United StatesThe affected product is the Olympus Single Use Ligating Device (Product Name HX-400U-30, Model/Catalog Number HX-400U-30, UDI 04953170368615), used with an Olympus endoscope to deliver a nylon loop snare; all non‑expired lots distributed in the United States are included. It was recalled because the ligation loop may not release or detach as expected during use, which can cause the loop to become unintentionally fixed around patient anatomy.
What's being 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.
Recalling firm: Olympus Corporation of the Americas, Center Valley, PA, United States.
How to identify it
Model/Catalog Number: HX-400U-30; UDI: 04953170368615; All Lots which have not expired;
The 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.
What to do
Don't stop taking a prescribed medicine without talking to your doctor or pharmacist first. For other products, stop using them and ask the pharmacist, seller or maker what to do.
The notice doesn't give instructions for consumers, so this is general advice for health & beauty recalls. Check the official notice for the details.
Where it was sold
US-wide distribution
The official notice
This page is a summary of the notice published by U.S. Food and Drug Administration (enforcement reports), collected from U.S. Food and Drug Administration (enforcement reports). Check the original before you act on it.
Read the official notice (opens in a new tab)