FDA Device recall Z-0075-2024
Olympus High-Flow Insufflation Unit, Model UHI-4. For laparoscopic surgery
- FDA Device
- Class I
- ongoing
- Published 2023-10-25
On 2023-10-25 the FDA classified a Class I recall of Olympus High-Flow Insufflation Unit, Model UHI-4. For laparoscopic surgery by Olympus, citing there have been reports of patients suffering arrhythmias, reported as short cardiac arrests, during surgical procedures where UHI-4s were used. These events may have been due to….
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-0075-2024 |
| Classification | Class I |
| Status | ongoing |
| Initiated | 2023-09-22 |
| Published | 2023-10-25 |
| Last updated | 2026-09-13 11:56 UTC |
| Company | Olympus |
| Distribution | US |
Product
Olympus High-Flow Insufflation Unit, Model UHI-4. For laparoscopic surgery.
Reason
There have been reports of patients suffering arrhythmias, reported as short cardiac arrests, during surgical procedures where UHI-4s were used. These events may have been due to an over insufflation of the abdominal cavity resulting from use of the UHI-4 during the procedures.
Identifiers
| code_info | UDI-DI: 04953170324147; All Serial Numbers |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:56 UTC. Current status: ongoing.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-0075-2024%22
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