OES 4000 Hysteroscope — Class II medical device recall Z-2029-2024
Ongoing recall by Olympus Corporation of the Americas, reported 2024-06-12, distributed nationwide. The required leakage test was not performed following of a re-work for a non-conformity. This could potentiall
| Recall number | Z-2029-2024 |
|---|---|
| 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 | 2024-04-18 |
| Classified | 2024-06-06 |
| Reported by FDA | 2024-06-12 |
| Distributed | Nationwide (US) |
| Quantity | 1 units |
| Reason classes | packaging |
| UPC / GTIN / UDI-DI | 04042761006361 |
| Serial numbers | 805904 |
| Model numbers | A4674A |
Product
OES 4000 Hysteroscope, Model/Catalog Number: A4674A
Reason for recall
The required leakage test was not performed following of a re-work for a non-conformity. This could potentially result in liquid ingress into the eyepiece and cause a foggy image.
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-2029-2024. 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.