Olympus Corporation of the Americas is recalling 66,382 Single Use Electrosurgical Snares (models SD-400U-10 and SD-400U-15). These devices are intended for use with endoscopes to remove or cauterize polyps and tissue from within the gastrointestinal tract. The recall was issued because small holes may form in the device pouches during packaging or transportation, which compromises the sterile barrier of the instruments.
A compromise in sterility means the devices may no longer be free from bacteria or other microorganisms. Using a non-sterile device during an endoscopic procedure can introduce contaminants into a patient's body, potentially leading to serious infections.
Quantity: 48,208 units
Quantity: 18,174 units
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.
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Sources: FDA iRES · Raw API Response
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