Serious health hazard — there is a reasonable probability that use of or exposure to this product will cause serious adverse health consequences or death.
SIGMA Spectrum Infusion Pump Recalled by Baxter Healthcare Corporation Due to A medical device correction is being issued for...
What You Should Do
Stop using this product immediately. Do not consume, use, or distribute it.
Return the product to the place of purchase for a full refund. If you have questions, contact Baxter Healthcare Corporation directly.
Affected Products
SIGMA Spectrum Infusion Pump, Product Code 35700BAX2
Quantity: 3306 units
Why Was This Recalled?
A medical device correction is being issued for SIGMA Spectrum Infusion System (V8 Platform) and Spectrum IQ Infusion System with Dose IQ Safety Software infusion pumps due to an increase in reported false upstream occlusion alarms following upgrades to software versions v8.01.01 and v9.02.01.
Where Was This Sold?
This product was distributed nationwide across all 50 states.
About Baxter Healthcare Corporation
Baxter Healthcare Corporation has 401 total recalls tracked by RecallDetector.
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Data sourced from the FDA (Device). Last updated March 26, 2026. View original report