Olympus Corporation of the Americas recalls Olympus High Flow Insufflation Unit.
- Recalling company
- Olympus Corporation of the Americas
- Product
- Olympus High Flow Insufflation Unit. Model/ Number: UHI-2. 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.
- Classification
- Class I – a reasonable probability that use will cause serious adverse health consequences or death
- Recall date
- Jan 16, 2026
- Reported
- Feb 25, 2026
- Distribution
- Nationwide distribution
- Status
- Ongoing
- Quantity
- 744 units
- Lot / codes
- Model Number: UHI-2; UDI-DI: N/A; All Serial Numbers
- Company location
- Center Valley, PA
- Recall type
- Voluntary: Firm initiated
- Recall number
- Z-1353-2026
- Agency
- U.S. Food and Drug Administration (FDA)
View official FDA notice ↗ Search recall number Z-1353-2026 in the FDA Enforcement Report. Also see FDA recall press releases.
If you use this product, check the lot, NDC or model number against the official notice and follow its instructions. Do not stop a prescribed medicine or remove a medical device without talking to your doctor or pharmacist. Report problems to FDA MedWatch. FoodRecallNow summarizes public FDA data and is not medical advice.