FDA recall, , Moderate risk
Spectrum IQ Infusion Pump
The Spectrum IQ Infusion Pump was released without full testing, including occlusion alarm testing.
Summary by Recall Canary from the FDA notice
What happened
Baxter Healthcare Corporation of Deerfield, Illinois, recalled the Spectrum IQ Infusion Pump, model 3570009, because the pumps were released without full testing being performed, including occlusion alarm testing. The recall began on January 13, 2026, and was added to the FDA's Enforcement Report on February 13, 2026. The product was distributed in the state of Ohio within the United States.
What to do
We don't have product-specific instructions for this recall. FDA's general advice for medical device recalls:
- A device recall doesn't always mean you must stop using it: it may need to be checked, adjusted or fixed.
- Talk to your health care provider before you stop using it.
Is yours affected?
Affected if its model number matches.
- Model number
- 3570009
Recall details
- Company began the recall
- Sold in
States: Ohio Countries: United States
- Company
- Baxter Healthcare CorporationDeerfield, Illinois
- Hazard
- Device defect
- Risk
Moderate risk
Using it may cause short-term health problems, or ones that treatment can reverse. Serious harm is unlikely.
FDA Class II recall · How risk is rated
- Event ID
- 98306
- Recall number
- Z-1368-2026
All recalls from Baxter Healthcare Corporation
Timeline
FDA's Enforcement Report is its public list of recalls; FDA adds a recall when it posts it and publishes the list weekly.
Company began the recall
Added to FDA's Enforcement Report · Classified by FDA
In FDA's weekly enforcement report
Listed on Recall Canary
Summary updated
