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.

326–350 of 432

  • HighFDA (Devices)·Z-1122-2021·2021-02-24

    Baxter Gambro Hemodialysis Blood Set Recalled for Kinked Access Lines

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

    Product
    Gambro Cartridge Low Volume Blood Transport System for Hemodialysis Blood Set, product code 114434 - 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-1102-2021·2021-02-17

    Baxter IV Catheter Extension Set Recalled for Tubing Separation

    Baxter Healthcare is recalling 66,800 units of ONE-LINK Non-DEHP Y-Type Microbore Catheter Extension Sets due to reports of tubing separation from the Male Luer Lock Adaptor.

    Product
    Baxter ONE-LINK Non-DEHP Y-Type Microbore Catheter Extension Set, Bonded Needle-free IV Connector, Neutral Fluid Displacement, 5.7 " (14 cm), REF 7N8370K - Product Usage: intended for single patient use with a vascular access device for the administration of drugs and solutions w
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0939-2021·2021-02-10

    Baxter Flow Coupler Monitor Recall Due to Battery Recharge Failure

    Baxter Healthcare is recalling 109 Flow Coupler Monitor devices because the battery may lose its ability to be recharged.

    Product
    FLOW COUPLER Monitor Flow Coupler devices are sold in 5 sizes (2.0 mm, 2.5 mm, 3.0 mm, 3.5 mm, 4.0 mm). Implantable device for vascular use.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0807-2021·2021-01-20

    Baxter Recalls VERITAS Collagen Matrix Patches Due to Undersized Width

    Baxter Healthcare is recalling 192 units of VERITAS Collagen Matrix patches because they may have undersized width dimensions. The recall covers US and international distribution.

    Product
    VERITAS Collagen Matrix - Product Usage: intended for use in reconstruction of the pelvic floor excluding transvaginal pelvic organ prolapse and for use in the repair of rectal prolapse excluding rectocele.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0768-2021·2021-01-13

    Baxter MiniCap Extended Life PD Transfer Set Recalled for Leak Risk

    Baxter Healthcare is recalling 72,771 units of MiniCap Extended Life PD Transfer Sets due to a potential for no-flow and leaks under the twist clamp.

    Product
    MiniCap Extended Life PD Transfer Set
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0712-2021·2020-12-30

    Baxter SIGMA Spectrum Infusion Pump Recalled for Potential Software Error

    Baxter Healthcare is recalling 9,353 SIGMA Spectrum Infusion Pumps due to a potential software error during programming.

    Product
    Baxter SIGMA Spectrum Infusion Pump with Master Drug Library (Version 6) - Product Usage: intended to be used for the controlled administration of fluids.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0714-2021·2020-12-30

    Baxter SIGMA Spectrum Infusion Pump Recalled for Potential Software Error

    Baxter Healthcare is recalling 140,006 SIGMA Spectrum Infusion Pumps due to a potential software error during programming.

    Product
    Baxter SIGMA Spectrum Infusion Pump with Master Drug Library (Version 8) - Product Usage: intended to be used for the controlled administration of fluids.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0713-2021·2020-12-30

    Baxter SIGMA Spectrum Infusion Pump Recalled for Potential Software Error

    Baxter Healthcare is recalling SIGMA Spectrum Infusion Pumps due to a potential software error during programming.

    Product
    Baxter SIGMA Spectrum Infusion Pump with Master Drug Library (Version 6) - Product Usage: intended to be used for the controlled administration of fluids.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0715-2021·2020-12-30

    Baxter Spectrum IQ Infusion System Recalled for Potential Software Error

    Baxter Healthcare is recalling Spectrum IQ Infusion Systems with Dose IQ Safety Software due to a potential software error during programming.

    Product
    Baxter Spectrum IQ Infusion System with Dose IQ Safety Software - Product Usage: intended to be used for the controlled administration of fluids.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-0076-2021·2020-11-18

    Baxter Recalls Bupivacaine Injection Due to Particulate Matter

    Baxter Healthcare is recalling specific lots of Bupivacaine Hydrochloride Injection due to the presence of black and transparent particles in the solution.

    Product
    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 Healthcare Corporation Deerfield, IL 60015 USA, Manufactured by: Baxter Pharmaceuticals India Private Ltd Ahmedabad 382213 India,
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-0122-2021·2020-10-28

    Baxter SIGMA Spectrum Infusion Pump Recall for Safety Communication Update

    Baxter Healthcare is recalling 152,539 SIGMA Spectrum Infusion Pumps to update the Instructions for Use (IFU) regarding cleaning practices.

