Olympus High-Flow Insufflation Unit — Class I medical device recall Z-0075-2024
Ongoing recall by Olympus Corporation of the Americas, reported 2023-10-25, distributed nationwide. There have been reports of patients suffering arrhythmias, reported as short cardiac arrests, during surgical
| Recall number | Z-0075-2024 |
|---|---|
| Product type | Medical device |
| Classification | Class I |
| Status | Ongoing |
| Voluntary or mandated | Voluntary |
| Recalling firm | Olympus Corporation of the Americas, Center Valley, PA, United States |
| Recall initiated | 2023-09-22 |
| Classified | 2023-10-18 |
| Reported by FDA | 2023-10-25 |
| Distributed | Nationwide (US) |
| Quantity | 3,136 units |
| UPC / GTIN / UDI-DI | 04953170324147 |
| Model numbers | UHI-4 |
Product
Olympus High-Flow Insufflation Unit, Model UHI-4. For laparoscopic surgery.
Reason for recall
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.
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-0075-2024. 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.