Olympus Corporation of the Americas recalls Brand Name: Single Use Ligating Device Product Name: Olympus HX-400U-30 Model/Catalog Number: HX-400U-30 Used with an O…

Recall date

October 30, 2025

Source

U.S. Food & Drug Administration (FDA) — enforcement report

Recall number

Z-0570-2026

FDA classification

Class I

Brand / firm

Olympus Corporation of the Americas

Sold / distributed

US-wide distribution

Why it was recalled

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.

Class I is the FDA’s most serious recall level: there is a reasonable probability that using this product will cause serious harm or death.

What was recalled

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.