Baxter Healthcare Corporation
287 recalls on record · Latest: Feb 4, 2026
FDA Devices Moderate Apr 10, 2024
Hill-Rom PRO+ 36" MRS Surface, REF P7924A03, The pro+ mattress is intended for patient support and for the prevention and/or treatment of pressure in…
FDA Devices Moderate Apr 3, 2024
Baxter Supple Peri-Guard Repair Patch (legacy product codes): a) PC0404SNBIO, b) PC0608NSBIO, c) PC0814SNBIO, d) PC1016SNBIO
FDA Devices Moderate Apr 3, 2024
Baxter Peri-Guard Repair Patch (new product codes): a) PG0404, b) PG0608, c) PG0814, d) PG1016, e) PG1225
FDA Devices Moderate Apr 3, 2024
Baxter Peri-Guard Repair Patch (legacy product codes): a) PC0404NBIO, b) PC0608NBIO, c) PC0814NBIO, d) PC1016NBIO
FDA Devices Moderate Apr 3, 2024
Baxter Supple Peri-Guard Repair Patch (new product codes): a) SPG0404, b) SPG0406, c) SPG0608, d) SPG0814, e) SPG1016
FDA Devices Moderate Mar 27, 2024
HDS Traction Boot II, REF AR-6529-23, The Traction Boot is designed to position, support and/or distract the patient's foot for hip surgery
FDA Devices Moderate Mar 20, 2024
CLEARLINK Non-DEHP Solution Set Luer Lock Adapter, Product Code 2R8401
FDA Drug Moderate Feb 28, 2024
Norepinephrine Bitartrate in 5% Dextrose Injection, 8 mg/ 250 mL (32 mcg/mL), For Intravenous Infusion Only, 250 mL vial, Rx Only, Baxter Healthcare …
FDA Devices Moderate Jan 17, 2024
Baxter Flo-Thru Intraluminal Shunt, Product Codes: a) Product Code FT12100, 1.00 GLOBAL; b) Product Code FT12125, 1.25 GLOBAL; c) Product Code …
FDA Devices Moderate Jan 17, 2024
Baxter Floseal Hemostatic Matrix Fast Prep, Product Codes: a) ADS201844, 5 mL b) ADS201845, 10mL
FDA Devices Moderate Jan 17, 2024
Vascu-Guard Peripheral Vascular Patch (US), Product Codes: a) VG0108: 0.8 X 8 CM US, TS; b) VG0110: 1 X 10 CM US, TS; c) VG0106: 1 X 6 CM US,…
FDA Devices Moderate Jan 17, 2024
XScribe CP Cardiac Stress Testing System, version 6, with below product names and codes: a) X-SCRIBE CPI KIT WIRELESS USB 608 MHz, 41000-030-50; b) …
FDA Devices Moderate Jan 17, 2024
Baxter FloSeal Hemostatic Matrix NL, 5 mL, Product Codes: ADS201883
FDA Devices Moderate Jan 17, 2024
Baxter Flo-Rester, Disposable internal vessel occluder, distributed in the following sizes: a) Product Code 50100: 12MM, 1.00 MM GLOBAL; b) Produ…
FDA Devices Moderate Jan 17, 2024
PERI-GUARD SUPPLE, Product Codes: a) SPG1016: 10X16 CM US, TS; b) SPG0404: 4 X 4 CM US, TS; c) SPG0608: 6 X 8 CM US, TS; d) SPG0814: 8 X…
FDA Devices Moderate Jan 17, 2024
Baxter Coseal Premix, Surgical Sealant, Product Codes: a) 934070; b) 934071; c) 934072
FDA Devices Moderate Jan 17, 2024
Vascu-Guard Peripheral Vascular Patch (GLOBAL), Product Codes: a) VG0108N: 0.8X8 CM GLOBAL, b) VG0110N: 1X10 CM GLOBAL, c) VG0106N: 1X6 CM…
FDA Devices Moderate Dec 20, 2023
Baxter Amia Automated Peritoneal Dialysis (APD) Cycler Set, REF 5C5479
FDA Drug Moderate Dec 13, 2023
Ondansetron Injection, USP, 4 mg/2 mL (2 mg/mL), 2 mL per vial, Rx only, Manufactured for: Baxter Healthcare Corporation, Deerfield, IL 60015 USA. M…
FDA Devices Moderate Nov 8, 2023
HILLROM PROGRESSA+ BED, Product Codes: P7501A000016, P7501A000019, P7501A000031, P7501A000032, P7501A000033, P7501A000052, P7501A000053, P7501A00005…
FDA Drug Moderate Oct 25, 2023
Doxil (doxorubicin hydrochloride liposome injection) 50 mg in 25 mL (2 mg/mL), Single-Dose Vial, Rx only, Manufactured for: Baxter Healthcare Corpora…
FDA Devices Moderate Oct 4, 2023
Baxter Epiphany Cardio Server E3 ECG Management System Servers with software versions: a) v6.1.x, b) v6.2.x, c) v7.0.x.
