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.

351–375 of 432

  • ModerateFDA (Devices)·Z-1686-2020·2020-04-15

    Baxter Recalls GEM Microvascular Couplers Due to Labeling Mismatch

    Baxter Healthcare is recalling 209 GEM Microvascular Anastomotic Coupler Devices because the size labeling on the outer tray may not match the inner tray.

    Product
    GEM Microvascular Anastomotic Coupler Devices - Product Usage: s intended to be used in the anastomosis of veins and arteries normally encountered in microsurgical procedures only in the peripheral vascular system.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1685-2020·2020-04-15

    Baxter Recalls GEM Microvascular Couplers Due to Labeling Mismatch

    Baxter Healthcare is recalling GEM Microvascular Anastomotic Coupler Devices because the size labeling on the outer tray may not match the inner tray.

    Product
    GEM Microvascular Anastomotic Coupler Devices - Product Usage: is intended to be used in the anastomosis of veins and arteries normally encountered in microsurgical procedures only in the peripheral vascular system.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1687-2020·2020-04-15

    Baxter Recalls GEM Microvascular Couplers Due to Labeling Mismatch

    Baxter Healthcare is recalling GEM Microvascular Anastomotic Coupler Devices because the size labeling on the outer tray may not match the inner tray.

    Product
    GEM Microvascular Anastomotic Coupler Devices s intended to be used in the anastomosis of veins and arteries normally encountered in microsurgical procedures only in the peripheral vascular system.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1409-2020·2020-03-11

    Baxter Recalls Revaclear 300 Dialyzers Due to Potential Foreign Matter

    Baxter Healthcare is recalling Revaclear 300 Capillary Dialyzers because of the potential presence of particular matter in the header caps of ten lots.

    Product
    Revaclear Capillary Dialyzer 300, REF Revaclear 300 Product Code 114745L
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0793-2020·2020-01-15

    Baxter Recalls Clearlink Continu-Flo Administration Sets Due to Connection Force Issue

    Baxter Healthcare is recalling Clearlink System Continu-Flo Administration Sets because some units require higher-than-expected force to connect securely.

    Product
    Clearlink System Continu-Flo Administration Sets, Product Codes: 2C8519, 2C8537, and 2C8541 - Product Usage:For the administration of fluids from a container into the patients vascular system through a vascular access device.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0794-2020·2020-01-15

    Baxter Recalls One-Link Needle-Free IV Connectors Due to Connection Force Issue

    Baxter Healthcare is recalling One-Link Needle-Free IV Connectors because some units require higher-than-expected force to connect securely to standard Luer adapters.

    Product
    ONE-LINK Needle-free IV Connector, Product Codes: 7N8300, 7N8301, 7N8310, 7N8330K, 7N8332K, 7N8334K, 7N8370K, 7N8371, 7N8375K, 7N8376K, 7N8377, 7N8378, 7N8390, 7N8391, 7N8399 - Product Usage: intended for single patient use with a vascular access device for the administration of
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-0279-2020·2019-11-13

    Baxter Prismaflex Control Unit Software Recall for Therapy Interruption Risk

    Baxter is recalling Prismaflex Control Units with software below version 7.21 due to communication errors that may interrupt therapy or cause blood loss.

    Product
    Prismaflex Control Unit, software versions below 7.21
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-0276-2020·2019-11-13

    Baxter Prismaflex Control Unit Recalled for Communication Error Alarms

    Baxter Healthcare is recalling Prismaflex Control Units with software versions below 7.21 because communication error alarms may interrupt therapy or cause blood loss.

    Product
    Prismaflex Control Unit, software versions below 7.21
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-0278-2020·2019-11-13

    Baxter Prismaflex Control Unit Software Recall for Therapy Interruption Risk

    Baxter is recalling Prismaflex Control Units with software below version 7.21 due to communication errors that may interrupt therapy or cause blood loss.

    Product
    Prismaflex Control Unit, software versions below 7.21
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-0277-2020·2019-11-13

    Baxter Prismaflex Control Unit Recalled for Potential Therapy Interruption

    Baxter Healthcare is recalling Prismaflex Control Units with software below version 7.21 due to communication errors that may interrupt therapy or cause blood loss.

    Product
    Prismaflex Control Unit, software versions below 7.21
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0280-2020·2019-11-13

    Baxter Prismaflex Control Unit Recalled for Communication Error Alarms

    Baxter Healthcare is recalling 336 Prismaflex Control Units with software versions below 7.21 due to communication error alarms that may interrupt therapy or cause blood loss.

    Product
    Prismaflex Control Unit, software versions below 7.21
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0167-2020·2019-10-30

    Baxter Recalls EXACTAMIX Empty EVA TPN Bags Due to Leak Risk

    Baxter Healthcare is recalling EXACTAMIX Empty EVA TPN bags because they may leak after being used for compounding sterile solutions.

