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FDA · Medical devicesClass I

Baxter Healthcare Corporation medical device recall: Baxter SIGMA Spectrum Infusion Pump V6

Software problems

Key facts

Agency
U.S. Food and Drug Administration (FDA)
Program
Medical devices
Classification
Class I
Status
Ongoing
Event ID
97072
Recall initiated
Jun 20, 2025
Classified by FDA
Jul 17, 2025
Posted in Enforcement Report
Jul 23, 2025
Recalling firm
Baxter Healthcare Corporation
Firm location
Deerfield, IL, United States
Initiated by
Voluntary: Firm initiated
Firm notified customers by
Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit
Products in this event
2

What to do

Compare the product, lot or serial numbers below with what you have. If you use a prescription drug or medical device in this recall, talk to your pharmacist or health care provider before you stop using it, and follow the firm's instructions.

View the official FDA record ↗

Reason for recall

Certain Spectrum infusion pumps may have an incorrect version of software.

What the classification means

  • Class I: FDA's most serious category: there is a reasonable probability that using or being exposed to the product will cause serious health problems or death.

About this recall

The firm started this recall on Jun 20, 2025. FDA classified it 27 days later, on Jul 17, 2025. This recall event covers 2 separate products, each with its own FDA recall number. Distribution reported by FDA: US States: CA, FL, IL, KS, MI, MS, NY, OH, OK, and VA. Baxter Healthcare Corporation has 279 recalls in our records.

Recalled products (2)

  • Z-2095-2025 Class I Ongoing

    Baxter SIGMA Spectrum Infusion Pump V6, Model Number 35700BAX

    Codes / lots: UDI-DI: 00085412091570; Serial Numbers: 765100 , 772744 , 789742 , 841197 , 867753 , 920606 , 1024015 770164 788724 , 793079 , 842498 , 918342 , 962810 , 1027523

    Quantity: 14 units

  • Z-2096-2025 Class I Ongoing

    Baxter SIGMA Spectrum Infusion Pump V8, Model Number 35700BAX2

    Codes / lots: 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

    Quantity: 28 units

Source and freshness

Source
U.S. Food and Drug Administration (FDA) Enforcement Report, via the openFDA device enforcement dataset
Official notice
FDA Enforcement Report, event 97072
Raw record
openFDA API (JSON)
Dataset last updated by FDA
Nov 3, 2026
Imported by RecallRadar
Nov 4, 2026

Enforcement Report entries describe recalls FDA has classified. They are not always the same as a company press release. If something here differs from FDA's record, FDA's record is correct — please tell us.

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