FDA Device recall Z-1353-2026
Olympus High Flow Insufflation Unit
- FDA Device
- Class I
- ongoing
- Published 2026-02-25
On 2026-02-25 the FDA classified a Class I recall of Olympus High Flow Insufflation Unit by Olympus, citing issue with software algorithm which may lead to overpressure events.
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-1353-2026 |
| Classification | Class I |
| Status | ongoing |
| Initiated | 2026-01-16 |
| Published | 2026-02-25 |
| Last updated | 2026-09-13 11:58 UTC |
| Company | Olympus |
| Distribution | US |
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.
Identifiers
| code_info | Model Number: UHI-2; UDI-DI: N/A; All Serial Numbers |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:58 UTC. Current status: ongoing.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-1353-2026%22
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