Medical Device Recall: 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 instrum
Olympus Corporation of the Americas · October 6, 2025
Reason for Recall
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.
Product Description
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.
Distribution
Worldwide distribution - US Nationwide and the countries of GU, and MP.
States Affected
NATIONWIDE
Quantity Affected
18174 units
Source: FDA (openFDA Device Enforcement)
Recall number: Z-0483-2026
Status: ongoing
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