FDA-Device2026-02-25Class IIPROCESSING DEFECT
Baxter Spectrum IQ infusion pump recalled for incomplete safety testing
What this means
Baxter Healthcare released 5 Spectrum IQ infusion pumps (model 3570009) without completing required safety tests, including tests of the occlusion alarm that alerts users to blockages. The pumps were distributed in Ohio. No injuries have been reported.
- If you use or operate a Baxter Spectrum IQ infusion pump, check the serial number: 3815663, 3823468, 3824743, 3825234, or 3825599
- If your pump matches, contact Baxter Healthcare immediately for instructions
- Do not discard the pump without guidance from Baxter or your healthcare provider
The agency's original wording
Hazard
Pumps were released without full testing being performed, including occlusion alarm testing.
Intended for
Adults
Illnesses reported
None reported
Sold states
States: Ohio Countries: United States
Affected count
5
Manufactured in
1 Baxter Pkwy, Deerfield, IL, United States
Products
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
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1368-2026More Baxter recalls
- FDA-Device2026-09-09Baxter Novum IQ Syringe Pump recalled for software issue during multi-syringe infusion
- FDA-Device2026-09-09Baxter Novum IQ Syringe Pump recalled for software issue during multi-syringe infusion
- FDA-Drug2026-09-09Baxter Clindamycin Phosphate injection recalled for manufacturing compliance deviations
- FDA-Drug2026-09-09Baxter Vancomycin Injection recalled for CGMP manufacturing deviations
- FDA-Drug2026-09-09Baxter Clindamycin Injection recalled for manufacturing quality deviations
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