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: 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.

Code information: Model/Catalog Number: HX-400U-30; UDI: 04953170368615; All Lots which have not expired;

Distribution pattern: US-wide distribution