Boston Scientific Corporation: Medical Device Recall in 2024 - (Recall #: Z-1153-2024)

Updated on March 25, 2026.

See the recall detail below. You can also see other recalls from the same firm in 2024.

Data Source: FDA.

Product Description:

EndoVive Replacement Button Kit w/ ENFIT 28F 2.8 CM, Outer Box UPN M00509500 or M00509510.

Product Classification:

Class II

Date Initiated: December 19, 2023

Date Posted: February 28, 2024

Recall Number: Z-1153-2024

Event ID: 93794

Reason for Recall:

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.

Status: Ongoing

Product Quantity: 0 US; 74 OUS

Code Information:

UPN M00509500, GTIN (UDI-DI) 08714729902713, Lot 31073152; UPN M00509510, GTIN (UDI-DI) 08714729902720, Lots 31221751, 31761882, 32409573.

Distribution Pattern:

International distribution to the country of Japan only.

Voluntary or Mandated:

Voluntary: Firm initiated