FDAHealthOctober 6, 2025
Olympus Corporation of the Americas — Brand Name: Olympus Single Use Electrosurgical Snare SD-400 Product Name: Single Use Electrosurgical Snare Model/Catalog Number: SD-400U-10 Product Description
⚠️ 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.
Is this relevant to me?
- Geography
- Nationwide
- Source agency
- FDA
- Category
- Health
- Published
- October 6, 2025
Worldwide distribution - US Nationwide and the countries of GU, and MP.
What's affected?
- 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.
- Lot code
- 27V
Additional details
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
What should I do?
Recommended action
Class II recall. Voluntary: Firm initiated Quantity affected: 48208 units.
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