Lower riskMedical device recall · FDA · Published April 18, 2024
Olympus OES 4000 Hysteroscope Recall: Foggy Image Risk
Olympus recalls OES 4000 hysteroscopes with model A4674A due to potential foggy images from liquid ingress. Affected units sold in the U.S. from 2020-2021.
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.
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Contact the company
📍Recalling firmOlympus Corporation of the Americas3500 Corporate Pkwy · Center Valley, PA 18034-8229
“Olympus OES 4000 Hysteroscope Recall: Foggy Image Risk.” GovInfoNow, updated August 18, 2026. https://govinfonow.com/recall/55353-olympus-oes-4000-hysteroscope-recall-foggy-image-risk. Based on FDA recall #Z-2029-2024 (https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-2029-2024%22&limit=1).
The FDA announced on April 18, 2024, that Olympus Corporation of the Americas is recalling one OES 4000 Hysteroscope (Model A4674A) because a missed leakage test could allow liquid ingress and cause a foggy image. The recall was initiated voluntarily by the firm.
How to tell if you have it
Brand: Olympus
Product: OES 4000 Hysteroscope
Model/Catalog Number: A4674A
UDI-DI: 04042761006361
Serial Number: 805904
The hazard
The required leakage test was not performed following a re-work for a non-conformity. This could potentially result in liquid ingress into the eyepiece and cause a foggy image.
Context
GovInfoNow's records show Olympus Corporation of the Americas has 133 other recalls on record since August 18, 2017. Other recent recalls include the Olympus Tripp-Lite P580-025 DisplayPort Cable (August 27, 2026), the Olympus M3 Gold Autoclavable Lateral Telescope (August 24, 2026), and the BiCOAG Hemostasis Probe (August 19, 2026). Similar product recalls include the Olympus OER-Pro (October 31, 2025) and the Olympus OER-Elite (October 31, 2025).
How to tell if you have this one
Check for model number A4674A on the hysteroscope. Units sold in the U.S. between 2020 and 2021 with serial number 805904 are affected.
Brand
Olympus
Category
Medical device
Based on the official FDA remedy
What to do — step by step
Check Model Number
Look for model number A4674A on the hysteroscope to confirm if it's affected.
Where it went and when
Where it was distributed
Distributed nationwide.
Nationwide
Not listed
FDA distribution: “US Nationwide distribution in the state of NY.” States read from FDA’s own wording; “not listed” means the notice does not name it.
Distributed nationwide.
Recall timeline
FDA published this recall 55 days after the firm started it.
1Firm started the recall
2FDA classified it Class II
3Published in FDA’s Enforcement Report
Dates from the agency record only; steps without a date are left out.
The facts (hazard, remedy, dates, manufacturer) are pulled from the official FDA recall record. The plain-language summary and step-by-step checklist are written by GovInfoNow to make the official notice easier to act on — they don’t replace it.
Official source: FDA Recall #Z-2029-2024 (April 18, 2024) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for Z-2029-2024 to see it in context.
Plain-language summary written by qwen3:4b on August 18, 2026, from the official record above. Not reviewed by a person — if it conflicts with the FDA notice, the notice is correct. Report an error on this page.
GovInfoNow is an independent service and is not a government agency. We republish official FDA recall data; we don’t issue, amend or administer recalls.