FDA Device recall Z-1375-2024
Insufflation unit, UHI-4
- FDA Device
- Class II
- ongoing
- Published 2024-04-03
On 2024-04-03 the FDA classified a Class II recall of Insufflation unit, UHI-4 by Olympus, citing olympus has become aware of an increased trend of both repairs and customer complaints reporting "UHI-4 stopping air supply due to the front panel LED turning off".
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-1375-2024 |
| Classification | Class II |
| Status | ongoing |
| Initiated | 2023-09-25 |
| Published | 2024-04-03 |
| Last updated | 2026-09-13 11:57 UTC |
| Company | Olympus |
| Distribution | US |
Product
Insufflation unit, UHI-4.
Reason
Olympus has become aware of an increased trend of both repairs and customer complaints reporting "UHI-4 stopping air supply due to the front panel LED turning off".
Identifiers
| code_info | Model and serial number: UHI-4: UDI/DI: 04953170324147; All serial numbers. |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:57 UTC. Current status: ongoing.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-1375-2024%22
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