FDA DevicesClass I
Olympus High Flow Insufflation Unit. Model Number: UHI. Used for insufflatio...
Published: February 25, 2026Recall ID: Z-1352-2026Category: devicesCountry: US
Reason for Recall / Hazard
Issue with software algorithm which may lead to overpressure events.
Product Description & Identification
Olympus High Flow Insufflation Unit. Model Number: UHI. Used for insufflation of the abdominal cavity, and automatic suction and smoke evacuation to facilitate laparoscopic observation and treatment within the abdominal cavity.
Affected Products
Olympus High Flow Insufflation Unit. Model Number: UHI. Used for insufflation of the abdominal cavity, and automatic suction and smoke evacuation to facilitate laparoscopic observation and treatment within the abdominal cavity.
Additional Source Details
| Field | Value |
|---|---|
| City | Center Valley |
| State | PA |
| Event id | 98243 |
| Address 1 | 3500 Corporate Pkwy |
| Code info | Model Number: UHI; UDI-DI: N/A; All Serial Numbers |
| Postal code | 18034-8229 |
| Report date | 20260225 |
| Product type | Devices |
| Product quantity | 18 units |
| Reason for recall | Issue with software algorithm which may lead to overpressure events. |
| Voluntary mandated | Voluntary: Firm initiated |
| Recall initiation date | 20260116 |
| Initial firm notification | Letter |
| Center classification date | 20260218 |
Overview
- Recalling FirmOlympus Corporation of the Americas
- StatusOngoing
- Risk LevelClass I
- DistributionNationwide distribution