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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

47

Class I (Serious)

1

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 1–20 of 193 recalls

Welch Allyn INF BAG (Baxter) – Bladder Size Mismatch (2025)

Replacement bladder kit for the Welch Allyn two-piece reusable blood pressure cuff may contain a Large Adult size bladder rather than a Thigh size bladder in the replacement kits.

FDAOct 28, 2025Nationwide• Baxter Healthcare Corporation

Oral Probe (Baxter) – Temperature Reading Error (2025)

Affected oral/axillary probes were inadvertently programmed with the rectal probe configuration. Affected probes will potentially display a lower temperature than the true value, which may lead to a delay in managing fever-related symptoms or infection.

FDASep 17, 2025Nationwide• Baxter Healthcare Corporation

CLEARLINK Extension Set (Baxter) – IV Set Leak (2025)

IV sets may leak.

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Aug 29, 2025

Nationwide

• Baxter Healthcare Corporation

CONTINU-FLO Solution Set (Baxter) – IV Set Leak (2025)

IV sets may leak.

FDAAug 29, 2025Nationwide• Baxter Healthcare Corporation

CLEARLINK System Solution Set (Baxter) – IV Set Leak (2025)

IV sets may leak.

FDAAug 29, 2025Nationwide• Baxter Healthcare Corporation

CLEARLINK Paclitaxel Set (Baxter) – IV Set Leak (2025)

IV sets may leak.

FDAAug 29, 2025Nationwide• Baxter Healthcare Corporation

CLEARLINK Extension Set (Baxter) – Potential Leakage (2025)

IV sets may leak.

FDAAug 29, 2025Nationwide• Baxter Healthcare Corporation

CLEARLINK NON-DEHP Solution Set (Baxter) – IV Set Leak (2025)

IV sets may leak.

FDAAug 29, 2025Nationwide• Baxter Healthcare Corporation

CLEARLINK CONTINU-FLO Set (Baxter) – IV Set Leak (2025)

IV sets may leak.

FDAAug 29, 2025Nationwide• Baxter Healthcare Corporation

Acetaminophen Injection (Baxter Healthcare) - Discoloration (2025)

Discoloration

Class IIModerate

FDAAug 20, 2025Nationwide• Baxter Healthcare Corporation

Continu-Flo Solution Set (Baxter) – customer reports (2025)

Baxter Healthcare Corporation is issuing an Urgent Medical Device Recall for one lot of Continu-Flo solution sets listed below due to customer reports of tubing separation.

FDAAug 8, 2025Nationwide• Baxter Healthcare Corporation

Novum IQ Syringe Pump (Baxter) – device correction (2025)

Baxter Healthcare Corporation is issuing an Urgent Medical Device Correction for the Novum IQ Large Volume Pump (LVP) and Novum IQ Syringe Pump (SP) due to software anomalies that may result in a blank Run screen (LVP and SP) and/or false motor movement system error (SP only).

FDAAug 4, 2025PR• Baxter Healthcare Corporation

Novum IQ Large Volume Pump (Baxter) – device correction (2025)

Baxter Healthcare Corporation is issuing an Urgent Medical Device Correction for the Novum IQ Large Volume Pump (LVP) and Novum IQ Syringe Pump (SP) due to software anomalies that may result in a blank Run screen (LVP and SP) and/or false motor movement system error (SP only).

FDAAug 4, 2025PR• Baxter Healthcare Corporation

Spectrum IQ Infusion Pump (Baxter) – Grease Breakdown (2025)

Baxter has identified that certain pumps have potentially been released with the grease applied to the cam and motor gears that will break down quickly. The breakdown of the grease will lead to the device having insufficient or ineffective grease applied to the cam, which could lead to premature wear of the mechanism assembly, resulting in excessive therapy.

FDAJul 14, 2025AZ, FL• Baxter Healthcare Corporation

Baxter Novum IQ Pump (Baxter) – Infusion Transition Risk (2025)

Baxter is issuing an Urgent Medical Device Correction for the Novum IQ large volume pump (LVP) due to the potential for underinfusion when transitioning from a flow rate to a higher flow rate that is more than double. (e.g., rate change or bolus). The level of underinfusion is variable based on the current infusion rate, the duration the pump has been running at this flow rate, and the magnitude of the rate change. The longer the duration the pump has been running at the current infusion rate and the larger the magnitude of the rate change, the larger the underinfusion that would be experienced. Additionally, Baxter has identified an increase in customer reports of over and underinfusion potentially due to set misloading. Failure to properly load the tubing into the pump channel may result in the pump infusing at a rate higher or lower than programmed. Consistent with the instructions for use, customers should ensure that: 1) The door is fully open before loading the set. 2) The tubing is taut and loaded without slack in the pumping channel.

FDAJul 14, 2025Nationwide• Baxter Healthcare Corporation

SIGMA Spectrum Pump (Baxter) – Software Version (2025)

Certain Spectrum infusion pumps may have an incorrect version of software.

FDAJun 20, 2025CA, FL, IL +7 more• Baxter Healthcare Corporation

Hillrom Q-Link 13 Component (Baxter Healthcare) – False Attachment Risk (2025)

The Q-link 13 could allow for an improper attachment (false latching) of the Quick-Release Hook used on Sling Bars and other accessories. This could result in a critical injury from a patient fall as the false latched component may initially bear weight but can loosen from the Q-link resulting in a detachment and drop.

FDAMay 30, 2025Nationwide• Baxter Healthcare Corporation

Hillrom LikoScale (Baxter) – Attachment Hook Risk (2025)

The Q-link 13 could allow for an improper attachment (false latching) of the Quick-Release Hook used on Sling Bars and other accessories. This could result in a critical injury from a patient fall as the false latched component may initially bear weight but can loosen from the Q-link resulting in a detachment and drop.

FDAMay 30, 2025Nationwide• Baxter Healthcare Corporation

Baxter Novum IQ Syringe Pump (Baxter) – Syringe Detection Issue (2025)

Baxter has identified a design issue which may cause the pump to detect the presence of a syringe flange when no syringe is loaded. When this issue occurs, the pumps 'user interface becomes stuck on the "Remove Syringe" screen when an infusion is complete, and the syringe is unloaded. A System Error 21502 (Flange Sensor Failure) may occur. Please note this issue only affects a subset of Novum IQ syringe pumps manufactured or repaired after July 4, 2023.

FDAMay 12, 2025Nationwide• Baxter Healthcare Corporation

Welch Allyn Battery (Baxter) – Short Circuit Risk (2025)

The replacement rechargeable batteries inserted into the Welch Allyn PocketScope handles have the potential to cause a short circuit in the handle, which can lead to exposure to excessive heat and user burns.

FDAMay 9, 2025Nationwide• Baxter Healthcare Corporation