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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 30, 2024Medical DevicesFDA
Baxter Healthcare Corporation recalls Baxter Operating Table TruSystem 7000 (dV), Product code REF 1841049
Hazard: The firm received customer reports stating that the batteries and their connectors experienced electrical short-circuits and/or emitted smoke.
October 30, 2024Medical DevicesFDA
Baxter Healthcare Corporation recalls Baxter Operating Table TruSystem 7000 (MBW), Product code REF 1841048
Hazard: The firm received customer reports stating that the batteries and their connectors experienced electrical short-circuits and/or emitted smoke.
October 30, 2024Medical DevicesFDA
Baxter Healthcare Corporation recalls Baxter Operating Table TruSystem 7000, Product code REF 1841046
Hazard: The firm received customer reports stating that the batteries and their connectors experienced electrical short-circuits and/or emitted smoke.
October 30, 2024Medical DevicesFDA
Baxter Healthcare Corporation recalls Baxter Operating table TruSystem 7000 U (MB), Product codes: a) REF 1604786; b) REF 1604788; c) REF 1723633
Hazard: The firm received customer reports stating that the batteries and their connectors experienced electrical short-circuits and/or emitted smoke.
October 30, 2024Medical DevicesFDA
Baxter Healthcare Corporation recalls Welch Allyn Life2000 Ventilation System, REF MS-01-0118, within exterior carton codes: 1) BT-20-0002, 2) BT-20-0002A, 3
Hazard: The Life2000 ventilator may fail to initiate the Low Gas Pressure alarm if the pressure gas source (Life2000 compressor, oxygen cylinder or wall source) is not supplied to the ventilator before initiating therapy.
September 25, 2024Medical DevicesFDA
Baxter Healthcare Corporation recalls Baxter EXACTAMIX Inlet, Vented, Syringe Inlet, REF H938176, for use in a pharmaceutical compounding device
Hazard: Baxter Healthcare Corporation has received increased customer reports of particulate matter in the Automated Compounding Device Inlets (disposable inlet), Product Codes H938173, H938174, H938175, H938176, used with the ExactaMix and ExactaMix Pro compounders. Particulate matter has been observed within the inlet primary packaging inlet components, including within the sterile fluid path tubing, before use.
September 25, 2024Medical DevicesFDA
Baxter Healthcare Corporation recalls Baxter EXACTAMIX Inlet, Vented, Micro-Volume Inlet, REF H938175, for use in a pharmaceutical compounding device
Hazard: Baxter Healthcare Corporation has received increased customer reports of particulate matter in the Automated Compounding Device Inlets (disposable inlet), Product Codes H938173, H938174, H938175, H938176, used with the ExactaMix and ExactaMix Pro compounders. Particulate matter has been observed within the inlet primary packaging inlet components, including within the sterile fluid path tubing, before use.
September 25, 2024Medical DevicesFDA
Baxter Healthcare Corporation recalls Baxter EXACTAMIX Inlet, Vented, High Volume Inlet, REF H938174, for use in a pharmaceutical compounding device
Hazard: Baxter Healthcare Corporation has received increased customer reports of particulate matter in the Automated Compounding Device Inlets (disposable inlet), Product Codes H938173, H938174, H938175, H938176, used with the ExactaMix and ExactaMix Pro compounders. Particulate matter has been observed within the inlet primary packaging inlet components, including within the sterile fluid path tubing, before use.
September 25, 2024Medical DevicesFDA
Baxter Healthcare Corporation recalls Baxter EXACTAMIX Inlet, Non-Vented, High Volume Inlet, REF H938173, for use in a pharmaceutical compounding device
Hazard: Baxter Healthcare Corporation has received increased customer reports of particulate matter in the Automated Compounding Device Inlets (disposable inlet), Product Codes H938173, H938174, H938175, H938176, used with the ExactaMix and ExactaMix Pro compounders. Particulate matter has been observed within the inlet primary packaging inlet components, including within the sterile fluid path tubing, before use.
September 11, 2024DrugsFDA
Baxter Healthcare Corporation recalls Heparin (Heparin Sodium in 0.9% Sodium Chloride Injection), 2,000 units per 1,000 mL (2 units/mL), 1000 mL Sterile Singl
Hazard: Microbial Contamination of Sterile Products; out of limit results obtained for endotoxin testing.
