Recall archive / 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. Source coverage and dates.
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
What the recall classes mean. 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.