Reported Nov 29, 2023 · Ongoing
Hysterofiberscope-For endoscopic diagnosis within the uterus. Model Number: HYF-XP.
Aizu Olympus Co., Ltd.
Moderate riskThis product could cause temporary or reversible health problems — stop using it.What you should do
Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.
Firm contact: Aizu Olympus Co., Ltd. · 3 Chome 1-1 · Aizuwakamatsu, N/A · N/A
Is this the product you have?
- Hysterofiberscope-For endoscopic diagnosis within the uterus
- Model NumberHYF-XP
- Lot codes and dates
- Model Number (UDI-DI)HYF-XP (04953170340178)
- Amount recalled
- 16 units
This recall covers 22 products
The agency filed one notice per product. You are reading one of them; the other 21 are below.
9 more are in the archive.
Where it was sold
- Nationwide
Why it was recalled
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
This product could cause temporary or reversible health problems — stop using it.
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The guide adds the identifying codes laid out for scanning, symptoms to watch for, a timeline, and news coverage of this recall.
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