The Recall Desk

Manufacturer

Baxter Healthcare Corporation

432 recalls in our database name Baxter Healthcare Corporation as the manufacturing or recalling firm.

What the numbers show

Total
432
Critical
9
Severe
88
Most recent
2026-09-09

Of the 432 recalls from Baxter Healthcare Corporation we have scored against our rubric, 9 (2%) are Critical — deaths or serious injuries reported, or the agency’s own highest classification — and 88 (20%) are Severe.

Which agencies issued them

About this listing

The manufacturer string comes from the agency’s own source notice — for FDA recalls, the “recalling firm” field; for NHTSA recalls, the vehicle manufacturer; for CPSC recalls, the firm-of-record on the joint press release. A single corporate family can appear under multiple manufacturer strings as agency notices aren’t standardized on a canonical name. If you don’t see recalls you expect, try a parent-company search or a broader full-text search.

Severity scores below are computed from the agency’s classification and the recall text, never from manufacturer behaviour or history. Many manufacturers issue routine corrective actions (software updates, labelling corrections) that are correctly scored low — having recalls on this list isn’t inherently a quality signal.

401–425 of 432

  • ModerateFDA (Devices)·Z-1909-2018·2018-05-30

    Baxter EXACTAMIX Inlets Recalled for Incorrect Over-Labeling

    Baxter Healthcare is recalling specific lots of EXACTAMIX Inlets due to incorrect over-labeling that may display extended expiration dates.

    Product
    Baxter EXACTAMIX Inlet, Vented, High-Volume Inlet, REF H938174 Usage: Exacta-Mix 2400 Compounding System Administration set is a disposable component of a compounding device used in the pharmacy to compound multiple source ingredients into one final solution.
    Category
    Medical Device
    Distribution
    0 states
  • ModerateFDA (Devices)·Z-1910-2018·2018-05-30

    Baxter EXACTAMIX Inlets Recalled for Incorrect Over-Labeling

    Baxter Healthcare is recalling specific lots of EXACTAMIX Inlets due to incorrect over-labeling that may display blank or extended expiration dates.

    Product
    Baxter EXACTAMIX Inlet, Vented, Micro-Volume Inlet, REF H938175 Usage: Exacta-Mix 2400 Compounding System Administration set is a disposable component of a compounding device used in the pharmacy to compound multiple source ingredients into one final solution.
    Category
    Medical Device
    Distribution
    0 states
  • ModerateFDA (Devices)·Z-1923-2018·2018-05-30

    Baxter Prismaflex 5.10 US Control Units Recalled for Firmware Update

    Baxter Healthcare is recalling 1,256 Prismaflex 5.10 US control units to install new firmware that prevents a pump module electronics failure.

    Product
    Prismaflex 5.10 US, Product Code 113081 Intended Use: The Prismaflex Control Unit is intended for: " Continuous Renal Replacement Therapy (CRRT) for patients weighing 20 kilograms or more with acute renal failure and/or fluid overload. " Therapeutic Plasma Exchange (TPE) ther
    Category
    Medical Device
    Distribution
    1 state
  • SevereFDA (Devices)·Z-1666-2018·2018-05-16

    Baxter Infusion Pump Recalled for Improper Testing Documentation

    Baxter Healthcare Corporation is recalling 444 Sigma Spectrum Infusion Pumps because service technicians omitted required release tests, which could lead to serious adverse health consequences.

    Product
    Baxter Sigma Spectrum Infusion Pump with Master Drug Library (Version 6) 35700BAXRP Product Usage: The Baxter Sigma Spectrum Infusion Pump with master Drug Library is intended to be used for the controlled administration of fluids. These fluids may includes pharmaceutical dru
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1667-2018·2018-05-16

    Baxter Sigma Spectrum Infusion Pump Recalled for Incomplete Testing Documentation

    Baxter Healthcare is recalling 444 Sigma Spectrum Infusion Pumps because final release testing was improperly documented, omitting critical safety checks.

    Product
    Baxter Sigma Spectrum Infusion Pump with Master Drug Library (Version 6) 35700BAXRE Product Usage: The Baxter Sigma Spectrum Infusion Pump with master Drug Library is intended to be used for the controlled administration of fluids. These fluids may includes pharmaceutical dru
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1663-2018·2018-05-16

    Baxter Sigma Spectrum Infusion Pump Recalled for Documentation Errors

    Baxter Healthcare is recalling 444 Sigma Spectrum Infusion Pumps because technicians omitted required safety tests, potentially compromising air and occlusion detection.

