Insufflation unit — Class II medical device recall Z-1375-2024
Ongoing recall by Olympus Corporation of the Americas, reported 2024-04-03, distributed nationwide. Olympus has become aware of an increased trend of both repairs and customer complaints reporting "UHI-4 stoppi
| Recall number | Z-1375-2024 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Ongoing |
| Voluntary or mandated | Voluntary |
| Recalling firm | Olympus Corporation of the Americas, Center Valley, PA, United States |
| Recall initiated | 2023-09-25 |
| Classified | 2024-03-25 |
| Reported by FDA | 2024-04-03 |
| Distributed | Nationwide (US) |
| Quantity | 3,172 units |
| UPC / GTIN / UDI-DI | 04953170324147 |
| Serial numbers | UHI-4 |
Product
Insufflation unit, UHI-4.
Reason for recall
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".
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/Z-1375-2024. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.