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Baxter Healthcare Recalls
556 recalls on record · June 20, 2012 to August 19, 2026 · Drugs, Medical Devices
Recalls by year
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Count of recall notices naming this brand, by the year the recall was announced. A quiet year is not proof of a safe year.
October 1, 2025Medical DevicesFDA
Baxter Healthcare Corporation recalls Baster Continu-Flo Solution Set, Non-Vented, 2 Clearlink Luer Activated Valves, Backcheck Valve. 10 drops/mL. 112" (2.8
Hazard: 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.
September 10, 2025Medical DevicesFDA
Baxter Healthcare Corporation recalls Novum IQ Syringe Pump, Product Code 40700BAX, infusion pump
Hazard: 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).
September 10, 2025Medical DevicesFDA
Baxter Healthcare Corporation recalls Novum IQ Syringe Pump, Product Code 40800BAXUS, infusion pump
Hazard: 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).
September 10, 2025Medical DevicesFDA
Baxter Healthcare Corporation recalls Novum IQ LVP (Large Volume Pump), Product Code 40700BAXUS, infusion pump
Hazard: 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).
September 3, 2025Medical DevicesFDA
Baxter Healthcare Corporation recalls Spectrum IQ Infusion Pump, Product Code 3570009
Hazard: 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.
September 3, 2025DrugsFDA
Baxter Healthcare Corporation recalls Acetaminophen Injection 1000 mg/100 mL (10 mg/mL), packaged in 100 mL Viaflo container, Rx only, Baxter Healthcare Corpo
Hazard: Discoloration
August 20, 2025Medical DevicesFDA
Baxter Healthcare Corporation recalls Baxter Novum IQ Large Volume Pump, Product Code REF 40700BAXUS
Hazard: 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.
July 23, 2025Medical DevicesFDA
Baxter Healthcare Corporation recalls Baxter SIGMA Spectrum Infusion Pump V8, Model Number 35700BAX2
Hazard: Certain Spectrum infusion pumps may have an incorrect version of software.
July 23, 2025Medical DevicesFDA
Baxter Healthcare Corporation recalls Baxter SIGMA Spectrum Infusion Pump V6, Model Number 35700BAX
Hazard: Certain Spectrum infusion pumps may have an incorrect version of software.
July 16, 2025Medical DevicesFDA
Baxter Healthcare Corporation recalls Hillrom LikoScale component, Product Code 3156232, used with the following adapter kits for patient lifts: 1) LikoSc
Hazard: 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.
July 16, 2025Medical DevicesFDA
Baxter Healthcare Corporation recalls Hillrom Q-Link 13 component, Product Code 3156509, used with the following Mobile Patient Lifts: 1) Uno 102 EE Mobile
Hazard: 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.
June 18, 2025Medical DevicesFDA
Baxter Healthcare Corporation recalls Baxter Novum IQ Syringe Pump, product code 40800BAXUS,
Hazard: 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.
June 18, 2025Medical DevicesFDA
Baxter Healthcare Corporation recalls 2.5 V replacement rechargeable batteries for Hillrom WELCH ALLYN PocketScope handles, Product Code 72600
Hazard: 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.
June 4, 2025Medical DevicesFDA
Baxter Healthcare Corporation recalls Affinity 4 Birthing Bed, Product Codes P3700E100429, P3700E100432, P3700E100433, P3700E100434, P3700E100435, P3700E10043
Hazard: There is a potential for improper crimps on the signal wires of the actuators which could result in a loss of ability to lower the bed or the foot section of the bed.
May 28, 2025Medical DevicesFDA
Baxter Healthcare Corporation recalls Baxter Novum IQ LVP INFUSION SYSTEM, REF 40700BAXUS
Hazard: There is a potential for the Novum IQ LVP due to the potential for underinfusion following use of the "standby mode" feature or if the device is powered off with the set loaded.
May 21, 2025Medical DevicesFDA
Baxter Healthcare Corporation recalls Welch Allyn Life2000 Compressor, Product Codes: 1) BT-80-0004; 2) BT-80-0004A; 3) BT-80-0008; 4) BT-80-0008A;
Hazard: A cybersecurity vulnerability was discovered through internal testing.
May 21, 2025Medical DevicesFDA
Baxter Healthcare Corporation recalls Welch Allyn Life2000 Ventilation system, Product Codes: 1) BT-20-0002; 2) BT-20-0002A; 3) BT-20-0002AP; 4) BT20
Hazard: A cybersecurity vulnerability was discovered through internal testing.
