Drugs & medicalClass II

Olympus Corporation of the Americas recalls OES 4000 Hysteroscope, Model/Catalog Number: A4674A

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 notice →
Date
2024-06-12
Country
United States
Brand
Olympus Corporation of the Americas
Product
OES 4000 Hysteroscope, Model/Catalog Number: A4674A
Classification
Class II
Units
US Nationwide distribution in the state of NY.
Category
Drugs & medical
Source
FDA · Device

Copied automatically from the US Food and Drug Administration. Details may be shortened or out of date; the official notice is the authoritative source. Disclaimer

What to do

  1. Check the product name, strength and lot number against the official notice.
  2. Do not stop a prescribed medicine without talking to your doctor or pharmacist first.
  3. Ask the pharmacy or supplier about a replacement or refund.

General guidance from Recall Atlas. The official notice from the US Food and Drug Administration has the exact models, batch codes and remedy, and it takes priority.

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