---
title: "EndoVive Replacement Button Kit w/ ENFIT 28F 2.8 CM, Outer Box UPN M00509500 ... — FDA record Z-1153-2024 | Is It on Recall"
description: "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 defect"
url: https://isitonrecall.com/recall/fda-device-z-1153-2024-endovive-replacement-button-kit-w-enfit-28f-2-8-cm-outer-box-upn-m00509500-or-m00509510/
updated: 2026-10-01
site: "Is It on Recall"
language: en
---

[Recall archive](https://isitonrecall.com/archives/) / FDA device enforcement

# EndoVive Replacement Button Kit w/ ENFIT 28F 2.8 CM, Outer Box UPN M00509500 or M00509510. — FDA record Z-1153-2024

Reported ongoing

Status as reported in the agency record. FDA warns that enforcement status may not track the current recall lifecycle; check the current official notice.

Source date Dec 19, 2023. Retrieved Oct 1, 2026. Last updated Oct 1, 2026.

Archive changed Oct 1, 2026. USDA FSIS records are unavailable; [check FSIS directly](https://www.fsis.usda.gov/recalls). [Source coverage and dates](https://isitonrecall.com/sources/).

## What the record says

- **Product**: EndoVive Replacement Button Kit w/ ENFIT 28F 2.8 CM, Outer Box UPN M00509500 or M00509510.
- **Reason**: 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.
- **Classification**: Class II
- **Recalling firm**: Boston Scientific Corporation
- **Quantity**: 0 US; 74 OUS
- **Agency-reported status**: Ongoing
- **Source record identifier**: Z-1153-2024

[Open the official record](https://api.fda.gov/device/enforcement.json?search=recall_number%3A%22Z-1153-2024%22)

[What the recall classes mean](https://isitonrecall.com/guides/recall-classes/). Classification is an agency assessment, not individual medical advice.

## Lot and product identifiers

| Label field | Details supplied by the agency |
| --- | --- |
| Lot, code or applicability | UPN M00509500, GTIN (UDI-DI) 08714729902713, Lot 31073152; UPN M00509510, GTIN (UDI-DI) 08714729902720, Lots 31221751, 31761882, 32409573. |

Match all identifying details in the current notice. A brand name alone is not enough.

## Distribution

International distribution to the country of Japan only.

No US distribution state could be established from this record. Check the official notice.

## Dates in the source

- **Report date**: Feb 28, 2024
- **Recall initiation date**: Dec 19, 2023
- **Center classification date**: Feb 16, 2024

FDA company pages use the listing date; enforcement records use initiation dates; CPSC uses recall date; NHTSA uses report-received date. These dates are not interchangeable.

## What to do next

Read the official notice for the action that applies to your exact product.

[Read the current instructions](https://api.fda.gov/device/enforcement.json?search=recall_number%3A%22Z-1153-2024%22)

## Related records

[Medical devices records](https://isitonrecall.com/category/medical-devices/) [Boston Scientific Corporation records](https://isitonrecall.com/brand/boston-scientific-corporation/)