CLASS I ONGOING Device recall · Reported 23 Jul 2025 · FDA Enforcement Report

Baxter Sigma Spectrum Infusion Pump V6 recalled by Baxter Healthcare

Baxter Healthcare is recalling Baxter Sigma Spectrum Infusion Pump V6, distributed in 10 states. The recall was initiated on 20 Jun 2025 and the FDA has classified it as Class I.

Check your package

Lot, batch or date codesUDI-DI: 00085412091570; Serial Numbers: 765100 , 772744 , 789742 , 841197 , 867753 , 920606 , 1024015 770164 788724 , 793079 , 842498 , 918342 , 962810 , 1027523

Quantity recalled14 units

Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.

Recall details

Recall number: Z-2095-2025
FDA event ID: 97072
Recalling firm: Baxter Healthcare, Deerfield, IL
Classification: Class I
Status: Ongoing
Recall initiated: 20 Jun 2025
FDA classified: 17 Jul 2025
Reported: 23 Jul 2025
Type: Voluntary: Firm initiated
Customers notified by: Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit
Reason category: Device Malfunction
Device type: Infusion Pumps

Timeline

20 Jun 2025	Recall initiated by company
17 Jul 2025	Classified by FDA	+27 days
23 Jul 2025	Published in enforcement report	+6 days

Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.

Reason for recall

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

Device recalls are issued when a component, software or design fault could cause the device to fail or give wrong readings. Many are corrections applied in the field rather than physical returns.

Product as listed by the FDA

Baxter SIGMA Spectrum Infusion Pump V6, Model Number 35700BAX

Where it was distributed

US States: CA, FL, IL, KS, MI, MS, NY, OH, OK, and VA.

California Florida Illinois Kansas Michigan Mississippi New York Ohio Oklahoma Virginia

Questions about this recall

Why was it recalled?

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

Which lots are affected?

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

Where was it sold?

US States: CA, FL, IL, KS, MI, MS, NY, OH, OK, and VA.

What should I do if I have it?

Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.

What does Class I mean?

Class I is the most serious FDA recall category: there is a reasonable probability that using the product will cause serious health consequences or death.

Read the official FDA notice · Source record retrieved 26 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.

Other products in this recall event

1 other product · FDA event 97072

Reported	Class	Recall	Company	Reason	Where
23 Jul 2025	CLASS I	Baxter Sigma Spectrum Infusion Pump V8 recalled by Baxter Healthcare	Baxter Healthcare	Device Malfunction	10 states

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