Boston Scientific Corporation has recalled 74 units of the EndoVive Replacement Button Kit (28F 2.8 CM) because the kits contain the wrong size stoma measuring device. While the kits are labeled for a 28F size, the measuring tools inside are actually sized for smaller 18/24F buttons. This defect was identified in products distributed internationally to Japan and involves specific lot numbers including 31073152, 31221751, 31761882, and 32409573. Consumers should contact their healthcare provider or the manufacturer immediately for instructions on how to handle the affected medical kits.
Using the incorrect measuring device can lead a clinician to select a button that is too small for the patient. An undersized button may cause the device to become embedded in the gastric wall, leading to tissue death (necrosis), severe infection, erosion, and sepsis.
Contact healthcare provider or manufacturer for instructions.
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 · Raw API Response
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