Baxter Healthcare Corporation
287 recalls on record · Latest: Feb 4, 2026
FDA Devices Moderate Dec 30, 2020
Baxter SIGMA Spectrum Infusion Pump with Master Drug Library (Version 6) - Product Usage: intended to be used for the controlled administration of fl…
FDA Devices Moderate Dec 30, 2020
Baxter SIGMA Spectrum Infusion Pump with Master Drug Library (Version 8) - Product Usage: intended to be used for the controlled administration of fl…
FDA Devices Moderate Dec 30, 2020
Baxter Spectrum IQ Infusion System with Dose IQ Safety Software - Product Usage: intended to be used for the controlled administration of fluids.
FDA Devices Moderate Dec 30, 2020
Baxter SIGMA Spectrum Infusion Pump with Master Drug Library (Version 6) - Product Usage: intended to be used for the controlled administration of fl…
FDA Drug Moderate Nov 18, 2020
Bupivacaine Hydrochloride in 8.25% Dextrose Injection, USP Spinal 0.75% (15 mg/2 mL) 10 x 2 mL single-dose ampules, Rx only, Manufactured for: Baxter…
FDA Devices Critical Oct 28, 2020
Baxter SIGMA Spectrum Infusion Pump with Master Drug Library (Version 8)
FDA Devices Critical Oct 28, 2020
Baxter SIGMA Spectrum Infusion Pump with Master Drug Library (Version 8)
FDA Devices Critical Oct 28, 2020
Spectrum IQ Infusion System with Dose IQ Safety Software
FDA Devices Moderate Jul 8, 2020
Flow Coupler Monitor, GEM, Global Excellence Microsurgery, Rx Only
FDA Devices Moderate Jun 10, 2020
Gambro Cartridge Low Weight-Low Volume Blood Transport System for Hemodialysis Blood Set - Product Usage: is intended for single use in a hemodialysi…
FDA Devices Moderate Jun 10, 2020
Gambro Cartridge Blood Set Prime Line - Product Usage: is intended for single use in a hemodialysis treatment using Dialysis Delivery Systems.
FDA Devices Moderate Jun 10, 2020
Gambro Cartridge Blood Transport System for Hemodialysis Blood Set - Product Usage: is intended for single use in a hemodialysis treatment using Dial…
FDA Devices Moderate May 27, 2020
Prismaflex Control Unit
FDA Devices Moderate May 6, 2020
Prismaflex System, Prismaflex Control Unit
FDA Devices Moderate May 6, 2020
Prismaflex System, Prismaflex Control Unit
FDA Devices Moderate May 6, 2020
Prismaflex System, Prismaflex Control Unit
FDA Devices Moderate May 6, 2020
Prismaflex System, Prismaflex Control Unit
FDA Devices Moderate Apr 15, 2020
GEM Microvascular Anastomotic Coupler Devices - Product Usage: s intended to be used in the anastomosis of veins and arteries normally encountered in…
FDA Devices Moderate Apr 15, 2020
GEM Microvascular Anastomotic Coupler Devices s intended to be used in the anastomosis of veins and arteries normally encountered in microsurgical pr…
FDA Devices Moderate Mar 11, 2020
Revaclear Capillary Dialyzer 300, REF Revaclear 300 Product Code 114745L
FDA Devices Moderate Jan 15, 2020
Clearlink System Continu-Flo Administration Sets, Product Codes: 2C8519, 2C8537, and 2C8541 - Product Usage:For the administration of fluids from a …
FDA Drug Moderate Nov 27, 2019
0.9% Sodium Chloride Irrigation USP 5000 mL bags, Rx Only, Baxter Healthcare Corporation Deerfield, IL 60015, NDC 0338-0047-29
FDA Devices Moderate Nov 13, 2019
Prismaflex Control Unit, software versions below 7.21
FDA Devices Moderate Nov 13, 2019
Prismaflex Control Unit, software versions below 7.21
FDA Devices Moderate Nov 13, 2019
Prismaflex Control Unit, software versions below 7.21
FDA Devices Moderate Nov 13, 2019
Prismaflex Control Unit, software versions below 7.21
FDA Devices Moderate Nov 13, 2019
Prismaflex Control Unit, software versions below 7.21
FDA Devices Moderate Nov 6, 2019
TherMax Blood Warmer Unit
FDA Devices Moderate Oct 30, 2019
EXACTAMIX Empty EVA (Ethylene Vinyl Acetate) TPN Bag with the following product code and sizes: 1. H938737, 250mL; 2. H938738, 500mL; 3.…
FDA Devices Moderate Oct 9, 2019
L5C4531 X1 Integrated APD Set with Cassette 3-Prong Sterile, nonpyrogenic fluid path. Sterilized by ethylene oxide.
