Recall archive / FDA device enforcement
Baxter SIGMA Spectrum Infusion Pump V8, Model Number 35700BAX2 — FDA record Z-2096-2025
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 Jun 20, 2025. 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
- Baxter SIGMA Spectrum Infusion Pump V8, Model Number 35700BAX2
- Reason
- Certain Spectrum infusion pumps may have an incorrect version of software.
- Classification
- Class I
- Recalling firm
- Baxter Healthcare Corporation
- Quantity
- 28 units
- Agency-reported status
- Ongoing
- Source record identifier
- Z-2096-2025
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: 00085412498683; Serial Numbers: 2006307 , 2052091 , 2093765 , 2095360 , 2104302 , 2119236 , 2141815 , 2025925 , 2067699 , 2094483 , 2095541 , 2105238 , 2119436 , 2143406 , 2034297 , 2074097 , 2094580 , 2096351 , 2105769 , 2135482 , 2143684 , 2051591 , 2090658 , 2095202 , 2096856 , 2118940 , 2137976 , 2156201 |
Match all identifying details in the current notice. A brand name alone is not enough.
Distribution
US States: CA, FL, IL, KS, MI, MS, NY, OH, OK, and VA.
States below are derived from the distribution text, including nationwide wording. They are not inferred from the firm's address.
Dates in the source
- Report date
- Jul 23, 2025
- Recall initiation date
- Jun 20, 2025
- Center classification date
- Jul 17, 2025
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.