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Baxter Healthcare Corporation

Baxter Healthcare Corporation Recalls

All product recalls associated with Baxter Healthcare Corporation.

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Recall Summary

Total Recalls

467

Past Year

Class I (Serious)

Most Recent

Oct 2025

Data from FDA, USDA, CPSC, and NHTSA public records. Recall counts vary by company size, industry, and reporting practices. Always check official sources for current information.

Showing 201–220 of 467 recalls

Baxter Healthcare Corporation: Spectrum IQ Infusion System with Dose IQ Safety Software,...

System errors were noted following changes the customers implemented to the configuration of their network and server systems. Gateway Server System performance anomalies resulted in excessive Spectrum IQ pump connectivity errors.

FDAJun 4, 2021Nationwide• Baxter Healthcare Corporation

Baxter Healthcare Corporation: Gambro Cartridge Blood Set, Product Code 101025 - Product...

There is a potential leak between the venous patient connector and patient's hemodialysis access.

FDAApr 14, 2021Nationwide• Baxter Healthcare Corporation

Baxter Healthcare Corporation: Spectrum IQ - Infusion Pump - Product Usage: intended to ...

Potentially defective component in the AC power adapter which may fail over time.

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FDA

Mar 19, 2021

Nationwide

• Baxter Healthcare Corporation

Baxter Healthcare Corporation: Preventative Maintenance Kits G5010007) and spare part ki...

Variability in the performance of the tubing in the Prismaflex Control Unit ARPS (Automatic Repositioning System) Pump Assembly, may lead to alarm situations during or after a system self-test.

FDAJan 28, 2021Nationwide• Baxter Healthcare Corporation

Baxter Healthcare Corporation: Prismaflex Control Unit - Product Usage: Used for Contin...

Variability in the performance of the tubing in the Prismaflex Control Unit ARPS (Automatic Repositioning System) Pump Assembly, may lead to alarm situations during or after a system self-test.

FDAJan 28, 2021Nationwide• Baxter Healthcare Corporation

Baxter Healthcare Corporation: The PrisMax System Version II Hemodialysis Delivery Syste...

Variability in the performance of the tubing in the ARPS (Automatic Repositioning System) Pump Assembly which may lead to alarm situations during system self-test and therapy. This tubing is normally replaced during annual preventative maintenance. Alarm Situations: During System Self-Test: Alarm code B1215 (ARPS Self-Test failure); During Therapy: B1273 (ARPS Leak), B1215 (ARPS Pressure self-test), B1116 (Return Pressure self-test Failure), B1539 (Access Pod Reposition Failure), B1541 (Effluent Pod Reposition Failure), B1540 (Effluent Filter Pod Reposition Failure). If an alarm occurs, it may lead to delay or interruption of therapy. In the event that therapy is terminated without returning blood to the patient, blood loss may occur.

FDAJan 7, 2021Nationwide• Baxter Healthcare Corporation