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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 41–60 of 467 recalls

TruSystem 7500 Mobile 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.

FDAFeb 25, 2025Nationwide• Baxter Healthcare Corporation

Progressa Bed Surfaces (Baxter) – Air Bladder Movement (2025)

The air bladders inside the mattress may move out of position when the head of the bed is elevated, causing a dip in the mattress.

FDAFeb 25, 2025Nationwide• Baxter Healthcare Corporation

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.

FDA

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Page 3 of 24Next

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.

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.

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.

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.

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.

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.

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.

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.

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.

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.

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.

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.

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.

FDAOct 21, 2024Nationwide• Baxter Healthcare Corporation

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

FDAOct 16, 2024Nationwide• Baxter Healthcare Corporation

Welch Allyn Q-Stress System (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.

FDAOct 11, 2024Nationwide• Baxter Healthcare Corporation

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

FDAOct 11, 2024Nationwide• Baxter Healthcare Corporation