Olympus Corporation Of The Americas recalls Brand Name: Olympus Single Use Single Use Electrosurgical Snare SD-400 Product Name: S…

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.

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.

On October 6, 2025 URGENT: MEDICAL DEVICE RECALL letters were sent to customers. Actions to be taken: Examine your inventory and quarantine any affected devices. Cease usage of the product immediately. Please contact customer service to request a return material authorization, a credit will be issued for any returned product. Please forward this notice to other users who may have the affected products if you have further distributed it. Olympus requests you to report any complaints, including holes in device packaging, to our Technical Assistance Center (TAC) at 1- 800-848-9024, option 1, and the FDA. Adverse events experienced with the use of this product may also be reported to the FDA s MedWatch Adverse Event Reporting program either online, by regular mail, or by fax. Olympus fully appreciates your prompt cooperation in addressing this situation. If you require additional information, please do not hesitate to contact me directly by phone at (647) 999-3203 or by e-mail Cynthia.Ow@Olympus.com.

• FDA enforcement recordOfficial FDA database entry for Z-0483-2026
• FDA 510(k) clearance · K172734The device's official FDA premarket clearance record
• FDA device classification · FDIOfficial FDA classification for this device type
• CFR regulation · 21 CFR 876.4300The federal regulation governing this device
• FDA recall announcementSearch FDA.gov for the official press announcement
• Find Olympus Corporation of the AmericasSearch for the manufacturer's official notice
• News coverageRecent reporting on this recall and manufacturer
• openFDA data recordThe raw JSON record this page is built from

Source: U.S. FDA openFDA device enforcement reports. This summary is informational and may lag or differ from the official record. Always verify against the FDA before acting.