August 28, 2024Medical DevicesFDA
Baxter Healthcare Corporation recalls Spectrum Wireless Battery Modules A/B/G/N, product code 36010, used with either of the following 35700BAX2 (Spectrum V8
Hazard: The Spectrum WBM may fail to auto-document infusion status information back to the hospital's Electronic Medical Record (EMR) system. This software issue only impacts customers where the Spectrum V8 or Spectrum IQ infusion system is integrated with the hospital s EMR system.
August 28, 2024Medical DevicesFDA
Baxter Healthcare Corporation recalls Baxter Spectrum Wireless Battery Modules A/B/G/N, product code 35223, used with either of the following: 35700BAX2 (Spe
Hazard: The Spectrum WBM may fail to auto-document infusion status information back to the hospital's Electronic Medical Record (EMR) system. This software issue only impacts customers where the Spectrum V8 or Spectrum IQ infusion system is integrated with the hospital s EMR system.
August 14, 2024Medical DevicesFDA
Baxter Healthcare Corporation recalls Baxter SIGMA Spectrum Infusion Pump, Product Code: 35700BAX2
Hazard: Improperly performed testing prior to release
August 14, 2024Medical DevicesFDA
Baxter Healthcare Corporation recalls Baxter PST 500 U, Precision Surgical Table, Part number (product code) 4080300
Hazard: Baxter Healthcare Corporation is issuing an Urgent Medical Device Correction for the PST 500 U Precision Surgical Table due to a potential issue with loose spring pins in the spindle drives. This can cause the tabletop to unexpectedly tilt or move at any time, even without active use of the surgical table. This could potentially result in unintentional patient movement during surgical procedures and/or preparation for surgical procedures, including transport.
July 24, 2024Medical DevicesFDA
Baxter Healthcare Corporation recalls Volara System. Blue Ventilator Adapter Module. Intermittent positive pressure breathing device component.
Hazard: Potential of the handset plug to disconnect from the nebulizer port on the blue ventilator adapter. The handset plug is required to ensure proper operation and ventilator gas flow.
July 24, 2024Medical DevicesFDA
Baxter Healthcare Corporation recalls Volara System. Single Patient Use (SPU) Circuit 5kit for Volara and Single Patient Use (SPU) Circuit kit for Volara. In
Hazard: Potential of the handset plug to disconnect from the nebulizer port on the blue ventilator adapter. The handset plug is required to ensure proper operation and ventilator gas flow.
July 17, 2024Medical DevicesFDA
Baxter Healthcare Corporation recalls Braun Thermoscan¿ PRO 6000 Ear Thermometer
Hazard: The Braun Thermoscan PRO 6000 ear thermometers may have been shipped with a compact disc (CD) containing an outdated version of the Instructions for Use (IFU).
July 17, 2024Medical DevicesFDA
Baxter Healthcare Corporation recalls Welch Allyn CP150 Electrocardiograph with Spirometry Option, Product Code: CP150A-1ENB. The Electrocardiograph is one of
Hazard: During manufacturing, the step to install an Electromagnetic Interference (EMI) Absorber was omitted. The purpose of the EMI absorber is to prevent EMI leakage that might potentially affect other devices in the vicinity or the device itself may be vulnerable to EMI resulting in device malfunction or unavailability.
