EndoVive Replacement Button Kit w/ ENFIT 28F 2 — Class II medical device recall Z-1153-2024
Ongoing recall by Boston Scientific Corporation, reported 2024-02-28. Affected batches of the kit contain Stoma Measuring Devices sized to measure for an 18/24F replacement button,
| Recall number | Z-1153-2024 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Ongoing |
| Voluntary or mandated | Voluntary |
| Recalling firm | Boston Scientific Corporation, Marlborough, MA, United States |
| Recall initiated | 2023-12-19 |
| Classified | 2024-02-16 |
| Reported by FDA | 2024-02-28 |
| Countries outside the US | JP |
| Reason classes | labeling |
| UPC / GTIN / UDI-DI | 08714729902713, 08714729902720 |
| Lot numbers | 31073152, 31221751, 31761882, 32409573, M00509510 |
Product
EndoVive Replacement Button Kit w/ ENFIT 28F 2.8 CM, Outer Box UPN M00509500 or M00509510.
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.
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/Z-1153-2024. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.