Olympus Corporation of the Americas: Medical Device Recall in 2024 - (Recall #: Z-2029-2024)

Updated on March 25, 2026.

See the recall detail below. You can also see other recalls from the same firm in 2024.

Data Source: FDA.

Product Description:

OES 4000 Hysteroscope, Model/Catalog Number: A4674A

Product Classification:

Class II

Date Initiated: April 18, 2024

Date Posted: June 12, 2024

Recall Number: Z-2029-2024

Event ID: 94638

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.

Status: Ongoing

Product Quantity: 1 unit

Code Information:

Model/Catalog Number: A4674A, UDI-DI: 04042761006361, Serial Number: 805904;

Distribution Pattern:

US Nationwide distribution in the state of NY.

Voluntary or Mandated:

Voluntary: Firm initiated