    Product
    Baxter Sigma Spectrum Infusion Pump with master Drug Library (Version 6) 35700BAX Product Usage: The Baxter Sigma Spectrum Infusion Pump with master Drug Library is intended to be used for the controlled administration of fluids. These fluids may includes pharmaceutical drugs
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1665-2018·2018-05-16

    Baxter Sigma Spectrum Infusion Pump Recalled for Documentation Errors

    Baxter Healthcare is recalling 444 Sigma Spectrum Infusion Pumps because technicians incorrectly documented that all final release tests were completed, when several were actually omitted.

    Product
    Baxter Sigma Spectrum Infusion Pump with Master Drug Library (Version 6) 35700BAXR Product Usage: The Baxter Sigma Spectrum Infusion Pump with master Drug Library is intended to be used for the controlled administration of fluids. These fluids may includes pharmaceutical drug
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1664-2018·2018-05-16

    Baxter Sigma Spectrum Infusion Pump Recall Due to Testing Documentation Errors

    Baxter is recalling 444 Sigma Spectrum Infusion Pumps because technicians omitted specific safety tests. The missing tests for air and occlusion detection could lead to serious health consequences.

    Product
    Baxter Sigma Spectrum Infusion Pump with master Drug Library (Version 6) 35700BAXL Product Usage: The Baxter Sigma Spectrum Infusion Pump with master Drug Library is intended to be used for the controlled administration of fluids. These fluids may includes pharmaceutical drug
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1280-2018·2018-04-11

    Baxter Recalls Prismaflex Control Units Due to Software and Usage Issues

    Baxter Healthcare is recalling 3,440 Prismaflex Control Units worldwide due to reports of operators failing to follow safe unloading instructions and software errors in specific versions.

    Product
    Prismaflex Control Unit. Dialyzer, high permeability with or without sealed dialysate system. Continuous Renal Replacement Therapy (CRRT) for patients weighing 20 kilograms or more with acute renal failure and/or fluid overload. *Therapeutic Plasma Exchange (TPE) therapy for
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0971-2018·2018-03-21

    Baxter SIGMA Spectrum Infusion Pump Recall for Pumping Mechanism Wear

    Baxter is recalling SIGMA Spectrum Infusion Pumps because excessive wear in the pumping mechanism may cause over- or under-infusion of fluids.

    Product
    Baxter SIGMA Spectrum Infusion Pump with Master Drug Library (Version 6) (GTIN 00085412091570); Model Numbers: 35700BAX and 35700ABB. Intended to be used for the controlled administration of fluids.
    Category
    Medical Device
    Distribution
    2 states
  • ModerateFDA (Devices)·Z-0806-2018·2018-03-07

    Baxter Recalls Mislabeled 5 mL Oral Dispensers Due to Packaging Errors

    Baxter Healthcare is recalling 2,800 units of 5 mL oral dispensers because the individual pouches are mislabeled with the wrong product code and volume.

    Product
    Sterile EXACTAMED Oral Dispenser, Clear, Individually Packaged, 5 mL, Product Code H93876105
    Category
    Medical Device
    Distribution
    8 states
  • SevereFDA (Drugs)·D-0573-2018·2018-02-07

    Baxter Recalls Nexterone Injection Due to Polyethylene Particulate Matter

    Baxter Healthcare is recalling Nexterone (amiodarone HCl) Premixed Injection because polyethylene particulate matter was identified in the product packaging.

    Product
    NEXTERONE — NEXTERONE (AMIODARONE HYDROCHLORIDE)
    Category
    Drug
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0485-2018·2018-02-07

    Baxter Recalls 500mL IntraVia Containers Due to Potential Sterility Leak

    Baxter Healthcare is recalling 29,088 units of 500mL IntraVia containers in the US and Canada because a leak may allow microbial contamination of the sterile fluid path.

    Product
    Empty IntraVia Container with Non-DEHP Fluid Path, 500mL Containers are intended for use in the preparation and administration of drug admixtures.
    Category
    Medical Device
    Distribution
    0 states
  • HighFDA (Devices)·Z-0411-2018·2018-01-31

    Baxter Recalls MARS Treatment Kits Due to Albumin Circuit Leakage

    Baxter Healthcare is recalling 186 MARS Treatment Kits because of a defect in the albumin circuit that causes leakage. The issue stems from an inadequate adhesive connection in the tubing.

    Product
    MARS Treatment Kit, Use only with MARS(R) Monitor 1TC, GAMBRO, Product Code 800541
    Category
    Medical Device
    Distribution
    0 states
  • HighFDA (Devices)·Z-3041-2017·2017-08-23

    Baxter HomeChoice Pro Automated Peritoneal Dialysis System Recall

    Baxter is recalling HomeChoice Pro Automated PD systems because damaged cassettes may allow air delivery to patients.

