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FDAOctober 30, 2025device

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.

Official recall recorded by the U.S. Food & Drug Administration.

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

FDA enforcement status: Ongoing

Brands named

olympus

UPCs

04953170368615

Recall history

Other federal recalls tied to the same brand — a factual pattern, straight from the source data.

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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. — Recall Details · AllClear