instructions provided in the firm’s correspondence. For further inquiries, the recalling firm is located at 3500 Corporate Pkwy, Center Valley, PA 18034.
Why This Matters
This is a Class I recall, the most serious classification, because the software defect can lead to overpressure in the abdominal cavity, posing a significant risk of injury or health complications to patients during surgery.
Source
Information provided by the FDA.
Source: FDA Official Notice