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Unrated Medical device recall · FDA · Published June 20, 2025

Baxter Spectrum Infusion Pump V6 Software Issue Recall

Baxter recalls Spectrum Infusion Pump V6 Model 35700BAX with incorrect software version. Affected units may have safety risks; contact Baxter for details.

🇺🇸 FDA recall #Z-2095-2025Medical deviceBaxter ›
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Contact the company

Recalling firmBaxter Healthcare Corporation1 Baxter Pkwy · Deerfield, IL 60015-4625
✎ GovInfoNow plain-language explainer

What happened, in plain English

Baxter is recalling certain Spectrum Infusion Pump V6 models (35700BAX) due to a potential software issue. This could affect patient safety during medical treatments. Read more at govinfonow.com/recall/51992-baxter-spectrum-infusion-pump-v6-software-issue-recall.

Source Summary by GovInfoNow · govinfonow.com/recall/51992-baxter-spectrum-infusion-pump-v6-software-issue-recall · Updated August 18, 2026 · FDA enforcement record: FDA #Z-2095-2025

Cite this page

“Baxter Spectrum Infusion Pump V6 Software Issue Recall.” GovInfoNow, updated August 18, 2026. https://govinfonow.com/recall/51992-baxter-spectrum-infusion-pump-v6-software-issue-recall. Based on FDA recall #Z-2095-2025 (https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-2095-2025%22&limit=1).

Why it’s dangerous

The pumps may have an incorrect software version that could lead to improper medication delivery. This might cause treatment errors or safety issues during medical procedures.

Who’s affected

Patients using these infusion pumps for medical treatments are affected. Healthcare providers and caregivers who use the pumps are most at risk.

How to tell if you have this one

Check for the model number 35700BAX on the pump. Affected units have specific serial numbers listed in the recall notice.

  • Brand
    Baxter
  • Category
    Medical device
FDA recall event · 2 products

All 2 products in this recall

FDA lists each product line separately under one recall event. Check your product description, lot or code numbers against each row. Every row shares the hazard and remedy on this page.

  • Classification
    Class I
  • Status
    Ongoing
  • Distribution
    US States: CA, FL, IL, KS, MI, MS, NY, OH, OK, and VA.
Recall numberProduct, codes & lotsQuantity
Z-2095-2025Baxter SIGMA Spectrum Infusion Pump V6, Model Number 35700BAX; UDI-DI: 00085412091570; Serial Numbers: 765100 , 772744 , 789742 , 841197 , 867753 , 920606 , 1024015 770164 788724 , 793079 , 842498 , 918342 , 962810 , 102752314 units
Z-2096-2025Baxter SIGMA Spectrum Infusion Pump V8, Model Number 35700BAX2; 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 , 215620128 units
Based on the official FDA remedy

What to do — step by step

  1. Check Pump Model

    Look for the model number 35700BAX on the pump's label.

  2. Contact Baxter

    Reach out to Baxter Healthcare Corporation for further instructions on the recall.

Where it went and when

Where it was distributed

Distributed in 10 states.

Alaska: not listedAKMaine: not listedMEVermont: not listedVTNew Hampshire: not listedNHWashington: not listedWAIdaho: not listedIDMontana: not listedMTNorth Dakota: not listedNDMinnesota: not listedMNIllinois: yesILWisconsin: not listedWIMichigan: yesMINew York: yesNYRhode Island: not listedRIMassachusetts: not listedMAOregon: not listedORNevada: not listedNVWyoming: not listedWYSouth Dakota: not listedSDIowa: not listedIAIndiana: not listedINOhio: yesOHPennsylvania: not listedPANew Jersey: not listedNJConnecticut: not listedCTCalifornia: yesCAUtah: not listedUTColorado: not listedCONebraska: not listedNEMissouri: not listedMOKentucky: not listedKYWest Virginia: not listedWVVirginia: yesVAMaryland: not listedMDDelaware: not listedDEArizona: not listedAZNew Mexico: not listedNMKansas: yesKSArkansas: not listedARTennessee: not listedTNNorth Carolina: not listedNCSouth Carolina: not listedSCDistrict of Columbia: not listedDCOklahoma: yesOKLouisiana: not listedLAMississippi: yesMSAlabama: not listedALGeorgia: not listedGAHawaii: not listedHITexas: not listedTXFlorida: yesFL

FDA distribution: “US States: CA, FL, IL, KS, MI, MS, NY, OH, OK, and VA.” States read from FDA’s own wording; “not listed” means the notice does not name it.

States: California, Florida, Illinois, Kansas, Michigan, Mississippi, New York, Ohio, Oklahoma, Virginia.

Recall timeline

FDA published this recall 33 days after the firm started it.

1. Firm started the recall: Jun 20, 202512. FDA classified it Class I: Jul 17, 202523. Published in FDA’s Enforcement Report: Jul 23, 202532025
  1. Firm started the recall
  2. FDA classified it Class I
  3. Published in FDA’s Enforcement Report

Dates from the agency record only; steps without a date are left out.

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Where this comes from

The facts (hazard, remedy, dates, manufacturer) are pulled from the official FDA recall record. The plain-language summary and step-by-step checklist are written by GovInfoNow to make the official notice easier to act on — they don’t replace it.

  • Official source: FDA Recall #Z-2095-2025 (June 20, 2025) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for Z-2095-2025 to see it in context.
  • Plain-language summary written by qwen3:4b on August 18, 2026, from the official record above. Not reviewed by a person — if it conflicts with the FDA notice, the notice is correct. Report an error on this page.
  • GovInfoNow is an independent service and is not a government agency. We republish official FDA recall data; we don’t issue, amend or administer recalls.
GovInfoNow is an independent guide. We are not FDA or any government agency. Always confirm details with the official recall.Data: CPSC · FDA · NHTSA · USDA