    Product
    HomeChoice Pro Automated PD system Model numbers: 5C8310, 5C8310R Product Usage: The HomeChoice Automated Personal Cycler is intended for automatic control of dialysate solution exchanges in the treatment of pediatric and adult renal failure patients undergoing peritoneal di
    Category
    Medical Device
    Distribution
    0 states
  • HighFDA (Devices)·Z-3040-2017·2017-08-23

    Baxter HomeChoice Automated PD System Recalled for Air Delivery Risk

    Baxter is recalling HomeChoice Automated PD systems because damaged cassettes may allow the device to deliver air to patients.

    Product
    HomeChoice Automated PD system Model numbers: 5C4471, 5C4471R Product Usage: The HomeChoice Automated Personal Cycler is intended for automatic control of dialysate solution exchanges in the treatment of pediatric and adult renal failure patients undergoing peritoneal dialys
    Category
    Medical Device
    Distribution
    0 states
  • SevereFDA (Drugs)·D-0957-2017·2017-07-19

    Baxter Recalls Sodium Chloride Injection Bags Due to Sterility Concerns

    Baxter Healthcare is recalling 0.9% Sodium Chloride Injection bags due to customer complaints about leaking bags, which raises concerns about the product's sterility.

    Product
    SODIUM CHLORIDE — SODIUM CHLORIDE (SODIUM CHLORIDE)
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-0972-2017·2017-07-19

    Baxter Recalls 5% Dextrose Injection Due to Sterility Concerns

    Baxter Healthcare is recalling 54,528 bags of 5% Dextrose Injection because the bags may leak, compromising sterility.

    Product
    DEXTROSE — DEXTROSE (DEXTROSE MONOHYDRATE)
    Category
    Drug
    Distribution
    Distributed nationwide
  • HighFDA (Drugs)·D-0973-2017·2017-07-19

    Baxter Recalls Sodium Chloride Injection Bags Due to Sterility Concerns

    Baxter Healthcare is recalling 295,200 bags of 0.9% Sodium Chloride Injection due to a lack of assurance of sterility and potential for leaking.

    Product
    SODIUM CHLORIDE — SODIUM CHLORIDE (SODIUM CHLORIDE)
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-2246-2017·2017-06-14

    Baxter MiniCap PD Transfer Set Recalled for Connection Leak Risk

    Baxter Healthcare is recalling MiniCap Extended Life PD Transfer Sets because connection issues may cause leaks and contamination, potentially leading to peritonitis.

    Product
    Baxter MiniCap Extended Life PD Transfer Set with Twist Clamp - Extra Short. 1 Unit. Sterile. Baxter Healthcare Corporation, Deerfield, IL 60015 USA
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-0789-2017·2017-05-24

    Baxter Recalls Milrinone Lactate Injection Due to Sterility Concerns

    Baxter Healthcare is recalling Milrinone Lactate in Dextrose Injection because customer complaints reported leaks, creating a lack of assurance of sterility.

    Product
    MILRINONE LACTATE IN DEXTROSE — MILRINONE LACTATE IN DEXTROSE (MILRINONE LACTATE)
    Category
    Drug
    Distribution
    0 states
  • ModerateFDA (Devices)·Z-1693-2017·2017-04-05

    Baxter SIGMA Spectrum Infusion Pump Software Anomaly Recall

    Baxter is recalling SIGMA Spectrum Infusion Pumps with Master Drug Library due to a software anomaly that may cause a Sharp Watchdog Timeout error.

    Product
    Baxter SIGMA Spectrum Infusion Pump with Master Drug Library, Model #/Product Code 35700BAX2
    Category
    Medical Device
    Distribution
    1 state
  • HighFDA (Devices)·Z-1095-2017·2017-02-01

    Baxter Recalls Phoenix Dialysis Machine Preventive Maintenance Kits

    Baxter Healthcare is recalling Phoenix Dialysis Machine Preventive Maintenance Kits due to incorrect silicone connectors that may cause fluid leaks.

    Product
    Maintenance Kit PH2, Cod. 6997274 The Phoenix Hemodialysis delivery system is intended to be used to provide high flux and low flux hemodialysis, hemofiltration and ultrafiltration on patients weighing 15 Kilograms or more. The Phoenix system is to be used with either high or lo
    Category
    Medical Device
    Distribution
    Distributed nationwide

About this company

Community-sourced company facts from Wikidata, not from any recall agency. This is background on the corporate entity — it says nothing about the recall(s) listed on this page, which come from the agency source notice above.

Baxter Healthcare Corporation

business enterprise in United States of America

Country
United States

Source: Wikidata (Q45134864), licensed CC0. Wikidata is community-edited and may not reflect the current corporate structure.