device recall
saveOlympus Corporation of the Americas device recall (Cls I)
October 30, 2025updated 3mo ago
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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. — 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. — Status: Ongoing
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