Olympus recalls Hysterovideoscope model HYF-V due to potential water contamination in the channel after repair, which could lead to infection. Affected units were sold with model number HYF-V (04953170340185).
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 Hysterovideoscope models HYF-V because water in the channel after repair could cause infections. This is a safety issue for users who have had the device repaired.
The channel air drying process wasn't properly validated, so some scopes had water remaining after repair. This water could lead to contamination and infection if the device is used.
Users of the Olympus Hysterovideoscope model HYF-V (04953170340185) who have had the device repaired are most at risk. Healthcare providers using this model for endoscopic procedures may be affected.
Check for the model number HYF-V (04953170340185) on the device. The product is for endoscopic diagnosis within the uterus.
Inspect the channel for water after repair. If water is present, stop using the device.
The channel air drying process wasn't validated, so some scopes had water remaining after repair, which could lead to infection.
HYF-V (04953170340185).
The official recall record does not mention a remedy or fix.
We’ve drafted a message you can send Olympus to request your refund or repair — edit it as you like.
Subject: Recall Z-0336-2024 — Olympus Olympus Hello, I own a Olympus that is covered by recall Z-0336-2024 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.