Recall Z-0482-2026— Olympus Corporation of the Americas

Name: FDA recall Z-0482-2026
Creator: U.S. Food and Drug Administration
Published: 2025-10-06

Class II · Ongoing

Class II FDA medical device recall by Olympus Corporation of the Americas, initiated 2025-10-06. It names one FDA 510(k) clearance: K172734. 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: 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..

Recalling firm: Olympus Corporation of the Americas
Classification: Class II
Status: Ongoing
Initiated: 2025-10-06
Firm location: Center Valley, PA, United States

510(k) clearances named in this recall

1 on FDA's record

K172734 — Single Use Electrosurgical Snare SD-400Olympus Medical Systems Corp.·cleared 2017-12-07

K-numbers as listed on FDA's Recall Enterprise System record for this event (openFDA device/recall k_numbers). The recall may also cover devices cleared under other submissions not named here.

Product description

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.

Data sourced from openFDA. This site is unofficial and independent of the FDA.