Reported Nov 19, 2025 · Ongoing
Brand Name: Olympus Single Use Single Use Electrosurgical Snare SD-400 Product Name: Single Use Single Use…
Olympus Corporation of the Americas
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: Olympus Corporation of the Americas · 3500 Corporate Pkwy · Center Valley, PA · 18034-8229
Is this the product you have?
- Brand NameOlympus Single Use Single Use Electrosurgical
- Snare SD-400 Product NameSingle Use Single Use Electrosurgical
- Snare Model/Catalog NumberSD-U400U-15
- Product DescriptionThese instruments have been designed to be used with an Olympus endoscope for the removal and/or cauterization of diminutive polyps, sessile polyps, pedunculated polyps, and tissue from within the GI tract
- Lot codes and dates
- ModelSD-400U-15
- Lot Numbers
27V28V29V2XV2YV2ZV31V32V33V34V35V36V37V38V39V3XV3YV3ZV41V42V43V44V45V46V47V48V49V4XV4YV4ZV51V52V53V54V55V56V
- UDI04953170408250
- Amount recalled
- 18174 units
This recall covers 3 products
The agency filed one notice per product. You are reading one of them; the other 2 are below.
Where it was sold
- Nationwide
Why it was recalled
Sterility compromised from small holes that may occur during packaging of the device pouches into the shelf carton and/or during transportation of the shelf carton.
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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