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.

301–325 of 432

  • HighFDA (Devices)·Z-0575-2022·2022-02-16

    Baxter MiniCap PD Transfer Set Recall—Damage from Cleaning Products

    Baxter Healthcare is recalling MiniCap Extended Life PD Transfer Sets worldwide because cleaning products containing hydrogen peroxide, bleach, alcohol, or solvents may cause the devices to leak or crack.

    Product
    Baxter MiniCap Extended Life PD Transfer Set with Twist Clamp, REF R5C4482
    Category
    Medical Device
    Distribution
    0 states
  • HighFDA (Devices)·Z-0571-2022·2022-02-16

    Baxter MiniCap PD Transfer Sets Recalled for Chemical Damage Risk

    Baxter Healthcare is recalling 2,553,528 units of the MiniCap Extended Life PD Transfer Set worldwide because cleaning products containing certain chemicals may cause the device to leak or crack.

    Product
    Baxter MiniCap Extended Life PD Transfer Set with Twist Clamp, 5C4482
    Category
    Medical Device
    Distribution
    0 states
  • SevereFDA (Devices)·Z-0529-2022·2022-02-09

    Baxter Spectrum IQ Infusion Pumps Recalled Due to Potential Medication Delivery Failure

    Baxter Healthcare is recalling 241,304 Spectrum IQ infusion pumps due to potential medication delivery failure without user alert. The issue may occur during administration set setup or when occlusion alarms are not fully resolved.

    Product
    Baxter Spectrum IQ Infusion Pumps, Product code 3570009.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-0530-2022·2022-02-09

    Baxter SIGMA Spectrum infusion pumps recalled for medication delivery failures

    Baxter is recalling 146,502 SIGMA Spectrum infusion pumps due to potential medication delivery failures that may occur without alerting clinicians. The issue is linked to administration set setup and occlusion alarm resolution.

    Product
    Baxter SIGMA Spectrum Infusion Pump with Master Drug Library (Version 8), Product code 35700BAX2.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0215-2022·2021-11-17

    Hemodialysis Delivery System Software May Use Incorrect Treatment Parameters

    Baxter's Hemodialysis Delivery System may incorrectly revert to old prescription values when operators change prescriptions after filter changes, potentially resulting in incorrect treatment parameters.

    Product
    Hemodialysis Delivery System, Software Version 2.x.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2378-2021·2021-09-08

    Baxter PrismaFlex Dialysis Tubing Sets Recalled Due to Sterilization Failure

    Baxter PrismaFlex dialysis tubing sets are being recalled because products labeled sterile may not have been properly sterilized due to sterilization contractor failures and data integrity issues.

    Product
    Baxter PrismaFlex, REF numbers: a) 106696 (M 60 SET) b) 106697 (M 100 SET) Expansion: c) 107144 (TPE2000 SET) d) 115307 (M 150 SET) e) 115309 (ST 100 SET) f) 955467 (M 150 SET) g) 955468 (ST 100 SET) h) 955595 (M 100 SET) i) 955596 (ST 150 SET) Used with Prismafl
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2379-2021·2021-09-08

    Baxter Prismaflex Dialysis Membranes Recalled for Sterilization Failure

    Baxter is recalling Prismaflex HF 1000 dialysis membranes (Lot 20B2330M) because products labeled as sterile may not have been properly sterilized due to manufacturing defects and data manipulation. Non-sterile devices could pose infection risks to patients.

    Product
    Baxter prismaflex, HF 1000 PAES membrane, REF 107140 Used with Prismaflex or PrisMax control units for continuous fluid management and renal replacement therapies.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-2110-2021·2021-08-18

    Spectrum IQ Infusion System Recalled for Connectivity Errors

    Baxter Healthcare Corporation is recalling the Spectrum IQ Infusion System due to system errors causing pump connectivity failures following certain network configuration changes.

