Reported Feb 11, 2026 · Ongoing
Brand Name: CleverCut Product Name: Single Use 3-Lumen Sphincterotome V Model/Catalog Number: KD-V411M-0320; Software…
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 NameCleverCut
- Product NameSingle Use 3-Lumen
- Sphincterotome V Model/Catalog NumberKD-V411M-0320
- Software VersionN/A
- Product DescriptionThese instruments have been designed to be used with an Olympus endoscope and guidewire for papillotomy using high-frequency current
- Lot codes and dates
- Model/Catalog NumberKD-V411M-0320
- Material REF
(1) N1089430(2) N1089410(3) N5411130
- UDI-DI
(1) 04953170183973(2) 04953170466274(3) 04953170380556All Lots with a valid expiration date
- Amount recalled
- 72023 units (3920 US, 68103 OUS)
This recall covers 32 products
The agency filed one notice per product. You are reading one of them; the other 31 are below.
19 more are in the archive.
Where it was sold
Why it was recalled
Devices which did not undergo thermoforming could deform and lose performance.
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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