Data Foundry

Medical device recalls 2025

Spectrum IQ Infusion Pump — Class II medical device recall Z-2415-2025

Ongoing recall by Baxter Healthcare Corporation, reported 2025-09-03, distributed in AZ, FL. Baxter has identified that certain pumps have potentially been released with the grease applied to the cam and

Recall numberZ-2415-2025
Product typeMedical device
ClassificationClass II
StatusOngoing
Voluntary or mandatedVoluntary
Recalling firmBaxter Healthcare Corporation, Deerfield, IL, United States
Recall initiated2025-07-14
Classified2025-08-22
Reported by FDA2025-09-03
DistributedAZ, FL
Quantity6 units
Reason classesdevice malfunction
UPC / GTIN / UDI-DI00085412610900
Serial numbers3815255, 3815261, 3815265, 3815266, 3815267, 3815271

Product

Spectrum IQ Infusion Pump, Product Code 3570009

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.

Machine access

This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/Z-2415-2025. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.

Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.