Recall archive / FDA device enforcement
medex TranStar Neonatal Monitoring Kit 10/EA, Product Code REF MX9530T — FDA record Z-0196-2025
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 Sep 24, 2024. 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
- medex TranStar Neonatal Monitoring Kit 10/EA, Product Code REF MX9530T
- Reason
- Due to a manufacturing defect, users may experience inaccurate pressure monitoring, an interruption in pressure monitoring, or an inability to zero the device due to either a leak within the TranStar Disposable Pressure Transducer or from a defect within the TranStar Disposable Pressure Transducer chip.
- Classification
- Class II
- Recalling firm
- Smiths Medical ASD, Inc.
- Quantity
- 2580 units
- Agency-reported status
- Ongoing
- Source record identifier
- Z-0196-2025
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 | UDI/DI 50351688503280 (case), 10351688503282 (pouch), Lot Numbers: 4282765, 4307302, 4309198, 4311461, 4316668, 4328487, 4350011, 4366881 |
Match all identifying details in the current notice. A brand name alone is not enough.
Distribution
Worldwide distribution.
No US distribution state could be established from this record. Check the official notice.
Dates in the source
- Report date
- Oct 30, 2024
- Recall initiation date
- Sep 24, 2024
- Center classification date
- Oct 23, 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.