FDA Devices Moderate Sep 20, 2023
Welch Allyn Connex Spot Monitor
FDA Drug Moderate Sep 6, 2023
Dianeal PD-2 Peritonial Dialysis Solution with 1.5% Dextrose, 5000 mL AMBU-FLEX ll Container with yellow pull ring, Rx Only, Baxter Healthcare Corpor…
FDA Drug Moderate Sep 6, 2023
DIANEAL Low Calcium (2.5 mEq/L) Peritoneal Dialysis Solution 1.5% Dextrose, packaged in a) 2000 mL AMBU-FLEX II Container bag, Product Code L5B4825, …
FDA Drug Low Aug 30, 2023
Bendamustine HCl Injection, 100mg/4mL (25mg/mL), One 4 mL Multiple-Dose Vial, Rx only, Manufactured for Baxter Healthcare Corporation, Deerfield, IL …
FDA Devices Moderate Jul 26, 2023
GEM FLOW COUPLER Monitor, PN 5156-00000-011
FDA Devices Critical Jul 19, 2023
The Spectrum IQ Infusion System with Dose IQ Safety Software, Product Code 3570009
FDA Devices Moderate Jul 19, 2023
Allen Advance Chest Support with Pad
FDA Devices Moderate Jul 5, 2023
NaviCare Patient Safety V3.9.200 to 3.9.600, used with the Centrella Bed
FDA Devices Moderate Jul 5, 2023
Voalte Patient Safety, Part Number 4.0, V4.0.000 to 4.0.401, used with the Centrella Bed
FDA Devices Moderate May 10, 2023
Hill-Rom pro+ mattress, product codes (REF): a) 20877002S, b) 20877003S, c) 20877004S, d) 20877007S, e) 20877008S, f) 21649301S, g) 21649401S, h) 21…
FDA Drug Moderate May 3, 2023
Dianeal PD-2 Peritonial Dialysis Solution with 1.5% Dextrose, 3000 mL per Ambu-Flex II Container bag, Rx Only, Baxter Healthcare Corporation, Deerfie…
FDA Drug Moderate May 3, 2023
Dianeal Low Calcium (2.5 mEq/L) Peritonial Dialysis Solution with 1.5% Dextrose, packaged in a) 5000 mL per Ambu-Flex II Container bag, Product Code …
FDA Devices Moderate Apr 5, 2023
Automated Peritoneal Dialysis System. Used for automatic control of dialysis solution exchanges.
FDA Devices Moderate Mar 15, 2023
Baxter MiniCap Disconnect Cap with Povidone-Iodine Solution, 5C4466P; Accessory to disposable administration set for peritoneal dialysis
FDA Devices Critical Mar 8, 2023
Life2000 Ventilator PKG, Hospital, a) REF BT200011, b) REF BT-20-0011, ventilatory support for the care of individuals
FDA Devices Moderate Dec 28, 2022
Revaclear 300 dialyzers. Indicated for treatment of chronic and acute renal failure by hemodialysis.
FDA Devices Moderate Dec 28, 2022
Revaclear 400 dialyzers. Indicated for treatment of chronic and acute renal failure by hemodialysis.
FDA Devices Moderate Nov 23, 2022
Hill-Rom Progressa Bed System
FDA Devices Critical Nov 9, 2022
Hillrom Hospital Bed Accessory, Watch Care Incontinence Management System for Progressa Bed, Product Code/Part Number P00697903.
FDA Devices Moderate Nov 9, 2022
Simple Clamp, US/EURO Rails, UPPER EXTREMITY DISTRACTION CMPT, REF F-40018, #800101. To position, support and/or distract the patients hand, wrist, …
FDA Devices Moderate Nov 9, 2022
Allen Standard Starburst, Mayfield/Doro, STANDARD SPINE POSITIONERS CMPT, REF A-70710, #800103. Component to position and support the patients hea…
FDA Devices Critical Nov 9, 2022
Hillrom Hospital Bed Accessory, Watch Care Incontinence Management System for Centrella Bed, Product Code/Part Number P00697905
FDA Devices Moderate Oct 19, 2022
Prismaflex HF20 Set (product code 109841). For use in providing continuous fluid management and renal replacement therapies.
FDA Devices Moderate Oct 19, 2022
Prismaflex ST Set: ST60 (product code 107643), ST100 (product code 107636), ST150 (product code 107640). For use in providing continuous fluid mana…
FDA Devices Moderate Oct 19, 2022
Prismaflex M Set: M60 (product code 106696), M100 (product code 106697). For use in providing continuous fluid management and renal replacement the…
FDA Devices Low Oct 5, 2022
Starling Monitor, Product code CMMST5 and Starling Monitor SV, Product code CMM-ST5 (same products); and accessories/spare parts Starling Battery Pa…
FDA Devices Critical Sep 21, 2022
Baxter CLEARLINK System, Non-DEHP Solution Set with DUO-VENT Spike, Product Code 2R8403. An in-line injection site.
FDA Devices Moderate Aug 31, 2022