FDA Device recall Z-2029-2024
OES 4000 Hysteroscope, Model/Catalog Number: A4674A
- FDA Device
- Class II
- ongoing
- Published 2024-06-12
On 2024-06-12 the FDA classified a Class II recall of OES 4000 Hysteroscope, Model/Catalog Number: A4674A by Olympus, citing 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.
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-2029-2024 |
| Classification | Class II |
| Status | ongoing |
| Initiated | 2024-04-18 |
| Published | 2024-06-12 |
| Last updated | 2026-09-13 11:57 UTC |
| Company | Olympus |
| Distribution | US |
Product
OES 4000 Hysteroscope, Model/Catalog Number: A4674A
Reason
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.
Identifiers
| code_info | Model/Catalog Number: A4674A, UDI-DI: 04042761006361, Serial Number: 805904; |
|---|
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-2029-2024%22
RecallRadar indexes public recall notices from the FDA, USDA FSIS, and CPSC. The official agency notice is the authoritative source. Always confirm details at the linked source before acting.