Olympus Corporation of the Americas recalls Brand Name: Olympus Single Use Electrosurgical Snare SD-400 Product Name: Single Use Elec
- Recalling company
- Olympus Corporation of the Americas
- Product
- Brand Name: Olympus Single Use Electrosurgical Snare SD-400 Product Name: Single Use Electrosurgical Snare Model/Catalog Number: SD-400U-10 Product Description: These 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.
- Reason
- 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.
- Classification
- Class II – may cause temporary or medically reversible health consequences
- Recall date
- Oct 6, 2025
- Reported
- Nov 19, 2025
- Distribution
- Worldwide distribution - US Nationwide and the countries of GU, and MP.
- Status
- Ongoing
- Quantity
- 48208 units
- Lot / codes
- Model: SD-400U-10; Lot Numbers: 27V, 28V, 29V, 2XV, 2YV, 2ZV, 31V, 32V, 33V, 34V, 35V, 36V, 37V, 38V, 39V, 3XV, 3YV, 3ZV, 41V, 42V, 43V, 44V, 45V, 46V, 47V, 48V, 49V, 4XV, 4YV, 51V, 52V, 53V, 54V, 55V, 56V, 57V UDI: 04953170408243
- Company location
- Center Valley, PA
- Recall type
- Voluntary: Firm initiated
- Recall number
- Z-0482-2026
- Agency
- U.S. Food and Drug Administration (FDA)
View official FDA notice ↗ Search recall number Z-0482-2026 in the FDA Enforcement Report. Also see FDA recall press releases.
If you use this product, check the lot, NDC or model number against the official notice and follow its instructions. Do not stop a prescribed medicine or remove a medical device without talking to your doctor or pharmacist. Report problems to FDA MedWatch. FoodRecallNow summarizes public FDA data and is not medical advice.