Class II

Medical Device Recall: OES 4000 Hysteroscope, Model/Catalog Number: A4674A

Olympus Corporation of the Americas · April 18, 2024

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.

Distribution

US Nationwide distribution in the state of NY.

States Affected

NATIONWIDE

Quantity Affected

1 unit

Source: FDA (openFDA Device Enforcement)

Recall number: Z-2029-2024

Status: ongoing

SafeCheck provides drug interaction information from FDA-approved product labeling (openFDA). This is for informational purposes only and is not medical advice. Always consult your healthcare provider before making medication decisions.

Olympus Corporation of the Americas Medical Device Recall: OES 4000 Hysteroscope, Model/Catalog Number: A4674A | SafeCheck