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Baxter Healthcare Corporation Recalls

269 recalls on record. Search official CPSC, FDA, and USDA datasets for every recall issued for Baxter Healthcare Corporation.

269Total Recalls
40Critical
383.9MUnits Affected
Jan 13, 2026Most Recent
All Recalls

Every Baxter Healthcare Corporation Recall

Sorted by most recent. Click any recall for full details.

269 recalls
CriticalFDA
Baxter Healthcare Corporation
Baxter SIGMA Spectrum Infusion Pump with Master Drug Library (Version 8)
Medical Devices·310,969 affected·Jun 30, 2020
CriticalFDA
Baxter Healthcare Corporation
Baxter SIGMA Spectrum Infusion Pump with Master Drug Library (Version 8)
Medical Devices·152,539 affected·Jun 30, 2020
CriticalFDA
Baxter Healthcare Corporation
Spectrum IQ Infusion System with Dose IQ Safety Software
Medical Devices·146,224 affected·Jun 30, 2020
High RiskFDA
Baxter Healthcare Corporation
Flow Coupler Monitor, GEM, Global Excellence Microsurgery, Rx Only
Medical Devices·60 affected·Jun 2, 2020
High RiskFDA
Baxter Healthcare Corporation
Gambro Cartridge Low Weight-Low Volume Blood Transport System for Hemodialysis Blood Set - Product Usage: is intended for single use in a...
Medical Devices·4,065 affected·Apr 17, 2020
High RiskFDA
Baxter Healthcare Corporation
Gambro Cartridge Blood Set Prime Line - Product Usage: is intended for single use in a hemodialysis treatment using Dialysis Delivery Sys...
Medical Devices·2,361,885 affected·Apr 17, 2020
High RiskFDA
Baxter Healthcare Corporation
Gambro Cartridge Blood Transport System for Hemodialysis Blood Set - Product Usage: is intended for single use in a hemodialysis treatmen...
Medical Devices·53,895 affected·Apr 17, 2020
High RiskFDA
Baxter Healthcare Corporation
Prismaflex Control Unit
Medical Devices·5 affected·Apr 7, 2020
High RiskFDA
Baxter Healthcare Corporation
GEM Microvascular Anastomotic Coupler Devices - Product Usage: s intended to be used in the anastomosis of veins and arteries normally en...
Surgical Devices·209 affected·Mar 5, 2020
High RiskFDA
Baxter Healthcare Corporation
GEM Microvascular Anastomotic Coupler Devices s intended to be used in the anastomosis of veins and arteries normally encountered in micr...
Surgical Devices·0 affected·Mar 5, 2020
High RiskFDA
Baxter Healthcare Corporation
Prismaflex System, Prismaflex Control Unit
Medical Devices·2,471 affected·Feb 6, 2020
High RiskFDA
Baxter Healthcare Corporation
Prismaflex System, Prismaflex Control Unit
Medical Devices·555 affected·Feb 6, 2020
High RiskFDA
Baxter Healthcare Corporation
Clearlink System Continu-Flo Administration Sets, Product Codes: 2C8519, 2C8537, and 2C8541 - Product Usage:For the administration of fl...
Medical Devices·271,014,984 affected·Dec 12, 2019
High RiskFDA
Baxter Healthcare Corporation
0.9% Sodium Chloride Irrigation USP 5000 mL bags, Rx Only, Baxter Healthcare Corporation Deerfield, IL 60015, NDC 0338-0047-29
Drugs·22,336 affected·Nov 19, 2019
High RiskFDA
Baxter Healthcare Corporation
Revaclear Capillary Dialyzer 300, REF Revaclear 300 Product Code 114745L
Medical Devices·101,976 affected·Nov 15, 2019
High RiskFDA
Baxter Healthcare Corporation
Prismaflex Control Unit, software versions below 7.21
Medical Devices·2,760 affected·Oct 4, 2019
High RiskFDA
