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Lower risk Medical device recall · FDA · Published July 7, 2021

Baxter Dose IQ Software Recall: Drug ID Mismatch Risk

Baxter recalls Dose IQ Safety Software (version 9.0.x) for Spectrum IQ pumps due to drug identifier mismatch risk. Affected users should contact Baxter for remedy.

🇺🇸 FDA recall #Z-2165-2021Medical deviceBaxter Healthcare ›
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Recalling firmBaxter Healthcare Corporation1 Baxter Pkwy · Deerfield, IL 60015-4625
✎ GovInfoNow plain-language explainer

Baxter is recalling Dose IQ Safety Software used with Spectrum IQ Infusion Pumps because a software defect causes mismatched drug identifiers. This could lead to incorrect medication dosing if the software fails to properly link drug names to the pump's internal library. Read more at govinfonow.com/recall/62237-baxter-dose-iq-software-recall-drug-id-mismatch-risk.

Source Summary by GovInfoNow · govinfonow.com/recall/62237-baxter-dose-iq-software-recall-drug-id-mismatch-risk · Updated August 19, 2026 · FDA enforcement record: FDA #Z-2165-2021

Cite this page

“Baxter Dose IQ Software Recall: Drug ID Mismatch Risk.” GovInfoNow, updated August 19, 2026. https://govinfonow.com/recall/62237-baxter-dose-iq-software-recall-drug-id-mismatch-risk. Based on FDA recall #Z-2165-2021 (https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-2165-2021%22&limit=1).

The FDA announced on July 7, 2021, that Baxter Healthcare Corporation voluntarily recalled Dose IQ Safety Software used with the Spectrum IQ Infusion Pump due to a software defect. The hazard involves a mismatch between linked drug identifiers in the user interface and the binary drug library loaded onto the pump.

How to tell if you have it

  • Brand: Baxter Healthcare
  • Product: Dose IQ Safety Software used with Spectrum IQ Infusion Pump
  • Software version: All libraries initially created with version 9.0.x
  • Quantity: 61 units

The hazard

The software defect creates a mismatch between linked drug identifiers (IDs) in the Dose IQ user interface and the binary drug library loaded onto the Spectrum IQ pump. The recall is classified as Class I.

Context

GovInfoNow's records show Baxter Healthcare Corporation has had 187 other recalls on record since September 2, 2015. Recent recalls include a PRO+ MRS SURFACE FOR VERSACARE mattress recalled on August 18, 2026, for labeling errors and a 0.9% Sodium Chloride Injection recall on August 17, 2026, for fiberglass particulates. Other recent recalls of similar products include a Fresenius Kabi Ivenix Infusion System Software Recall (November 14, 2025) and a Boston Scientific Intera 3000 Hepatic Artery Pump Recall (May 11, 2026).

How to tell if you have this one

Check if your Spectrum IQ Infusion Pump uses Dose IQ Safety Software with version 9.0.x. This software was initially created with version 9.0.x and is used with the Spectrum IQ pump.

  • Brand
    Baxter Healthcare
  • Category
    Medical device
Based on the official FDA remedy

What to do — step by step

  1. Contact Baxter

    Reach out to Baxter Healthcare Corporation for specific instructions on how to address the software issue.

Where it went and when

Where it was distributed

Distributed nationwide.

Alaska: yesAKMaine: yesMEVermont: yesVTNew Hampshire: yesNHWashington: yesWAIdaho: yesIDMontana: yesMTNorth Dakota: yesNDMinnesota: yesMNIllinois: yesILWisconsin: yesWIMichigan: yesMINew York: yesNYRhode Island: yesRIMassachusetts: yesMAOregon: yesORNevada: yesNVWyoming: yesWYSouth Dakota: yesSDIowa: yesIAIndiana: yesINOhio: yesOHPennsylvania: yesPANew Jersey: yesNJConnecticut: yesCTCalifornia: yesCAUtah: yesUTColorado: yesCONebraska: yesNEMissouri: yesMOKentucky: yesKYWest Virginia: yesWVVirginia: yesVAMaryland: yesMDDelaware: yesDEArizona: yesAZNew Mexico: yesNMKansas: yesKSArkansas: yesARTennessee: yesTNNorth Carolina: yesNCSouth Carolina: yesSCDistrict of Columbia: yesDCOklahoma: yesOKLouisiana: yesLAMississippi: yesMSAlabama: yesALGeorgia: yesGAHawaii: yesHITexas: yesTXFlorida: yesFL

FDA distribution: “US Nationwide Distribution.” States read from FDA’s own wording; “not listed” means the notice does not name it.

Distributed nationwide.

Recall timeline

FDA terminated this recall 3 years after the firm started it.

1. Firm started the recall: Jul 7, 202112. FDA classified it Class I: Aug 11, 202123. Published in FDA’s Enforcement Report: Aug 18, 202134. FDA terminated the recall: Jun 20, 2024420212024
  1. Firm started the recall
  2. FDA classified it Class I
  3. Published in FDA’s Enforcement Report
  4. FDA terminated the recall

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

✎ GovInfoNow

Questions people ask

Is this software dangerous?

The software defect could cause mismatched drug identifiers, potentially leading to incorrect medication dosing, but the recall indicates it's not an immediate safety hazard requiring immediate stop-use.

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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-2165-2021 (July 7, 2021) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for Z-2165-2021 to see it in context.
  • Plain-language summary written by qwen3:4b on August 19, 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