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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

193

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 161–180 of 193 recalls

Baxter Healthcare Corporation: 3,65 m Extension Set with Luer-lock Connector

Certain Peritoneal Dialysis product codes do not have FDA regulatory clearance and were distributed within the United States in error.

Moderate

FDAApr 21, 2022Nationwide• Baxter Healthcare Corporation

Baxter Healthcare Corporation: 15 Liters Drain Bag

Certain Peritoneal Dialysis product codes do not have FDA regulatory clearance and were distributed within the United States in error.

Moderate

FDAApr 21, 2022Nationwide• Baxter Healthcare Corporation

Baxter Healthcare Corporation: 5 Prong Manifold Set (with Luer Connectors)

Certain Peritoneal Dialysis product codes do not have FDA regulatory clearance and were distributed within the United States in error.

Moderate

FDA

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Apr 21, 2022

Nationwide

• Baxter Healthcare Corporation

Baxter Healthcare Corporation: Effluent Sample Bag

Certain Peritoneal Dialysis product codes do not have FDA regulatory clearance and were distributed within the United States in error.

Moderate

FDAApr 21, 2022Nationwide• Baxter Healthcare Corporation

Baxter Healthcare Corporation: APD Drain Manifold

Certain Peritoneal Dialysis product codes do not have FDA regulatory clearance and were distributed within the United States in error.

Moderate

FDAApr 21, 2022Nationwide• Baxter Healthcare Corporation

Baxter Healthcare Corporation: Locking Cap for PD Catheter Adapter

Certain Peritoneal Dialysis product codes do not have FDA regulatory clearance and were distributed within the United States in error.

Moderate

FDAApr 21, 2022Nationwide• Baxter Healthcare Corporation

Baxter Healthcare Corporation: Flo-Thru Intraluminal Shunt. Used in coronary artery or p...

There is a potential for foreign matter.

Moderate

FDAApr 1, 2022Nationwide• Baxter Healthcare Corporation

Baxter Healthcare Corporation: PrisMax System, Product Code 955626

This correction is due to software anomalies occurring during use. If the operator initiates therapy by entering a value other than the default value for the patient Gain/Loss Limit or the Return Pressure Drop Limit (RDL) and uses the Same Patient function, the PrisMax System will return the patient Gain/Loss Limit or the RDL to the default value, rather than the non-default value entered at the initiation of treatment. The PrisMax System interface will display the original values once treatment is restarted but does not have an alert to inform the user of the change. The RDL value will be returned to the original value immediately upon selecting the Same Patient function. The Gain/Loss Limit value will be returned to the original value when the patient weight and/or hematocrit is changed during treatment.

Moderate

FDAMar 15, 2022Nationwide• Baxter Healthcare Corporation

Baxter Healthcare Corporation: PrisMax System, Product Codes: a) 955558, b) 955627, c) ...

Moderate

FDAMar 15, 2022Nationwide• Baxter Healthcare Corporation

Baxter Healthcare Corporation: Baxter DISCPAC Syringe Tip Caps, Self-Righting, Luer Sli...

Product is mislabeled as self-righting Luer slip tip caps, yellow.

Moderate

FDAFeb 25, 2022Nationwide• Baxter Healthcare Corporation

Baxter Healthcare Corporation: MiniCap Extended Life PD Transfer Set Product Codes: 5C44...

Devices distributed lacked regulatory clearance.

Moderate

FDAFeb 25, 2022Nationwide• Baxter Healthcare Corporation

Baxter Healthcare Corporation: Liko Universal Twinbar 670 QRH, an accessory that can be ...

An incorrect center bolt was used in the assembly of the product which could result in a patient fall during use.

Moderate

FDAFeb 21, 2022Nationwide• Baxter Healthcare Corporation

Baxter Healthcare Corporation: Compella Therapy Air Supply Unit

Potential damage to the power cord may cause the power conductors to be exposed, thereby creating a risk of shock from the power mains.

High

FDAFeb 14, 2022Nationwide• Baxter Healthcare Corporation

Baxter Healthcare Corporation: Compella Bariatric Bed System

Potential damage to the power cord may cause the power conductors to be exposed, thereby creating a risk of shock from the power mains.

High

FDAFeb 14, 2022Nationwide• Baxter Healthcare Corporation

Baxter Healthcare Corporation: Baxter CAPD System Transfer Set (CAPD MiniCap Transfer Se...

Cleaning products, containing, but not limited to, hydrogen peroxide, bleach, alcohol, or antiseptic agents and solvent, such as those containing acetone, toluene, xylene, or cyclohexanone may cause damage, such as leaking or cracking, to the MiniCap Extended Life PD transfer sets.

Moderate

FDAJan 7, 2022Nationwide• Baxter Healthcare Corporation

Baxter Healthcare Corporation: Baxter MiniCap Extended Life PD Transfer Set (Easy-Lock),...

Moderate

FDAJan 7, 2022Nationwide• Baxter Healthcare Corporation

Baxter Healthcare Corporation: Baxter Equipo de transferencia para DP MiniCap de vida ut...

Moderate

FDAJan 7, 2022Nationwide• Baxter Healthcare Corporation

Baxter Healthcare Corporation: Baxter Spectrum IQ Infusion Pumps, Product code 3570009.

There is the potential for reduced or non-delivery of medication, in some cases without alerting the user via pump alarm. This may occur as a result of incorrect administration set setup and/or incomplete resolution of upstream occlusion alarms when using Spectrum V8 and Spectrum IQ infusion pumps.

Moderate

FDADec 29, 2021Nationwide• Baxter Healthcare Corporation

Baxter Healthcare Corporation: Baxter SIGMA Spectrum Infusion Pump with Master Drug Libr...

Moderate

FDADec 29, 2021Nationwide• Baxter Healthcare Corporation

Baxter Healthcare Corporation: Hemodialysis Delivery System, Software Version 2.x.

If the operator initiates therapy with a saved prescription profile and makes a change to the prescription after a disposable filter change using the Same Patient button, the system may suggest values from the original prescription profile, rather than the current prescription.

Moderate

FDASep 29, 2021Nationwide• Baxter Healthcare Corporation