Baxter Healthcare Corporation
Prismaflex Control Unit, software versions below 7.21
Medical Devices·986 affected·Oct 4, 2019
High RiskFDA
Baxter Healthcare Corporation
Prismaflex Control Unit, software versions below 7.21
Medical Devices·1,014 affected·Oct 4, 2019
High RiskFDA
Baxter Healthcare Corporation
Prismaflex Control Unit, software versions below 7.21
Medical Devices·336 affected·Oct 4, 2019
High RiskFDA
Baxter Healthcare Corporation
Prismaflex Control Unit, software versions below 7.21
Medical Devices·988 affected·Oct 4, 2019
High RiskFDA
Baxter Healthcare Corporation
TherMax Blood Warmer Unit
Medical Devices·504 affected·Sep 19, 2019
High RiskFDA
Baxter Healthcare Corporation
EXACTAMIX Empty EVA (Ethylene Vinyl Acetate) TPN Bag with the following product code and sizes: 1. H938737, 250mL; 2. H938738, 50...
Medical Devices·11,389,800 affected·Sep 18, 2019
High RiskFDA
Baxter Healthcare Corporation
0.9% Sodium Chloride Injection USP, 100 mL Viaflex Container, Rx Only, Baxter Healthcare Corporation, Deerfield, IL 60015, USA, NDC 0338-...
Injectable Drugs·139,680 affected·Jul 18, 2019
High RiskFDA
Baxter Healthcare Corporation
EXACTAMED Oral Dispensers, 5mL, AMBER: PHARMACY PACK, REF H9388505, x500 PHARMACY PACK, REF H9388105, x100 COST CONTAINMENT, REF H938...
Medical Devices·2,192,000 affected·Jun 27, 2019
High RiskFDA
Baxter Healthcare Corporation
Sevoflurane, USP Inhalation Anesthetic 250 mL bottles, Rx only, Manufactured for Baxter Healthcare Corporation Deerfield, IL 60015 USA, N...
Drugs·5,940 affected·Jun 13, 2019
High RiskFDA
Baxter Healthcare Corporation
REVACLEAR 400 Dialyzer, Product Code 114746L Revaclear 300 and Revaclear 400 dialyzers are indicated for treatment of chronic and acu...
Medical Devices·65,403 affected·May 31, 2019
High RiskFDA
Baxter Healthcare Corporation
Dianeal Low Calcium (2.5 mEq/L) Peritoneal Dialysis Solution with 1.5% Dextrose, 2000 mL UltraBag container bag, Rx only; Baxter Healthca...
Drugs·29,370 affected·Jan 2, 2019
High RiskFDA
Baxter Healthcare Corporation
Kaguya Automated Peritoneal Dialysis System Product Usage: It is intended for automatic control of dialysate solution exchanges in th...
Medical Devices·1,085 affected·Dec 11, 2018
High RiskFDA
Baxter Healthcare Corporation
AMIA Automated Peritoneal Dialysis System Product Usage: It is intended for automatic control of dialysate solution exchanges in the...
Medical Devices·7,688 affected·Dec 11, 2018
Medium RiskFDA
Baxter Healthcare Corporation
Metoprolol Tartrate Injection, USP, 5 mg/ 5 mL (1 mg/mL), 5 mL per sterile single use glass vial, Rx Only, Manufactured for: Claris Lifes...
Injectable Drugs·402,165 affected·Oct 15, 2018
High RiskFDA
Baxter Healthcare Corporation
L5C4531 X1 Integrated APD Set with Cassette 3-Prong Sterile, nonpyrogenic fluid path. Sterilized by ethylene oxide.
Medical Devices·8,640 affected·Oct 10, 2018
Medium RiskFDA
Baxter Healthcare Corporation
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 360...
Injectable Drugs·523,896 affected·Sep 25, 2018
High RiskFDA
Baxter Healthcare Corporation
SPECTRUM IQ INFUSION SYSTEM WITH DOSE IQ SAFETY SOFTWARE, 3570009
Medical Devices·354 affected·Sep 18, 2018
High RiskFDA
Baxter Healthcare Corporation
EXACTAMIX Empty EVA Bags - 250 mL Product Usage: A plastic container used to hold large-volume sterile solutions to be administered to a ...
