Olympus recalls Hysterofiberscope model HYF-XP due to potential water contamination in the channel that could lead to infection. Affected units sold between 2021-2023.
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 Hysterofiberscope endoscopes with model number HYF-XP because water in the channel after repair could cause infections. 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 after repair had water left inside. This water could lead to contamination and infection if the scope is used without proper cleaning.
Medical professionals using the Hysterofiberscope for uterine endoscopy are most at risk. Patients receiving procedures with these scopes could also be affected if contamination occurs.
Check for model number HYF-XP on the device. Units were sold between 2021 and 2:2023. The unique identifier (UDI-DI) is HYF-XP (04953170340178).
Inspect the channel for water after repair to ensure it's dry before use.
This recall is for medical professionals using the Hysterofiberscope for uterine procedures. Patients are not directly affected unless the scope becomes contaminated.
Check for model number HYF-XP. Affected units were sold between 2021 and 2023 with UDI-DI HYF-XP (04953170340178).
No immediate stop is required. Check for water in the channel after repair to ensure it's dry before use.
We’ve drafted a message you can send Olympus to request your refund or repair — edit it as you like.
Subject: Recall Z-0337-2024 — Olympus Olympus Hello, I own a Olympus that is covered by recall Z-0337-2024 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.
