Potential health hazard — use of or exposure to this product may cause temporary or medically reversible adverse health consequences.
EndoVive Replacement Button Kit w/ ENFIT 28F 2.8 CM Recalled by Boston Scientific Corporation Due to Affected batches of the kit contain Stoma Measuring...
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 Boston Scientific Corporation directly.
Affected Products
EndoVive Replacement Button Kit w/ ENFIT 28F 2.8 CM, Outer Box UPN M00509500 or M00509510.
Quantity: 0 US; 74 OUS
Why Was This Recalled?
Affected batches of the kit contain Stoma Measuring Devices sized to measure for an 18/24F replacement button, but are labeled as being for a 28F. Use of defective product may lead to undersizing the button, which may cause embedding with erosion into the gastric wall, tissue necrosis, infection, sepsis, and associate sequelae.
Where Was This Sold?
International distribution to the country of Japan only.
About Boston Scientific Corporation
Boston Scientific Corporation has 601 total recalls tracked by RecallDetector.
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Data sourced from the FDA (Device). Last updated March 26, 2026. View original report