Olympus Corporation of the Americas: Brand Name: Single Use Ligating Device Product Name:

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

Medical DevicesSource: FDA (press release) · Date: 2025-12-18

The text below is copied from the official FDA (press release) record. If anything differs, the official notice is correct.

Company / brand: Olympus Corporation of the Americas
Product: 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 / hazard: 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.
Classification: Class I
Status: Ongoing
Distribution / sold at: US-wide distribution
Recall initiated: 2025-10-30
Product type: Medical Devices,
Code info: Model/Catalog Number: HX-400U-30; UDI: 04953170368615; All Lots which have not expired;
Product quantity: 7803 units
Voluntary mandated: Voluntary: Firm initiated
City: Center Valley
State: PA
Country: United States
Event id: 97731
Enforcement url: https://www.accessdata.fda.gov/scripts/ires/index.cfm?Event=97731
Enforcement id: fda-device-Z-0570-2026
Announced product: Single use ligating device