Olympus Corporation of the Americas has recalled 7,803 units of the Single Use Ligating Device (model HX-400U-30). This device is used with an Olympus endoscope to deliver a nylon loop snare during medical procedures. The recall was issued because the ligation loop may fail to release or detach as expected, potentially leaving the loop unintentionally fixed around a patient's internal anatomy.
If the ligation loop does not detach, it can become stuck around patient anatomy, which may lead to tissue damage or require additional surgical procedures to remove the device.
Corrective action or return
All Lots which have not expired;
If you or a family member were harmed by this recalled product, you may have legal rights. Consider consulting a consumer protection attorney to understand your options for compensation.
This is general information, not legal advice. Go Backs is not a law firm and does not provide legal services.
AI-Enhanced Content: The summary, action steps, and risk assessment on this page were generated by AI from official government recall data to improve readability. This is not legal or medical advice. Always refer to the official agency sources below for authoritative information.
Sources: FDA iRES · FDA Press Release (1) · FDA Press Release (2) · Raw API Response
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