FDA Medical devices recall ·
Olympus High Flow Insufflation Unit recall
This is an FDA Class I recall — the most serious type.
- Recall number
- Z-1354-2026
- Date
- (initiated January 16, 2026)
- Company / brand
- Olympus Corporation of the Americas
3500 Corporate Pkwy, Center Valley, PA, United States - Category
- Medical devices › Class I
- Classification
- Class I
- Status
- Ongoing
- Units affected
- 485 units
- Hazard tags
- Software
- Initiated by
- Voluntary: Firm initiated
Read the official FDA notice ↗
Product
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 was it recalled?
Issue with software algorithm which may lead to overpressure events.
What should you do?
FDA enforcement reports do not list a consumer remedy. Check the product codes below against what you have; if it matches, stop using it and follow the instructions in the firm's or FDA's official notice, or contact the company. If you have health concerns, contact your healthcare provider.
Product codes & lot numbers
Model Number: UHI-3; UDI-DI: 04953170140280, 04953170140297; All Serial Numbers.
Distribution
Nationwide distribution
What does Class I mean?
Class I is the most serious FDA recall class: there is a reasonable probability that using or being exposed to the product will cause serious adverse health consequences or death.
Source: FDA (medical devices), recall Z-1354-2026. Official notice. Republished from public data; RecallFlag is not affiliated with the FDA.