Medical Devices·158,163 affected·Sep 12, 2018
High RiskFDA
Baxter Healthcare Corporation
EXACTAMIX Empty EVA Bags - 3000 mL Product Usage: A plastic container used to hold large-volume sterile solutions to be administered to a...
Medical Devices·281,350 affected·Sep 12, 2018
High RiskFDA
Baxter Healthcare Corporation
EXACTAMIX Empty EVA Bags - 1000 mL Product Usage: A plastic container used to hold large-volume sterile solutions to be administered to a...
Medical Devices·136,800 affected·Sep 12, 2018
High RiskFDA
Baxter Healthcare Corporation
EXACTAMIX Empty EVA Bags - 2000 mL Product Usage: A plastic container used to hold large-volume sterile solutions to be administered to a...
Medical Devices·456,071 affected·Sep 12, 2018
High RiskFDA
Baxter Healthcare Corporation
EXACTAMIX Empty EVA Bags - 500 mL - Product Usage: A plastic container used to hold large-volume sterile solutions to be administered to ...
Medical Devices·110,134 affected·Sep 12, 2018
High RiskFDA
Baxter Healthcare Corporation
0.9% Sodium Chloride Injection USP 50 mL Viaflex container Baxter Healthcare Corporation Deerfield, IL 60015 -- NDC 0338-0049-31
Injectable Drugs·5,184 affected·Sep 6, 2018
High RiskFDA
Baxter Healthcare Corporation
0.9% Sodium Chloride Injection USP 100 mL bags, Rx only, Baxter Healthcare Corporation Deerfield, IL 60015 USA, NDC 0338-0049-18
Injectable Drugs·33,600 affected·Aug 21, 2018
Medium RiskFDA
Baxter Healthcare Corporation
Levofloxacin Injection in 5% Dextrose, 250 mg (5 mg/mL), 250 mg in 50 mL 5% Dextrose, 50 mL Single Use Container bag, Rx only, Manufactur...
Injectable Drugs·191,256 affected·Aug 1, 2018
Medium RiskFDA
Baxter Healthcare Corporation
Levofloxacin Injection in 5% Dextrose, 750 mg (5 mg/mL), 750 mg in 150 mL 5% Dextrose, 150 mL Single Use Container bag, Rx only, Manufact...
Injectable Drugs·711,216 affected·Aug 1, 2018
Medium RiskFDA
Baxter Healthcare Corporation
Levofloxacin Injection in 5% Dextrose, 500 mg (5 mg/mL), 500 mg in 100 mL 5% Dextrose, 100 mL Single Use Container bag, Rx only, Manufact...
Injectable Drugs·106,320 affected·Aug 1, 2018
High RiskFDA
Baxter Healthcare Corporation
Baxter SIGMA Spectrum Infusion Pump with Master Drug Library (Version 6), product code 35700BAX - Product Usage: The Baxter SIGMA Spectru...
Medical Devices·158 affected·Jun 21, 2018
High RiskFDA
Baxter Healthcare Corporation
FLOSEAL Special Applicator Tips in cartons labeled in part, "Floseal SPECIAL APPLICATOR TIPS***6 x Malleable Tip Trimmable Tip***Baxter**...
Medical Devices·46,908 affected·May 30, 2018
High RiskFDA
Baxter Healthcare Corporation
Baxter SIGMA Spectrum Infusion Pump with Master Drug Library (Version 8), infusion pump, 35700BAX2 Product Usage: The Baxter SIGMA Sp...
Medical Devices·122,889 affected·May 8, 2018
High RiskFDA
Baxter Healthcare Corporation
Baxter SIGMA Spectrum Infusion Pump with Master Drug Library (Version 6), infusion pump, 35700BAX and 35700ABB Product Usage: The Bax...
Medical Devices·333,961 affected·May 8, 2018
High RiskFDA
Baxter Healthcare Corporation
Baxter EXACTAMIX Inlet, Vented, High-Volume Inlet, REF H938174 Usage: Exacta-Mix 2400 Compounding System Administration set is a disp...
Medical Devices·59,475 affected·Apr 25, 2018