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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

260

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 121–140 of 260 recalls

Dianeal PD-2 Dialysis Solution (Baxter) – sterility concern (2023)

Lack of Assurance of Sterility: Potential presence of leaks originating from the Luer component.

Class IIModerate

FDAAug 11, 2023Nationwide• Baxter Healthcare Corporation

Dianeal Low Calcium Solution (Baxter) – sterility concern (2023)

Lack of Assurance of Sterility: Potential presence of leaks originating from the Luer component.

Class IIModerate

FDAAug 11, 2023Nationwide• Baxter Healthcare Corporation

Baxter Healthcare Corporation: Baxter Epiphany Cardio Server E3 ECG Management System Se...

Epiphany, now a Baxter Healthcare company, is issuing an Urgent Medical Device Correction for the Cardio Server E3 ECG Management System software listed below due to a report of the caliper tool becoming non-responsive, preventing the caliper function from being used temporarily on software versions v6.1.x, v6.2.x, and v7.0.x of the E3 user interface.

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FDAAug 10, 2023Nationwide• Baxter Healthcare Corporation

Baxter Healthcare Corporation: Welch Allyn Connex Spot Monitor

Product is being recalled due to the improper placement of a copper tape on the back of the liquid-crystal display.

FDAAug 10, 2023Nationwide• Baxter Healthcare Corporation

Baxter Healthcare Corporation: GEM FLOW COUPLER Monitor, PN 5156-00000-011

An issue was identified where the LCD monitor display may not indicate the correct active channel. The issue occurs when the monitor is turned on using battery power, and channel B was selected as the last active channel prior to powering down.

FDAJun 19, 2023Nationwide• Baxter Healthcare Corporation

Baxter Healthcare Corporation: The Spectrum IQ Infusion System with Dose IQ Safety Softw...

A medical device correction is being issued for SIGMA Spectrum Infusion System (V8 Platform) and Spectrum IQ Infusion System with Dose IQ Safety Software infusion pumps due to an increase in reported false upstream occlusion alarms following upgrades to software versions v8.01.01 and v9.02.01.

FDAJun 15, 2023Nationwide• Baxter Healthcare Corporation

Baxter Healthcare Corporation: SIGMA Spectrum Infusion Pump, Product Code 35700BAX2

FDAJun 15, 2023Nationwide• Baxter Healthcare Corporation

Baxter Healthcare Corporation: NaviCare Patient Safety V3.9.200 to 3.9.600, used with th...

Baxter identified a potential risk where the "safety" monitoring and "bed exit" monitoring features may enter a permanent state of alert suppression. In this state, a caregiver may not be alerted remotely when assigned patient protocols (bed exit, siderail position, brakes off, height of bed changes, head of bed angle, and/or turn reminders) are turned off.

FDAMay 19, 2023Nationwide• Baxter Healthcare Corporation

Baxter Healthcare Corporation: Voalte Patient Safety, Part Number 4.0, V4.0.000 to 4.0.4...

FDAMay 19, 2023Nationwide• Baxter Healthcare Corporation

Baxter Healthcare Corporation: Allen Advance Chest Support with Pad

Potential for the device to crack where the Chest Base Prone support attaches to the carbon fiber operating room (OR) table rail.

FDAMay 18, 2023Nationwide• Baxter Healthcare Corporation

Baxter Healthcare Corporation: Hill-Rom pro+ mattress, product codes (REF): a) 20877002...

There is a potential for mattress cover damage (delamination) which may result in fluid absorption in the mattress (fluid ingress).

FDAMar 31, 2023Nationwide• Baxter Healthcare Corporation

Baxter Healthcare Corporation: GEM NEUROTUBE, Absorbable Woven Polyglycolic Acid Mesh Tu...

The product is brittle and potentially crumbling upon handling or when being removed from its package.

FDAMar 27, 2023Nationwide• Baxter Healthcare Corporation

Baxter Healthcare Corporation: ExactaMed Oral Dispenser - 20 mL Clear Pharmacy Pack, REF...

ExataMed 20 mL oral dispenser component of the Clear Pharmacy Pack may have particulate matter.

FDAMar 20, 2023Nationwide• Baxter Healthcare Corporation

Dianeal Low Calcium Dialysis Solution (Baxter Healthcare) – Sterility Concern (2023)

Lack of Assurance of Sterility: Potential presence of leaks originating from the Luer component.

Class IIModerate

FDAMar 15, 2023Nationwide• Baxter Healthcare Corporation

Dianeal PD-2 Dialysis Solution (Baxter Healthcare) – Sterility Concern (2023)

Lack of Assurance of Sterility: Potential presence of leaks originating from the Luer component.

Class IIModerate

FDAMar 15, 2023Nationwide• Baxter Healthcare Corporation

Baxter Healthcare Corporation: Automated Peritoneal Dialysis System. Used for automatic...

The electrical safety testing was not properly performed on the impacted devices and additional testing is required

FDAFeb 22, 2023AL, AZ, AR +7 more• Baxter Healthcare Corporation

Baxter Healthcare Corporation: Baxter MiniCap Disconnect Cap with Povidone-Iodine Soluti...

MiniCap Disconnect Cap with Povidone-Iodine are packaged in foil pouches, which may have been incorrectly sealed, i.e., the pouches may have open or weak seals. This could lead to exposure to air, resulting in insufficient iodine/dry sponge inside the MiniCap, which could lead to the potential for inadequate disinfectant.

FDAFeb 1, 2023Nationwide• Baxter Healthcare Corporation

Baxter Healthcare Corporation: Life2000 Ventilator System, a) REF BT-20-0002, b) REF BT-...

There is the potential for patient desaturation events to occur under certain scenarios when the Life2000 ventilation system is connected with an oxygen concentrator.

FDAJan 25, 2023Nationwide• Baxter Healthcare Corporation

Baxter Healthcare Corporation: Life2000 Ventilator , REF MS-01-0118, ventilatory support...

There is the potential for patient desaturation events to occur under certain scenarios when the Life2000 ventilation system is connected with an oxygen concentrator.

FDAJan 25, 2023Nationwide• Baxter Healthcare Corporation

Baxter Healthcare Corporation: Life2000 Ventilator PKG, Hospital, a) REF BT20007, b) REF...

There is the potential for patient desaturation events to occur under certain scenarios when the Life2000 ventilation system is connected with an oxygen concentrator.

FDAJan 25, 2023Nationwide• Baxter Healthcare Corporation