Serious health hazard — there is a reasonable probability that use of or exposure to this product will cause serious adverse health consequences or death.
Brand Name: Single Use Ligating Device Product Name: Olympus HX-400U-30 Recalled by Olympus Corporation of the Americas Due to Potential that the ligation loop was unable to...
What You Should Do
Stop using this product immediately. Do not consume, use, or distribute it.
Return the product to the place of purchase for a full refund. If you have questions, contact Olympus Corporation of the Americas directly.
Affected Products
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.
Quantity: 7803 units
Why Was This Recalled?
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.
Where Was This Sold?
US-wide distribution
About Olympus Corporation of the Americas
Olympus Corporation of the Americas has 378 total recalls tracked by RecallDetector.
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Data sourced from the FDA (Device). Last updated March 26, 2026. View original report