    Product
    Spectrum IQ Infusion System with Dose IQ Safety Software, Product Code 3570009. for the controlled administration of fluids.
    Category
    Medical Device
    Distribution
    1 state
  • SevereFDA (Devices)·Z-2165-2021·2021-08-18

    Spectrum IQ Infusion Pump Safety Software Recalled for Drug Identifier Mismatch

    Baxter is recalling Dose IQ Safety Software for Spectrum IQ Infusion Pumps due to a software defect that creates a mismatch between displayed drug names and the device's drug library. This could lead to incorrect medication administration.

    Product
    Dose IQ Safety Software used with Spectrum IQ Infusion Pump
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2174-2021·2021-08-11

    AMIA Automated Peritoneal Dialysis System User Guide Contains Incorrect Operating Instructions

    The AMIA Sharesource User Guide for the AMIA Automated Peritoneal Dialysis System incorrectly describes the Ultrafiltration Limit setting, potentially causing patients to misunderstand when therapy should end. Approximately 5,101 affected units have been distributed worldwide.

    Product
    Kaguya Automated Peritoneal Dialysis System
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-2173-2021·2021-08-11

    Amia Automated PD System User Guide Incorrectly Describes Ultrafiltration Limit Function

    Baxter's user guide for the Amia Automated PD System incorrectly describes how the Ultrafiltration Limit setting controls the Extra Last Drain Mode. This documentation error could affect patients' ability to properly end therapy sessions.

    Product
    Sharesource Connectivity Platform for Use with the Amia Automated PD System
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-2051-2021·2021-07-21

    Medical device recall: EASYGRIP FLO-41 barcode expiration date discrepancy

    Baxter Healthcare Corporation is recalling 4,752 units of EASYGRIP FLO-41 hemostatic delivery devices due to a discrepancy between the expiration date encoded in the 2D barcode and the human-readable date on the product.

    Product
    EASYGRIP FLO-41 US. For delivering hemostatic agents to bleeding sites through a trocar.
    Category
    Medical Device
    Distribution
    0 states
  • HighFDA (Devices)·Z-1684-2021·2021-06-02

    Baxter Gambro Cartridge Blood Set Recalled for Potential Leak Risk

    Baxter Healthcare is recalling Gambro Cartridge Blood Sets due to a potential leak between the venous patient connector and the patient's hemodialysis access.

    Product
    Gambro Cartridge Blood Set, Product Code 101025 - Product Usage: intended for single use in a hemodialysis treatment using the Phoenix Dialysis Delivery Systems.
    Category
    Medical Device
    Distribution
    0 states
  • HighFDA (Devices)·Z-1487-2021·2021-05-05

    Baxter Spectrum IQ Infusion Pump Recalled for Defective AC Power Adapter

    Baxter Healthcare is recalling 408 Spectrum IQ infusion pumps because a potentially defective AC power adapter may fail over time.

    Product
    Spectrum IQ - Infusion Pump - Product Usage: intended to be used for the controlled administration of fluids.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-1280-2021·2021-03-31

    Baxter Recalls Prismaflex Preventative Maintenance Kits Due to Tubing Performance Variability

    Baxter Healthcare is recalling Prismaflex Preventative Maintenance Kits and spare part kits because tubing performance variability may cause alarms during or after system self-tests.

    Product
    Preventative Maintenance Kits G5010007) and spare part kits (G5064801 and G5006203) - Product Usage: For Prismaflex Control Units, used for Continuous Renal Replacement Therapy (CRRT).
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1278-2021·2021-03-31

    Baxter Recalls Prismaflex Control Units Due to Tubing Performance Variability

    Baxter Healthcare is recalling 1,225 Prismaflex Control Units used for Continuous Renal Replacement Therapy because tubing performance variability may cause alarms during or after system self-tests.

    Product
    Prismaflex Control Unit - Product Usage: Used for Continuous Renal Replacement Therapy (CRRT).
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1279-2021·2021-03-31

    Baxter Recalls Prismaflex Control Units Due to Tubing Performance Variability

    Baxter Healthcare is recalling 1,650 Prismaflex Control Units used for renal replacement therapy because tubing performance variability may cause alarms during or after system self-tests.

