FDA Device recall Z-2415-2025
Spectrum IQ Infusion Pump, Product Code 3570009
- FDA Device
- Class II
- ongoing
- Published 2025-09-03
On 2025-09-03 the FDA classified a Class II recall of Spectrum IQ Infusion Pump, Product Code 3570009 by Baxter Healthcare, citing 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 greas….
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-2415-2025 |
| Classification | Class II |
| Status | ongoing |
| Initiated | 2025-07-14 |
| Published | 2025-09-03 |
| Last updated | 2026-09-13 11:57 UTC |
| Company | Baxter Healthcare |
| Distribution | AZ, FL |
Product
Spectrum IQ Infusion Pump, Product Code 3570009
Reason
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.
Identifiers
| code_info | UDI-DI: 00085412610900; Serial Numbers: 3815255 3815261 3815265 3815266 3815267 3815271 |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:57 UTC. Current status: ongoing.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-2415-2025%22
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