Class I — UrgentReported 2025-12-03

Brand Name: Single Use Ligating Device Product Name: Olympus HX-400U-30 Model/Catalog Number: HX-400U-30 Used with an Olympus endoscope to deliver a nylon loop snare.

Recalled by Olympus Corporation of the Americas

Reason for Recall

Potential that the ligation loop was unable to release or detach as expected during use, causing the loop to become unintentionally fixed around patient anatomy.

Recall Number

Z-0570-2026

Classification

Class I

Status

Ongoing