Baxter Healthcare Corporation

FDA Regulatory Profile

Summary

Total Recalls
403 (66 Class I)
510(k) Clearances
61
Inspections
103
Compliance Actions
8

Recent Recalls

NumberClassProductDate
Z-1368-2026Class IIBrand Name: Spectrum IQ Product Name: Infusion Pump Model/Catalog Number: 3570009 Software VersioJanuary 13, 2026
D-0296-2026Class IISterile Water for Irrigation, 250 mL, Single-Dose Plastic Bottle, Rx Only, Baxter Healthcare CorporaDecember 22, 2025
Z-1121-2026Class IISIGMA Spectrum Infusion Pump, Model/Catalog Number: 35700BAX2November 28, 2025
Z-0847-2026Class IIWelch Allyn INF BAG, Thigh 1-Tube, Model/Catalog Number: REF 5089-18; Product replacement bladder fOctober 28, 2025
Z-0233-2026Class IIOral Probe (Product code 02893-000), accessory used with Welch Allyn SureTemp Plus 690 (Product codeSeptember 17, 2025
Z-0192-2026Class IICLEARLINK SYSTEM CONTINU-FLO Solution Set, Non-Vented, two CLEARLINK Luer Activated Valves, BackchecAugust 29, 2025
Z-0202-2026Class IICLEARLINK SYSTEM CONTINU-FLO Solution Set, Non-Vented, three CLEARLINK Luer Activated Valves, BackchAugust 29, 2025
Z-0198-2026Class IICLEARLINK SYSTEM EXTENSION SET, Straight-Type Extension Set, Standard Bore, CLEARLINK Luer ActivatedAugust 29, 2025
Z-0200-2026Class IICLEARLINK System Non_DEHP Extenstion Set, Straight-Type Extension Set, Standard Bore, 1.2 Micron FiAugust 29, 2025
Z-0196-2026Class IICLEARLINK SYSTEM CONTINU-FLO Solution Set, Non-Vented, 0.2 Micron Filter, three CLEARLINK Luer ActivAugust 29, 2025
Z-0195-2026Class IICLEARLINK SYSTEM CONTINU-FLO Solution Set, Non-Vented, 0.2 Micron Filter, two CLEARLINK Luer ActivatAugust 29, 2025
Z-0199-2026Class IICLEARLINK SYSTEM EXTENSION SET, Straight-Type Extension Set, Standard Bore, CLEARLINK Luer ActivateAugust 29, 2025
Z-0204-2026Class IICLEARLINK SYSTEM NON-DEHP CONTINU-FLO SOLN SET, 96" (2,4 m), Product Code: 2H8519August 29, 2025
Z-0197-2026Class IICLEARLINK SYSTEM EXTENSION SET, Straight-Type Extension Set, Standard Bore, CLEARLINK Luer ActivateAugust 29, 2025
Z-0201-2026Class IICLEARLINK SYSTEM CONTINU-FLO Solution Set, Non-Vented, two CLEARLINK Luer Activated Valves. 10 dropsAugust 29, 2025
Z-0193-2026Class IICLEARLINK SYSTEM CONTINU-FLO Solution Set, Non-Vented, three CLEARLINK Luer Activated Valves, BackchAugust 29, 2025
Z-0203-2026Class IICLEARLINK System Paclitaxel Set, Non-Vented with Polyethylene Lined Tubing and CLEARLINK Luer ActivaAugust 29, 2025
Z-0191-2026Class IICLEARLINK SYSTEM Solution Set, Non-Vented, two CLEARLINK Luer Activated Valves, 10 drops/mL, 100-incAugust 29, 2025
Z-0190-2026Class IICLEARLINK System Solution Set, DUO-VENT, CLEARLINK Luer Activated Valve, 10 drops/mL, 92-inch (2.3 mAugust 29, 2025
Z-0194-2026Class IICLEARLINK SYSTEM CONTINU-FLO Solution Set, Non-Vented, three CLEARLINK Luer Activated Valves, BackchAugust 29, 2025

Recent 510(k) Clearances

K-NumberDeviceDate
K251745Welch Allyn FlexiPort Blood Pressure Cuffs (FlexiPort Blood Pressure Cuffs)December 16, 2025
K251640SIGMA Spectrum Infusion Pump with Master Drug LibraryJuly 28, 2025
K251636Spectrum IQ Infusion System with Dose IQ Safety Software (3570009)July 28, 2025
K243529Solution Administration SetsMarch 14, 2025
K242339Intravascular Extension Sets and AccessoriesFebruary 28, 2025
K242390Novum IQ Syringe Pump (40800BAXUS)September 5, 2024
K241564Actifuse ABX; Actifuse MIS; Actifuse Shape; ALTAPORE; ALTAPORE SHAPE; ALTAPORE MISAugust 2, 2024
K211122Novum IQ Large Volume PumpMarch 29, 2024
K230665Dose IQ Safety SoftwareMarch 29, 2024
K232467CleanCart A, CleanCart C, AK 98 Hemodialysis MachineSeptember 14, 2023
K230041Spectrum IQ Infusion System with Dose IQ Safety SoftwareMarch 31, 2023
K230022Baxter SIGMA Spectrum Infusion Pump with Master Drug LibraryMarch 31, 2023
K223175lntravascular Administration Sets with Stopcock and ManifoldMarch 10, 2023
K220558Blood Administration SetsNovember 17, 2022
K212262PCA Syringe SetsOctober 3, 2022
K222048Spectrum IQ Infusion System with Dose IQ Safety SoftwareSeptember 6, 2022
K211125Novum IQ Syringe PumpAugust 30, 2022
K211124Dose IQ Safety SoftwareAugust 30, 2022
K220417Spectrum IQ Infusion System with Dose IQ Safety SoftwareApril 29, 2022
K212216Prismaflex ST60 Set, Prismaflex ST100 Set, Prismaflex ST150 setApril 1, 2022