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Recall Observatory FDA recall evidence

Device 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.

Z-0482-2026

October 06, 2025

Class II

Product summary

Firm
Olympus Corporation of the Americas
Event
Event 97733
Status
Ongoing
Classification
Class II
Quantity
48208 units
Official record key
device-enforcement:Z-0482-2026

Official wording

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.

Code information: 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

Distribution pattern: Worldwide distribution - US Nationwide and the countries of GU, and MP.

Derived failure modes

  • Sterility assurance

    reason.sterility_assurance · v1.0.0

    Sterility compromised