Class I

Medical Device Recall: 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.

Olympus Corporation of the Americas · October 30, 2025

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.

Distribution

US-wide distribution

Quantity Affected

7803 units

Source: FDA (openFDA Device Enforcement)

Recall number: Z-0570-2026

Status: ongoing

SafeCheck provides drug interaction information from FDA-approved product labeling (openFDA). This is for informational purposes only and is not medical advice. Always consult your healthcare provider before making medication decisions.

Olympus Corporation of the Americas Medical Device Recall: 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. | SafeCheck