April 23, 2025Medical DevicesFDA
Baxter Healthcare Corporation recalls Welch Allyn 2-Piece Reusable Blood Pressure Cuff Kits labeled as: 1. WELCH ALLYN 2-Piece Reusable Blood Pressure Cuff
Hazard: Undeclared natural rubber band within the packaging of certain configurations of reusable blood pressure cuffs.
April 23, 2025Medical DevicesFDA
Baxter Healthcare Corporation recalls Welch Allyn DuraShock Aneroid Gauge Sets with a Reusable Blood Pressure Cuff labeled as: 1) WELCH ALLYN DURASHOCK Ane
Hazard: Undeclared natural rubber band within the packaging of certain configurations of reusable blood pressure cuffs.
April 23, 2025Medical DevicesFDA
Baxter Healthcare Corporation recalls Welch Allyn Green Series 777 Wall System, Product Code/Part Numbers: 1) 77791-2MP2X; 2) 77791-2MP2XL; 3) 77791-2M
Hazard: Undeclared natural rubber band within the packaging of certain configurations of reusable blood pressure cuffs.
April 23, 2025Medical DevicesFDA
Baxter Healthcare Corporation recalls Welch Allyn Spot Vital Signs 4400 Device, Product Code/Part Numbers: 1) 44WT-2; 2) 44WT-3; 3) 44WT-4; 4) 44WT-6
Hazard: Undeclared natural rubber band within the packaging of certain configurations of reusable blood pressure cuffs.
April 23, 2025Medical DevicesFDA
Baxter Healthcare Corporation recalls Welch Allyn Connex Vital Signs Monitor, Product Code/Part Numbers: 1) ) Product Code/Part # 67MXTP-B-ECG3A; 2) ) Pr
Hazard: Undeclared natural rubber band within the packaging of certain configurations of reusable blood pressure cuffs.
April 23, 2025Medical DevicesFDA
Baxter Healthcare Corporation recalls Welch Allyn Welch Allyn Connex Spot Monitor, Product Code/ Part Numbers: 1) 73WT-B; 2) 74CE-B; 3) 74CT-B; 4) 74
Hazard: Undeclared natural rubber band within the packaging of certain configurations of reusable blood pressure cuffs.
April 23, 2025Medical DevicesFDA
Baxter Healthcare Corporation recalls Welch Allyn Connex Integrated Wall System, Product Code/Part Numbers: 1) 84MTVE2-4; 2) 84MTVE2-6; 3) 84MTVE2-B;
Hazard: Undeclared natural rubber band within the packaging of certain configurations of reusable blood pressure cuffs.
April 23, 2025Medical DevicesFDA
Baxter Healthcare Corporation recalls Welch Allyn CP150 Electrocardiograph:
Hazard: There were customer reports of devices which experienced battery-related fires. The investigation found that the devices in question were utilizing third-party, after-market batteries that are not approved by Baxter.
April 23, 2025Medical DevicesFDA
Baxter Healthcare Corporation recalls Welch Allyn CONNEX Accessory Power Management Stand:
Hazard: There were customer reports of devices which experienced battery-related fires. The investigation found that the devices in question were utilizing third-party, after-market batteries that are not approved by Baxter.
April 23, 2025Medical DevicesFDA
Baxter Healthcare Corporation recalls Welch Allyn Connex Vital Signs Monitor (CVSM):
Hazard: There were customer reports of devices which experienced battery-related fires. The investigation found that the devices in question were utilizing third-party, after-market batteries that are not approved by Baxter.
April 2, 2025Medical DevicesFDA
Baxter Healthcare Corporation recalls Progressa Bed Surfaces, intended to be used to treat or prevent pulmonary or other complications associated with immobil
Hazard: 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.
April 2, 2025Medical DevicesFDA
Baxter Healthcare Corporation recalls Baxter NovumIQ Syringe INFUSION SYSTEM , REF 40800BAXUS
Hazard: Baxter Healthcare Corporation is issuing an Urgent Medical Device Recall for the Novum IQ syringe pumps listed below due to an incorrectly installed gasket. A gasket failure could lead to potential fluid ingress due to cleaning, or as a result of an IV fluid spill.
April 2, 2025Medical DevicesFDA
Baxter Healthcare Corporation recalls Baxter TruSystem 7500, Product Code 4091000
Hazard: There is a software issue which causes the upper back section to not be operable/adjustable when the "emergency mode" function is enabled.