Z-1354-2026 Class I Ongoing
FDA device recall Z-1354-2026 was initiated by Olympus Corporation of the Americas on January 16, 2026 and is designated Class I. Reason for recall: Issue with software algorithm which may lead to overpressure events. The recall status is ongoing. Affected quantity: 485 units.
Recall Details
- Product Type
- Devices
- Report Date
- February 25, 2026
- Initiation Date
- January 16, 2026
- Termination Date
- N/A
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 485 units
Product Description
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 for Recall
Issue with software algorithm which may lead to overpressure events.
Distribution Pattern
Nationwide distribution
Code Information
Model Number: UHI-3; UDI-DI: 04953170140280, 04953170140297; All Serial Numbers.