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.
Olympus is recalling hysteroscopes with model number A4674A because a manufacturing defect might cause foggy images during use. This could interfere with medical procedures if the device is used without proper visibility.
The hysteroscope's eyepiece could become foggy due to liquid entering from a manufacturing defect. This might happen during rework of the device, but it does not cause physical harm or injury.
Medical professionals using Olympus OES 4000 hysteroscopes with model A4674A are most at risk. Patients undergoing procedures with these devices may experience reduced visibility.
Check for model number A4674A on the hysteroscope. Units sold in the U.S. between 2020 and 2021 with serial number 805904 are affected.
Look for model number A4674A on the hysteroscope to confirm if it's affected.
No serious injury risk. The hazard could cause foggy images during use but does not involve physical harm.
Check for model number A4674A and serial number 805904. Units sold in the U.S. between 2020 and 2021 are affected.
The recall does not specify a remedy. Contact Olympus Corporation of the Americas for further instructions.
We’ve drafted a message you can send Olympus to request your refund or repair — edit it as you like.
Subject: Recall Z-2029-2024 — Olympus Olympus Hello, I own a Olympus that is covered by recall Z-2029-2024 from Olympus. I’m writing to arrange the remedy described in the recall (a refund, repair, or replacement as applicable). Could you please tell me the next steps to resolve this? Thank you.
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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.
