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.
| Source | FDA Device Enforcement |
|---|---|
| Category | Medical Device |
| Severity | High |
| Status | ongoing |
| Recall date | January 16, 2026 |
| Reported | February 25, 2026 |
| Recalling firm | Olympus Corporation of the Americas |
| Country / region | United States PA |
Hazard
Issue with software algorithm which may lead to overpressure events.
Affected products
- Olympus High Flow Insufflation Unit. Model Number: UHI-3. Used for insufflation of the abdominal cavity, and automatic suction and smoke evacuation to facil
Related recalls
Swan-Ganz Jr Catheter, Models: SGPT54, SGPT64P, SGPT755PMedtronic DLP Retrograde Cannula Manual-Inflate Silicone Body 15FR, Model 94215T; Cardiopulmonary bypass vMedtronic DLP Retrograde Cannula Manual-Inflate Silicone Body 15FR, Model 94665; Cardiopulmonary bypass vaSwan-Ganz Catheter, Models: 131F7/131F7P, 131F7J, 141F7, 151F7, 834F75, 096F6/096F6P, C144F7, 782F75M, 132F5, Oncology Kit w/60" (152 cm) Appx 2.2 ml, Smallbore Ext Set w/ChemoLock Port, Clamp, Anti-Siphon Valve, Spiros;