Medical device recalls Moderate risk

Baxter Healthcare Corporation recalls Brand Name: Spectrum IQ Product Name: Infusion Pump Model/Catalog Number: 3570009 Software Version: N/A Product Descrip…

Recall date
January 13, 2026
Source
U.S. Food & Drug Administration (FDA) — enforcement report
Recall number
Z-1368-2026
FDA classification
Class II
Brand / firm
Baxter Healthcare Corporation
Sold / distributed
States: Ohio Countries: United States

Why it was recalled

Pumps were released without full testing being performed, including occlusion alarm testing.

Class II means using this product may cause temporary or medically reversible health problems; the chance of serious harm is remote.

What was recalled

Brand Name: Spectrum IQ Product Name: Infusion Pump Model/Catalog Number: 3570009 Software Version: N/A Product Description: Infusion Pump, one unit per carton Component: N/A

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