    Product
    EXACTAMIX Empty EVA (Ethylene Vinyl Acetate) TPN Bag with the following product code and sizes: 1. H938737, 250mL; 2. H938738, 500mL; 3. H938739, 1000mL; 4. H938740, 2000mL; 5. H938741, 3000mL Product Usage: The EXACTAMIX Empty EVA bags are used as the des
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0050-2020·2019-10-16

    Baxter Recalls Exactamed Oral Dispensers Due to Mixed Sizes

    Baxter Healthcare is recalling Exactamed 5 mL Oral Dispensers because pharmacy packs may contain 3 mL dispensers, risking inaccurate dosing.

    Product
    EXACTAMED Oral Dispensers, 5mL, AMBER: (a) PHARMACY PACK, REF H9388105, x 100; (b) PHARMACY PACK, REF H9388505, x 500; (c) COST CONTAINMENT, REF H93884205, x 1500 - Product Usage: Oral Liquid Dispensers are intended for the accurate dose measurement and clean intermittent adminis
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0030-2020·2019-10-09

    Baxter Integrated APD Set Recalled for Potential Cassette Leaks

    Baxter Healthcare is recalling L5C4531 X1 Integrated APD Sets because cassettes may leak, risking sterile fluid path contamination and peritonitis.

    Product
    L5C4531 X1 Integrated APD Set with Cassette 3-Prong Sterile, nonpyrogenic fluid path. Sterilized by ethylene oxide.
    Category
    Medical Device
    Distribution
    13 states
  • ModerateFDA (Devices)·Z-2432-2019·2019-09-04

    Baxter Recalls Exactamed Oral Dispensers Due to Mixed Sizes

    Baxter Healthcare is recalling Exactamed 5 mL Oral Dispensers because pharmacy packs may contain 10 mL dispensers.

    Product
    EXACTAMED Oral Dispensers, 5mL, AMBER: PHARMACY PACK, REF H9388505, x500 PHARMACY PACK, REF H9388105, x100 COST CONTAINMENT, REF H93884205, x1500
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Drugs)·D-1514-2019·2019-07-31

    Baxter Recalls Sodium Chloride Injection Due to Sterility Concerns

    Baxter Healthcare is recalling 139,680 containers of 0.9% Sodium Chloride Injection due to a lack of assurance of sterility and potential for bags to leak.

    Product
    SODIUM CHLORIDE — SODIUM CHLORIDE (SODIUM CHLORIDE)
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-1908-2019·2019-07-10

    Baxter Recalls Revaclear 300 Dialyzers Due to Potential Fiber Rupture

    Baxter Healthcare is recalling Revaclear 300 dialyzers because ruptured fibers may cause blood leaks during hemodialysis treatment.

    Product
    REVACLEAR 300 Dialyzer, Product Code 114745L Revaclear 300 and Revaclear 400 dialyzers are indicated for treatment of chronic and acute renal failure by hemodialysis.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1909-2019·2019-07-10

    Baxter Recalls Revaclear 400 Dialyzers Due to Potential Fiber Rupture

    Baxter Healthcare is recalling Revaclear 400 dialyzers because ruptured fibers may cause blood leaks during hemodialysis treatment.

    Product
    REVACLEAR 400 Dialyzer, Product Code 114746L Revaclear 300 and Revaclear 400 dialyzers are indicated for treatment of chronic and acute renal failure by hemodialysis.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-1248-2019·2019-05-08

    Baxter SIGMA Spectrum Infusion Pumps Recalled for Flow Rate Testing Errors

    Baxter Healthcare is recalling 158 SIGMA Spectrum Infusion Pumps because flow rate tests were performed for less than the required time, potentially leading to inaccurate fluid administration.

    Product
    Baxter SIGMA Spectrum Infusion Pump with Master Drug Library (Version 6), product code 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 include pharmaceu
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-0850-2019·2019-02-27

    Baxter Recalls Kaguya Automated Peritoneal Dialysis Systems Due to Software Defect

    Baxter Healthcare is recalling 1,085 Kaguya Automated Peritoneal Dialysis Systems because a software defect may cause shortened dwell times during therapy.

    Product
    Kaguya Automated Peritoneal Dialysis System Product Usage: It is intended for automatic control of dialysate solution exchanges in the treatment of adult renal failure patients undergoing Peritoneal dialysis.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0849-2019·2019-02-27

    Baxter AMIA Automated Peritoneal Dialysis System Software Recall

    Baxter is recalling 7,688 AMIA Automated Peritoneal Dialysis Systems due to a software defect that may cause shortened dwell times during therapy.

    Product
    AMIA Automated Peritoneal Dialysis System Product Usage: It is intended for automatic control of dialysate solution exchanges in the treatment of adult renal failure patients undergoing Peritoneal dialysis.
    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.