July 17, 2024Medical DevicesFDA
Baxter Healthcare Corporation recalls iLED 7 surgical lights, Model Numbers: a) 4068110 (Ceiling Single Surgical Light); b) 4068120 (Mobile Surgical Ligh
Hazard: Baxter Healthcare Corporation is issuing an Urgent Medical Device Correction due to customer reports of thermal skin injuries when using the iLED 7 surgical light system products listed below. Specific VidiaPort and Trulight product codes are also impacted as they are equipped with iLED 7 light-heads
July 17, 2024Medical DevicesFDA
Baxter Healthcare Corporation recalls Trulight 5000/3000 Surgical Light, model numbers: a) 4038210 (Duo Surgical Lights}; b) 4038310 (Trio/Quad Surgical
Hazard: Baxter Healthcare Corporation is issuing an Urgent Medical Device Correction due to customer reports of thermal skin injuries when using the iLED 7 surgical light system products listed below. Specific VidiaPort and Trulight product codes are also impacted as they are equipped with iLED 7 light-heads
July 17, 2024Medical DevicesFDA
Baxter Healthcare Corporation recalls VidiaPort carrying arm, mount for auxiliary products, model numbers: a) 4028110 (Ceiling Single Surgical Light); b)
Hazard: Baxter Healthcare Corporation is issuing an Urgent Medical Device Correction due to customer reports of thermal skin injuries when using the iLED 7 surgical light system products listed below. Specific VidiaPort and Trulight product codes are also impacted as they are equipped with iLED 7 light-heads
July 17, 2024DrugsFDA
Baxter Healthcare Corporation recalls Dianeal Low Calcium (2.5 mEq/L) Peritoneal Dialysis Solution with 2.5% Dextrose, For Intraperitoneal Administration Only
Hazard: Lack of Assurance of Sterility: Potential presence of leaks originating from the Connector Assembly component.
July 3, 2024Medical DevicesFDA
Baxter Healthcare Corporation recalls Life2000 Ventilator, Product Code: MS-01-0118, which is contained in the Life2000 Ventilator System, with Product Codes
Hazard: Potential for certain Life2000 ventilator systems to either fail to charge or have intermittent charging behavior due to damage to the battery charger dongle. Damage of the battery charger dongle prevents the ventilator's internal battery from charging.
June 26, 2024Medical DevicesFDA
Baxter Healthcare Corporation recalls Centrella Max - The Centrella Smart+ Bed is intended for use in healthcare environments as a patient support system to p
Hazard: There is a potential for the top cover of the hospital bed mattress to delaminate as a result of improper cleaning and lack of adequate details on the appropriate use of cleaning agents containing bleach.
May 22, 2024Medical DevicesFDA
Baxter Healthcare Corporation recalls Spectrum IQ Infusion pump, Product Code 357009
Hazard: There is a potential for cracks on the mount of the front panel of the device.
May 15, 2024Medical DevicesFDA
Baxter Healthcare Corporation recalls Baxter Spectrum IQ Infusion Pump, Product Code 3570009
Hazard: One device was improperly performed testing prior to release from a Service Center.
May 1, 2024Medical DevicesFDA
Baxter Healthcare Corporation recalls Baxter Seprafilm Adhesion Barrier 1 Half Sheet, 5-PK, REF 664103, for use in abdominal and pelvic surgery
Hazard: Product was distributed in the United States without proper regulatory approval.
April 24, 2024Medical DevicesFDA
Baxter Healthcare Corporation recalls Surgical Tools and Cardiovascular Specialty marketing brochures, Reference numbers: US-AS18-210002 Surgical Tools Broch
Hazard: The Surgical Tools and Cardiovascular Specialty marketing brochures distributed for Flo-Rester Disposable Internal Vessel Occluder, Flo-Thru Intraluminal Shunt, and Vascular Probe Intravascular Probe contain inaccurate content that does not align with the products Instructions for Use (IFU).
April 24, 2024Medical DevicesFDA
Baxter Healthcare Corporation recalls Surgical Tools and Cardiovascular Specialty marketing brochures, Reference numbers: US-AS18-210002 Surgical Tools Broch
Hazard: The Surgical Tools and Cardiovascular Specialty marketing brochures distributed for Flo-Rester Disposable Internal Vessel Occluder, Flo-Thru Intraluminal Shunt, and Vascular Probe Intravascular Probe contain inaccurate content that does not align with the products Instructions for Use (IFU).
April 24, 2024Medical DevicesFDA
Baxter Healthcare Corporation recalls Surgical Tools and Cardiovascular Specialty marketing brochures, Reference numbers: US-AS18-210002 Surgical Tools Broch
Hazard: The Surgical Tools and Cardiovascular Specialty marketing brochures distributed for Flo-Rester Disposable Internal Vessel Occluder, Flo-Thru Intraluminal Shunt, and Vascular Probe Intravascular Probe contain inaccurate content that does not align with the products Instructions for Use (IFU).