Brand Name: Single Use Ligating Device Product Name: Olympus HX-400U-30 Model/Catalog Number: H...
FDA Recall #Z-0570-2026 — Class I — October 30, 2025
Product Description
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.
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.
Recalling Firm
Olympus Corporation of the Americas — Center Valley, PA
Classification
Class I — Reasonable probability of serious adverse health consequences or death.
Product Type
Devices
Product Quantity
7803 units
Distribution
US-wide distribution
Code Information
Model/Catalog Number: HX-400U-30; UDI: 04953170368615; All Lots which have not expired;
Status
Ongoing
Voluntary / Mandated
Voluntary: Firm initiated