    Product
    Prismaflex Control Unit - Product Usage: Used for Continuous Renal Replacement Therapy (CRRT).
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1277-2021·2021-03-31

    Baxter Recalls Prismaflex Control Units Due to Tubing Performance Variability

    Baxter Healthcare is recalling Prismaflex Control Units because tubing variability may cause alarms during self-tests. The units are used for Continuous Renal Replacement Therapy.

    Product
    Prismaflex Control Unit - Product Usage: Used for Continuous Renal Replacement Therapy (CRRT).
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1151-2021·2021-03-10

    Baxter Recalls PrisMax Hemodialysis Tubing Due to Performance Variability

    Baxter Healthcare is recalling PrisMax System Version II hemodialysis tubing due to performance variability that may cause alarms and therapy interruptions.

    Product
    The PrisMax System Version II Hemodialysis Delivery System: Automatic Repositioning System Pump Assembly, specifically tubing, Model Numbers: a) 955626 b) 955558 c) 955701 PrisMax V2 Preventive Maintenance Kit, Product Code SC616 ARPS PUMP, Product Code SC6035 ARPS Pump As
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1121-2021·2021-02-24

    Baxter Gambro Cartridge Blood Transport System Recalled for Kinked Lines

    Baxter Healthcare is recalling Gambro Cartridge Blood Transport Systems for hemodialysis due to reports of kinked access lines observed during treatment.

    Product
    Gambro Cartridge Blood Transport System for Hemodialysis Blood Set, product code 109536 - Product Usage: intended for single use in a hemodialysis treatment using the Phoenix Dialysis Delivery Systems.
    Category
    Medical Device
    Distribution
    0 states
  • HighFDA (Devices)·Z-1118-2021·2021-02-24

    Baxter Gambro Cartridge Blood Set Prime Line Recalled for Kinked Lines

    Baxter Healthcare is recalling Gambro Cartridge Blood Set Prime Line units because kinked access lines were observed during hemodialysis treatments.

    Product
    Gambro Cartridge Blood Set Prime Line, product code 101025 - Product Usage: intended for single use in a hemodialysis treatment using the Phoenix Dialysis Delivery Systems.
    Category
    Medical Device
    Distribution
    0 states
  • HighFDA (Devices)·Z-1119-2021·2021-02-24

    Baxter Gambro Cartridge Single Needle Conversion Kit Recalled for Kinked Lines

    Baxter Healthcare is recalling Gambro Cartridge Single Needle Conversion Kits due to reports of kinked access lines during hemodialysis treatments.

    Product
    Gambro Cartridge Single Needle Conversion Kit, product code 101290 - Product Usage: intended for single use in a hemodialysis treatment using the Phoenix Dialysis Delivery Systems.
    Category
    Medical Device
    Distribution
    0 states
  • HighFDA (Devices)·Z-1123-2021·2021-02-24

    Baxter Recalls Gambro Hemodialysis Blood Sets Due to Kinked Lines

    Baxter Healthcare is recalling Gambro Cartridge Low Weight-Low Volume Blood Transport Systems for hemodialysis because of complaints regarding kinked access lines observed during treatment.

    Product
    Gambro Cartridge Low Weight-Low Volume Blood Transport System for Hemodialysis Blood Set, product code 114435 - Product Usage: intended for single use in a hemodialysis treatment using the Phoenix Dialysis Delivery Systems.
    Category
    Medical Device
    Distribution
    0 states
  • HighFDA (Devices)·Z-1120-2021·2021-02-24

    Baxter Gambro Cartridge Blood Transport System Recalled for Kinked Lines

    Baxter Healthcare is recalling Gambro Cartridge Blood Transport Systems for hemodialysis due to complaints of kinked access lines observed during treatment.

    Product
    Gambro Cartridge Blood Transport System for Hemodialysis Blood Set, product code 106289 - Product Usage: intended for single use in a hemodialysis treatment using the Phoenix Dialysis Delivery Systems.
    Category
    Medical Device
    Distribution
    0 states

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.