FDA recall Z-0482-2026

Olympus Corporation of the Americas · Class II · 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.

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.

Distribution

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

Key facts

Status
Ongoing
Initiation date
2025-10-06
Report date
2025-11-19
Voluntary/Mandated
Voluntary: Firm initiated
Location
Center Valley, PA, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0482-2026