Visera Hysterovideoscope Olympus HYF Type V — Class II medical device recall Z-2480-2023
Ongoing recall by Olympus Corporation of the Americas, reported 2023-09-06, distributed nationwide. IFU labeling is being updated to revise EtO gas mixture and elimination of reusable cleaning brushes.
| Recall number | Z-2480-2023 |
|---|---|
| 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 | 2023-07-20 |
| Classified | 2023-08-29 |
| Reported by FDA | 2023-09-06 |
| Distributed | Nationwide (US) |
| Quantity | 363 units |
| Reason classes | labeling |
Product
Visera Hysterovideoscope Olympus HYF Type V
Reason for recall
IFU labeling is being updated to revise EtO gas mixture and elimination of reusable cleaning brushes.
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-2480-2023. 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.