Potential health hazard — use of or exposure to this product may cause temporary or medically reversible adverse health consequences.
OES 4000 Hysteroscope Recalled by Olympus Corporation of the Americas Due to The required leakage test was not performed following...
What You Should Do
Stop using this product immediately. Do not consume, use, or distribute it.
Return the product to the place of purchase for a full refund. If you have questions, contact Olympus Corporation of the Americas directly.
Affected Products
OES 4000 Hysteroscope, Model/Catalog Number: A4674A
Quantity: 1 unit
Why Was This Recalled?
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.
Where Was This Sold?
This product was distributed nationwide across all 50 states.
About Olympus Corporation of the Americas
Olympus Corporation of the Americas has 378 total recalls tracked by RecallDetector.
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Data sourced from the FDA (Device). Last updated March 26, 2026. View original report