Baxter Healthcare Recalls Spectrum IQ Infusion Pumps Due to Missing Safety Testing

Source: FDA · Ohio, United States

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Baxter Healthcare Corporation has voluntarily recalled five Spectrum IQ Infusion Pumps in Ohio after discovering the units were distributed without required occlusion alarm testing.

What this FDA recall tells you, and what most readers miss

This notice was issued by FDA on March 3, 2026 and geographically references Ohio, United States. Its severity classification of "high" signals how the issuing agency weighs the risk of harm if no action is taken — "critical" and "high" tier alerts typically carry direct consumer actions, while "medium" and "low" tend toward informational guidance or monitoring advisories. The category it belongs to — FDA Recalls — determines the regulatory framework behind it, which shapes what remedies (refunds, replacements, recalls, evacuations) are available to affected individuals and who holds statutory responsibility for enforcement.

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What Happened

Baxter Healthcare Corporation has initiated a voluntary Class II recall of specific Spectrum IQ Infusion Pumps. The recall was triggered because these units were released into distribution without undergoing full safety testing, specifically missing the required occlusion alarm testing. This failure to test means the devices may not properly alert healthcare providers if an infusion line becomes blocked.

Which Products Are Affected

This recall is limited to five (5) units distributed in the state of Ohio. The affected products are identified by the following details:

  • Brand Name: Spectrum IQ
  • Product Name: Infusion Pump
  • Model/Catalog Number: 3570009
  • GTIN: 00085412610900
  • Serial Numbers: 3815663, 3823468, 3824743, 3825234, and 3825599
  • Recall Number: Z-1368-2026

What You Should Do

Healthcare facilities and providers in Ohio should immediately check their inventory for the serial numbers listed above. Baxter Healthcare Corporation initiated the notification process via telephone. Owners of the affected devices should contact the firm at 1 Baxter Pkwy, Deerfield, IL 60015, to arrange for the return or proper testing of the units.

Why This Matters

Occlusion alarms are critical safety features that ensure patients receive the correct dosage of medication without interruption. If a pump fails to detect a blockage, it could lead to a delay in treatment or the delivery of an incorrect dose, posing a serious risk to patient health.

Source

Information provided by the FDA. Recall Event ID: 98306.

Original source: FDA Official Notice ↗

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Frequently Asked Questions

Common questions about this FDA recall.

What is this FDA recall about?
Baxter Healthcare Corporation has voluntarily recalled five Spectrum IQ Infusion Pumps in Ohio after discovering the units were distributed without required occlusion alarm testing.
Which agency issued this alert?
This alert was issued by FDA. The original notice is available at the source link at the bottom of this article.
How severe is this alert?
This alert is classified as "high" severity. Take precautions and monitor for updates.
What area is affected?
This alert affects Ohio, United States. Check with FDA for the most current geographic scope.
Where can I find more FDA Recalls updates?
Browse the full FDA Recalls feed on Areazine at areazine.com/recalls/fda/ for the latest updates from FDA and other agencies.