    Product
    Baxter SIGMA Spectrum Infusion Pump with Master Drug Library (Version 8)
    Category
    Medical Device
    Distribution
    1 state
  • LowFDA (Devices)·Z-0120-2021·2020-10-28

    Baxter SIGMA Spectrum Infusion Pump IFU Update for Cleaning Practices

    Baxter is updating the Instructions for Use for the SIGMA Spectrum Infusion Pump to clarify safety communication regarding cleaning practices.

    Product
    Baxter SIGMA Spectrum Infusion Pump with Master Drug Library (Version 6)
    Category
    Medical Device
    Distribution
    1 state
  • HighFDA (Devices)·Z-2474-2020·2020-07-08

    Baxter GEM Flow Coupler Monitor Recalled for Firmware Shutdown Issue

    Baxter Healthcare is recalling 60 units of the GEM Flow Coupler Monitor because a firmware issue may cause intermittent shutdowns when WiFi is not connected.

    Product
    Flow Coupler Monitor, GEM, Global Excellence Microsurgery, Rx Only
    Category
    Medical Device
    Distribution
    19 states
  • HighFDA (Devices)·Z-2194-2020·2020-06-10

    Baxter Gambro Cartridge Blood Transport System Recalled for Tubing Disconnection Risk

    Baxter Healthcare is recalling Gambro Cartridge Blood Transport Systems due to a potential disconnection of the tubing set. The recall covers 53,895 units distributed worldwide.

    Product
    Gambro Cartridge Blood Transport System for Hemodialysis Blood Set - Product Usage: is intended for single use in a hemodialysis treatment using Dialysis Delivery Systems.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2196-2020·2020-06-10

    Baxter Gambro Hemodialysis Blood Set Recalled for Tubing Disconnection Risk

    Baxter Healthcare is recalling 4,065 Gambro Cartridge Low Weight-Low Volume Blood Transport Systems due to a potential tubing disconnection hazard.

    Product
    Gambro Cartridge Low Weight-Low Volume Blood Transport System for Hemodialysis Blood Set - Product Usage: is intended for single use in a hemodialysis treatment using Dialysis Delivery Systems.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2195-2020·2020-06-10

    Baxter Gambro Hemodialysis Blood Set Recalled for Tubing Disconnection Risk

    Baxter Healthcare is recalling 19,800 Gambro Cartridge Low Volume Blood Transport Systems due to a potential tubing disconnection hazard.

    Product
    Gambro Cartridge Low Volume Blood Transport System for Hemodialysis Blood Set - Product Usage: is intended for single use in a hemodialysis treatment using Dialysis Delivery Systems.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2193-2020·2020-06-10

    Baxter Gambro Cartridge Blood Set Recalled for Tubing Disconnection Risk

    Baxter Healthcare is recalling Gambro Cartridge Blood Sets due to a potential tubing disconnection hazard during hemodialysis treatment.

    Product
    Gambro Cartridge Blood Set Prime Line - Product Usage: is intended for single use in a hemodialysis treatment using Dialysis Delivery Systems.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-2066-2020·2020-05-27

    Baxter Recalls Prismaflex Control Units Lacking FDA Clearance

    Baxter Healthcare is recalling five Prismaflex Control Units distributed to Puerto Rico and Guam because they lack FDA regulatory clearance.

    Product
    Prismaflex Control Unit
    Category
    Medical Device
    Distribution
    2 states
  • ModerateFDA (Devices)·Z-1830-2020·2020-05-06

    Baxter Prismaflex System Safety Communication on Connector Use

    Baxter issued a safety communication regarding the proper use of connectors with the Prismaflex System and Control Unit.

    Product
    Prismaflex System, Prismaflex Control Unit
    Category
    Medical Device
    Distribution
    1 state
  • ModerateFDA (Devices)·Z-1833-2020·2020-05-06

    Baxter Prismaflex System Recall for Connector Usage Safety Information

    Baxter Healthcare is issuing a Class II recall for 133 Prismaflex Systems to communicate safety information regarding the proper use of connectors.

    Product
    Prismaflex System, Prismaflex Control Unit
    Category
    Medical Device
    Distribution
    1 state
  • ModerateFDA (Devices)·Z-1829-2020·2020-05-06

    Baxter Prismaflex System Recall for Connector Safety Information

    Baxter is recalling 1,225 Prismaflex Systems to communicate safety information regarding the proper use of connectors.

    Product
    Prismaflex System, Prismaflex Control Unit
    Category
    Medical Device
    Distribution
    1 state

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.