Olympus Corporation of the Americas: Brand Name: Olympus Single Use Single Use Electrosurg

Olympus Corporation of the Americas: Brand Name: Olympus Single Use Single Use Electrosurgical Snare SD-400 Product Name: Single Use Single Use Electrosurgical Snare Model/Cat

Medical DevicesSource: FDA (device) · Date: 2025-11-19

The text below is copied from the official FDA (device) record. If anything differs, the official notice is correct.

Company / brand: Olympus Corporation of the Americas
Product: Brand Name: Olympus Single Use Single Use Electrosurgical Snare SD-400 Product Name: Single Use Single Use Electrosurgical Snare Model/Catalog Number: SD-U400U-15 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 / hazard: 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
Status: Ongoing
Distribution / sold at: Worldwide distribution - US Nationwide and the countries of GU, and MP.
Recall initiated: 2025-10-06
Code info: Model: SD-400U-15; 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, 4ZV, 51V, 52V, 53V, 54V, 55V, 56V UDI: 04953170408250
Product quantity: 18174 units
Voluntary mandated: Voluntary: Firm initiated
City: Center Valley
State: PA
Country: United States
Event id: 97733