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Baxter Healthcare Corporation

FDA Regulatory Profile

Baxter Healthcare Corporation appears in FDA public data with 434 recalls — including 75 Class I (most serious) —, 61 510(k) clearances, 105 FDA inspections, and 9 compliance actions on record. Its most recent recall (D-0850-2026, Class I) was initiated on August 17, 2026. Its most recent 510(k) clearance was granted on December 16, 2025.

Summary

Total Recalls
434 (75 Class I)
510(k) Clearances
61
Inspections
105
Compliance Actions
9

Recent Recalls

NumberClassProductDate
D-0850-2026Class IDextrose Injection, USP, 70 %, 2000 mL bags, Rx Only, Baxter Healthcare Corporation Deerfield, IL, 6August 17, 2026
D-0849-2026Class I0.9% Sodium Chloride Injection USP 500 mL, VIAFLEX Plastic Containers, with 24 units per case. BaxteAugust 17, 2026
Z-3066-2026Class IIBaxter Novum IQ Syringe Pump, Loaner, Model Number 40800BAXUSLAugust 11, 2026
Z-3065-2026Class IIBaxter Novum IQ Syringe Pump, Model Number 40800BAXUSAugust 11, 2026
D-0806-2026Class IIMYXREDLIN, Insulin Human in 0.9% Sodium Chloride Injection, 100 units/100 mL (1 unit/mL), Rx only, BAugust 6, 2026
D-0811-2026Class IIVasopressin, in 0.9% Sodium Chloride Injection, 20 units per 100 mL (0.2 units/mL), 100mL Single-DosAugust 6, 2026
D-0812-2026Class IIPantoprazole Sodium in 0.9% Sodium Chloride Injection, 80 mg/100 mL (0.8 mg/mL) Single-Dose InfusionAugust 6, 2026
D-0815-2026Class IIClindamycin Injection USP in 5% Dextrose, 900 mg per 50 mL (12 mg/mL) in GALAXY 50 mL Single Dose CoAugust 6, 2026
D-0819-2026Class IIVasopressin, in 0.9% Sodium Chloride Injection, 40 units per 100 mL (0.4 units/mL), 100mL Single-DosAugust 6, 2026
D-0807-2026Class IIDaptomycin, in 0.9% Sodium Chloride Injection, 500 mg per 50 mL (10 mg/mL), 500 mg total, in 50 mL SAugust 6, 2026
D-0805-2026Class IIVancomycin Injection, USP in 5% Dextrose, 1 g per 200mL (5 mg/mL), in GALAXY Single-Dose Container, August 6, 2026
D-0808-2026Class IIClindamycin Injection USP in 5% Dextrose, 600 mg per 50 mL (12 mg/mL) in GALAXY 50 mL Single Dose CoAugust 6, 2026
D-0817-2026Class IIClindamycin Injection USP in 5% Dextrose, 900 mg/50 mL (18 mg/mL), in GALAXY 50 mL Single Dose ContaAugust 6, 2026
D-0809-2026Class IIFamotidine Injection in Sodium Chloride Injection, 20 mg, 50 mL in GALAXY Single Dose Container, Rx August 6, 2026
D-0818-2026Class IIClindamycin Injection USP in 5% Dextrose, 900 mg/50 mL (18 mg/mL), in GALAXY 50 mL Single Dose ContaAugust 6, 2026
D-0816-2026Class IIClindamycin Phosphate in 0.9% Sodium Chloride Injection, 600 mg per 50 mL (12 mg/mL), 50 mL Single-DAugust 6, 2026
D-0821-2026Class IIDaptomycin, in 0.9% Sodium Chloride Injection, 1,000 mg per 100 mL (10 mg/mL), 1,000 mg total, in 10August 6, 2026
D-0820-2026Class IIVancomycin Injection, USP, in 0.9% Sodium Chloride, 1g per 200 mL (5 mg/mL) in GALAXY Single-Dose CoAugust 6, 2026
D-0814-2026Class IINexterone (amiodarone HCI), 360 mg/200 mL (1.8 mg/mL) in GALAXY Single-Dose Container, sterile, NonpAugust 6, 2026
D-0813-2026Class IICARDENE IV (Nicardipine Hydrochloride) in 0.83% Sodium Chloride Injection, 40 mg in 200 mL (0.2 mg/mAugust 6, 2026

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
K230665Dose IQ Safety SoftwareMarch 29, 2024
K211122Novum IQ Large Volume PumpMarch 29, 2024
K232467CleanCart A, CleanCart C, AK 98 Hemodialysis MachineSeptember 14, 2023
K230022Baxter SIGMA Spectrum Infusion Pump with Master Drug LibraryMarch 31, 2023
K230041Spectrum IQ Infusion System with Dose IQ Safety SoftwareMarch 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

FDA data resources