CLASS II ONGOING Device recall · Reported 3 Sep 2025 · FDA Enforcement Report
Spectrum IQ Infusion Pump recalled by Baxter Healthcare
Baxter Healthcare is recalling Spectrum IQ Infusion Pump, distributed in Arizona, Florida. The recall was initiated on 14 Jul 2025 and the FDA has classified it as Class II.
Check your package
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
Recall details
- Recall number
- Z-2415-2025
- FDA event ID
- 97335
- Recalling firm
- Baxter Healthcare, Deerfield, IL
- Classification
- Class II
- Status
- Ongoing
- Recall initiated
- 14 Jul 2025
- FDA classified
- 22 Aug 2025
- Reported
- 3 Sep 2025
- Type
- Voluntary: Firm initiated
- Customers notified by
- Telephone
- Reason category
- Device Malfunction
- Device type
- Infusion Pumps
Timeline
| 14 Jul 2025 | Recall initiated by company | |
| 22 Aug 2025 | Classified by FDA | +39 days |
| 3 Sep 2025 | Published in enforcement report | +12 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
Reason for recall
Baxter has identified that certain pumps have potentially been released with the grease applied to the cam and motor gears that will break down quickly. The breakdown of the grease will lead to the device having insufficient or ineffective grease applied to the cam, which could lead to premature wear of the mechanism assembly, resulting in excessive therapy.
Device recalls are issued when a component, software or design fault could cause the device to fail or give wrong readings. Many are corrections applied in the field rather than physical returns.
Product as listed by the FDA
Spectrum IQ Infusion Pump, Product Code 3570009
Where it was distributed
US distribution to states of: AZ, FL
Questions about this recall
Why was it recalled?
Baxter has identified that certain pumps have potentially been released with the grease applied to the cam and motor gears that will break down quickly. The breakdown of the grease will lead to the device having insufficient or ineffective grease applied to the cam, which could lead to premature wear of the mechanism assembly, resulting in excessive therapy.
Which lots are affected?
UDI-DI: 00085412610900; Serial Numbers: 3815255 3815261 3815265 3815266 3815267 3815271
Where was it sold?
US distribution to states of: AZ, FL
What should I do if I have it?
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
What does Class II mean?
Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.
Read the official FDA notice · Source record retrieved 26 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.
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