Boston Scientific Corporation EndoVive Replacement Button Kit w/ ENFIT 28F 2.8 CM, Outer Box UPN M00509500 or M00509510. Recall
Hazard assessment based on recall description.
This AI-generated summary is provided for general informational purposes only and is derived from publicly available recall notices. It supplements but does not replace official agency classifications or safety instructions.
Check Your Product
According to the U.S. Food and Drug Administration (FDA)
Product
EndoVive Replacement Button Kit w/ ENFIT 28F 2.8 CM, Outer Box UPN M00509500 or M00509510.
Brand
Boston Scientific Corporation
Lot Codes / Batch Numbers
UPN M00509500, GTIN (UDI-DI) 08714729902713, Lot 31073152, UPN M00509510, GTIN (UDI-DI) 08714729902720, Lots 31221751, 31761882, 32409573.
Products Sold
UPN M00509500, GTIN (UDI-DI) 08714729902713, Lot 31073152; UPN M00509510, GTIN (UDI-DI) 08714729902720, Lots 31221751, 31761882, 32409573.
Boston Scientific Corporation is recalling EndoVive Replacement Button Kit w/ ENFIT 28F 2.8 CM, Outer Box UPN M00509500 or M00509510. due to 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. Based on FDA medical device recall database.
Summary derived from FDA notice
Reason for Recall
As stated by FDA
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.
Recommended Action
Per FDA guidance
On December 19, 2024, the firm notified affected customers via URGENT MEDICAL DEVICE PRODUCT REMOVAL letters. Customers were instructed to cease further distribution or use of any remaining affected product. Distributors should forward the notice to their customers to ensure the recall is carried out to the end-user level. Customers were instructed to discontinue use and segregate affected product. Customers will receive a Return Goods Authorization (RGA) number after completing and returning their Reply Verification Tracking Form (RVTF). Customers will receive credit for returned affected product. Reach out to your local Boston Scientific representative with any questions.
Verify this information on the official source
For complete details and official instructions, check the U.S. Food and Drug Administration (FDA) directly.
View official FDA recall noticePage updated: Jan 10, 2026