Recall Z-1368-2026— Baxter Healthcare Corporation

Name: FDA recall Z-1368-2026
Creator: U.S. Food and Drug Administration
Published: 2026-01-13

Class II · Ongoing

Class II FDA medical device recall by Baxter Healthcare Corporation, initiated 2026-01-13. It names one FDA 510(k) clearance: K251636. Product: 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. Reason: Pumps were released without full testing being performed, including occlusion alarm testing..

Recalling firm: Baxter Healthcare Corporation
Classification: Class II
Status: Ongoing
Initiated: 2026-01-13
Firm location: Deerfield, IL, United States

510(k) clearances named in this recall

1 on FDA's record

K251636 — Spectrum IQ Infusion System with Dose IQ Safety Software (3570009)Baxter Healthcare Corporation·cleared 2025-07-28

K-numbers as listed on FDA's Recall Enterprise System record for this event (openFDA device/recall k_numbers). The recall may also cover devices cleared under other submissions not named here.

Product description

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

Reason for recall

Pumps were released without full testing being performed, including occlusion alarm testing.

Data sourced from openFDA. This site is unofficial and independent of the FDA.