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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 41–60 of 193 recalls

TruSystem 7500 Stationary Column (Baxter) – Software Control Fault (2025)

There is a software issue which causes the upper back section to not be operable/adjustable when the "emergency mode" function is enabled.

Moderate

FDAFeb 25, 2025Nationwide• Baxter Healthcare Corporation

TruSystem 7500 Floor Column (Baxter) – Software Control Fault (2025)

There is a software issue which causes the upper back section to not be operable/adjustable when the "emergency mode" function is enabled.

Moderate

FDAFeb 25, 2025Nationwide• Baxter Healthcare Corporation

TruSystem 7500 Hybrid (Baxter) – Software Control Fault (2025)

There is a software issue which causes the upper back section to not be operable/adjustable when the "emergency mode" function is enabled.

Moderate

FDA

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Feb 25, 2025

Nationwide

• Baxter Healthcare Corporation

TruSystem 7500 Hybrid (Baxter) – Software Control Fault (2025)

There is a software issue which causes the upper back section to not be operable/adjustable when the "emergency mode" function is enabled.

Moderate

FDAFeb 25, 2025Nationwide• Baxter Healthcare Corporation

TruSystem 7500 Hybrid Plus (Baxter) – Software Control Fault (2025)

There is a software issue which causes the upper back section to not be operable/adjustable when the "emergency mode" function is enabled.

Moderate

FDAFeb 25, 2025Nationwide• Baxter Healthcare Corporation

Spectrum IQ Infusion System (Baxter) – mounting screw issue (2025)

There is the potential for missing motor mounting screws, which may have occurred during the servicing process.

Moderate

FDAFeb 5, 2025Nationwide• Baxter Healthcare Corporation

Sigma Spectrum Infusion System (Baxter) – mounting screw issue (2025)

There is the potential for missing motor mounting screws, which may have occurred during the servicing process.

Moderate

FDAFeb 5, 2025Nationwide• Baxter Healthcare Corporation

Life 2000 Ventilation System (Baxter) – Battery Charger Alarm (2024)

There is an issue with the ventilator battery charger that could lead to an audible and visual alarm. If the alarm is engaged, the ventilator becomes inoperable.

Moderate

FDADec 20, 2024Nationwide• Baxter Healthcare Corporation

Baxter Solution Set (Baxter) – Inverted Side Clamps (2024)

Specific lots of Solution Sets with Duo-Vent Spike have the potential for inverted side clamps causing the tubing to be unusable.

Moderate

FDADec 20, 2024Nationwide• Baxter Healthcare Corporation

Life2000 Ventilation System (Baxter) – Battery Charger Alarm (2024)

There is an issue with the ventilator battery charger that could lead to an audible and visual alarm. If the alarm is engaged, the ventilator becomes inoperable.

Moderate

FDADec 20, 2024Nationwide• Baxter Healthcare Corporation

Clearlink System Solution Set (Baxter) – Inverted Side Clamps (2024)

Specific lots of Solution Sets with Duo-Vent Spike have the potential for inverted side clamps causing the tubing to be unusable.

Moderate

FDADec 20, 2024Nationwide• Baxter Healthcare Corporation

Life2000 Ventilation System (Baxter) – Battery Charger Alarm (2024)

There is an issue with the ventilator battery charger that could lead to an audible and visual alarm. If the alarm is engaged, the ventilator becomes inoperable.

Moderate

FDADec 20, 2024Nationwide• Baxter Healthcare Corporation

Continu-Flo Solution Set (Baxter) – Inverted Side Clamps (2024)

Specific lots of Solution Sets with Duo-Vent Spike have the potential for inverted side clamps causing the tubing to be unusable.

Moderate

FDADec 20, 2024Nationwide• Baxter Healthcare Corporation

Baxter SIGMA Spectrum Pump (Baxter) – Incomplete Testing (2024)

Devices were identified as released after repair without full testing being performed, which includes flow testing.

Moderate

FDANov 19, 2024Nationwide• Baxter Healthcare Corporation

Regadenoson Injection (Baxter) – Missing Label (2024)

Labeling: Missing Label

Class IIModerate

FDAOct 30, 2024Nationwide• Baxter Healthcare Corporation

Baxter MiniCap PD Transfer Set (Baxter) – connector separation risk (2024)

There has been an increase in the number of complaints related to the separation of the female connector from the main body of the transfer set.

Moderate

FDAOct 23, 2024Nationwide• Baxter Healthcare Corporation

Baxter MiniCap PD Transfer Set (Baxter) – Chemical Risk (2024)

Baxter is aware of several recalls by other manufacturers related to the potential risk of exposure to non-dioxin-like (NDL) polychlorinated biphenyl acids (PCBAs) and NDL polychlorinated biphenyls (PCBs) when using certain peritoneal dialysis and hemodialysis devices.

Moderate

FDAOct 21, 2024Nationwide• Baxter Healthcare Corporation

Baxter AK 98 Dialysis Machine (Baxter) – Chemical Risk (2024)

Moderate

FDAOct 16, 2024Nationwide• Baxter Healthcare Corporation

Welch Allyn Cardiology Suite (Baxter) – File ID Duplication (2024)

There is the potential for exam files being assigned duplicate Unique Identifiers (UIDs),. If the system receiving the DICOM file (e.g., Picture Archiving and Communication System (PACS)) relies solely on the UID to accept exams, this could lead to a mismatch of the patients identification with their physiological data.

Moderate

FDAOct 11, 2024Nationwide• Baxter Healthcare Corporation

Welch Allyn HScribe Holter System (Baxter) – File ID Duplication (2024)

Moderate

FDAOct 11, 2024Nationwide• Baxter Healthcare Corporation