FDA Devices Low Sep 4, 2019
EXACTAMED Oral Dispensers, 5mL, AMBER: PHARMACY PACK, REF H9388505, x500 PHARMACY PACK, REF H9388105, x100 COST CONTAINMENT, REF H93884205, x1500
FDA Drug Moderate Jul 31, 2019
0.9% Sodium Chloride Injection USP, 100 mL Viaflex Container, Rx Only, Baxter Healthcare Corporation, Deerfield, IL 60015, USA, NDC 0338-0049-38.
FDA Devices Moderate Jul 10, 2019
REVACLEAR 400 Dialyzer, Product Code 114746L Revaclear 300 and Revaclear 400 dialyzers are indicated for treatment of chronic and acute renal fai…
FDA Drug Moderate Jun 19, 2019
Sevoflurane, USP Inhalation Anesthetic 250 mL bottles, Rx only, Manufactured for Baxter Healthcare Corporation Deerfield, IL 60015 USA, NDC 10019-651…
FDA Devices Moderate May 8, 2019
Baxter SIGMA Spectrum Infusion Pump with Master Drug Library (Version 6), product code 35700BAX - Product Usage: The Baxter SIGMA Spectrum Infusion P…
FDA Devices Moderate Feb 27, 2019
Kaguya Automated Peritoneal Dialysis System Product Usage: It is intended for automatic control of dialysate solution exchanges in the treatment …
FDA Devices Moderate Feb 27, 2019
AMIA Automated Peritoneal Dialysis System Product Usage: It is intended for automatic control of dialysate solution exchanges in the treatment o…
FDA Drug Moderate Jan 16, 2019
Dianeal Low Calcium (2.5 mEq/L) Peritoneal Dialysis Solution with 1.5% Dextrose, 2000 mL UltraBag container bag, Rx only; Baxter Healthcare Corporati…
FDA Devices Moderate Jan 2, 2019
GEM Coupler Forceps, GEM4183C, packaged individually.
FDA Drug Low Nov 14, 2018
Metoprolol Tartrate Injection, USP, 5 mg/ 5 mL (1 mg/mL), 5 mL per sterile single use glass vial, Rx Only, Manufactured for: Claris Lifesciences, Inc…
FDA Devices Moderate Nov 7, 2018
EXACTAMIX Empty EVA Bags - 250 mL Product Usage: A plastic container used to hold large-volume sterile solutions to be administered to a patient thro…
FDA Devices Moderate Nov 7, 2018
EXACTAMIX Empty EVA Bags - 3000 mL Product Usage: A plastic container used to hold large-volume sterile solutions to be administered to a patient thr…
FDA Devices Moderate Nov 7, 2018
EXACTAMIX Empty EVA Bags - 1000 mL Product Usage: A plastic container used to hold large-volume sterile solutions to be administered to a patient thr…
FDA Devices Moderate Nov 7, 2018
EXACTAMIX Empty EVA Bags - 2000 mL Product Usage: A plastic container used to hold large-volume sterile solutions to be administered to a patient thr…
FDA Devices Moderate Nov 7, 2018
EXACTAMIX Empty EVA Bags - 500 mL - Product Usage: A plastic container used to hold large-volume sterile solutions to be administered to a patient th…
FDA Devices Moderate Oct 24, 2018
SPECTRUM IQ INFUSION SYSTEM WITH DOSE IQ SAFETY SOFTWARE, 3570009
FDA Drug Low Oct 3, 2018
Levofloxacin Injection in 5% Dextrose, 5 mg/mL, packaged in a) 50 mL (NDC 36000-046-24), b) 100 mL (NDC 36000-047-24), c) 150 mL (NDC 36000-048-24) C…
FDA Drug Moderate Sep 26, 2018
0.9% Sodium Chloride Injection USP 50 mL Viaflex container Baxter Healthcare Corporation Deerfield, IL 60015 -- NDC 0338-0049-31
FDA Drug Moderate Sep 5, 2018
0.9% Sodium Chloride Injection USP 100 mL bags, Rx only, Baxter Healthcare Corporation Deerfield, IL 60015 USA, NDC 0338-0049-18
FDA Devices Moderate Sep 5, 2018