Olympus recalls Hysteroscope HYF-1T models due to potential water contamination in the channel causing infection risk. Affected units may have water residue after repair, requiring immediate action.
Channel air drying process was not validated, and that a small percentage of scopes returned to customers after repair had a wet channel. Water remaining in the channel of the endoscopes has the potential for contamination that could lead to the risk of infection
Olympus is recalling Hyst: Hysteroscopes with model number HYF-1T because water can remain in the channel after repair, creating a risk of infection. This is a safety issue for medical users who might not notice the contamination.
The channel air drying process wasn't properly validated, so some scopes returned after repair had water left behind. This water can cause contamination, increasing the risk of infection during medical procedures.
Medical professionals using the Hysteroscope HYF-1T for endoscopic diagnosis within the uterus are most at risk. Patients using the device could also be affected if the contamination leads to infection.
Check for model number HYF-1T on the device. The product was sold with a unique identifier (UDI-DI) HYF-1T (04953170051128).
Inspect the channel for water after repair to determine if contamination is present.
The recall is for medical devices used by professionals; patients are not directly affected unless the device causes infection.
Look for model number HYF-1T on the device or unique identifier HYF-1T (04953170051128).
Check for water residue in the channel after repair. If present, contact Olympus 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-0335-2024 — Olympus Olympus Hello, I own a Olympus that is covered by recall Z-0335-2024 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.
