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

Is Baxter Sigma Spectrum Infusion Pump V6 recalled?

Yes. Baxter Healthcare recalled Baxter Sigma Spectrum Infusion Pump V6 on 20 Jun 2025. The recall is Class I and its status is Ongoing. Recall number Z-2095-2025.

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

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9 Sep 2026Device	CLASS II	Baxter Novum IQ Syringe Pump, Loaner recalled by Baxter Healthcare	Baxter Healthcare	Device Malfunction	Nationwide
9 Sep 2026Device	CLASS II	Baxter Novum IQ Syringe Pump recalled by Baxter Healthcare	Baxter Healthcare	Device Malfunction	Nationwide
19 Aug 2026Device	CLASS I	Baxter Duo-Vent Solution Set and Male Luer Lock Adapter, Product recalled	Baxter Healthcare	Other	Nationwide
22 Jul 2026Device	CLASS II	Plum Solo Precision IV Pump, v1.0.3 recalled by ICU Medical	ICU Medical	Other	Nationwide
1 Jul 2026Device	CLASS II	Intera Oncology Intera 3000 Hepatic Artery Infusion Pump recalled	Boston Scientific	Packaging Defects	Nationwide