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.

151–175 of 432

  • HighFDA (Devices)·Z-2582-2024·2024-08-28

    Spectrum Wireless Battery Modules fail to auto-document infusion status

    Spectrum Wireless Battery Modules may fail to send infusion status updates to hospital electronic medical records. The issue affects 17,377 units nationwide used with Spectrum V8 and IQ infusion pumps.

    Product
    Spectrum Wireless Battery Modules A/B/G/N, product code 36010, used with either of the following 35700BAX2 (Spectrum V8 infusion pump) and 3570009 (Spectrum IQ infusion pump)
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2581-2024·2024-08-28

    Baxter Spectrum Wireless Battery Modules May Fail to Document Infusion Status

    Baxter Spectrum Wireless Battery Modules may fail to automatically transmit infusion status information to hospital electronic medical records systems. The software issue affects 17,377 units nationwide.

    Product
    Baxter Spectrum Wireless Battery Modules A/B/G/N, product code 35223, used with either of the following: 35700BAX2 (Spectrum V8 infusion pump) or 3570009 (Spectrum IQ infusion pump) Baxter SIGMA Spectrum V8 Infusion Pump
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2512-2024·2024-08-14

    Baxter Precision Surgical Table Recall: Loose Spring Pins Risk

    Baxter Healthcare Corporation is recalling the PST 500 U Precision Surgical Table due to loose spring pins that can cause the tabletop to unexpectedly tilt or move, potentially causing unintended patient movement during surgery.

    Product
    Baxter PST 500 U, Precision Surgical Table, Part number (product code) 4080300
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2530-2024·2024-08-14

    Baxter SIGMA Spectrum Infusion Pump recall due to inadequate pre-release testing

    Baxter Healthcare is recalling the SIGMA Spectrum Infusion Pump (Serial 2158913) distributed nationwide in Florida. The recall is due to improperly performed testing procedures prior to release, which may affect device function.

    Product
    Baxter SIGMA Spectrum Infusion Pump, Product Code: 35700BAX2
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-2321-2024·2024-07-24

    Ventilation Device Handset Plug May Disconnect from Nebulizer Adapter

    Baxter's Volara System SPU circuit kits may have a faulty handset plug that disconnects from the nebulizer adapter, preventing proper ventilator gas flow.

    Product
    Volara System. Single Patient Use (SPU) Circuit 5kit for Volara and Single Patient Use (SPU) Circuit kit for Volara. Intermittent positive pressure breathing device.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-2322-2024·2024-07-24

    Volara System Blue Ventilator Adapter Module Handset Plug Disconnection

    Baxter Healthcare is recalling 350 units of the Volara System Blue Ventilator Adapter Module because the handset plug may disconnect from the nebulizer port, disrupting ventilator gas flow. Affected units were distributed nationwide and internationally.

    Product
    Volara System. Blue Ventilator Adapter Module. Intermittent positive pressure breathing device component.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-2313-2024·2024-07-17

    Baxter VidiaPort and Trulight surgical lights recalled for thermal burn risk

    Baxter Healthcare Corporation is recalling VidiaPort and Trulight surgical light systems due to customer reports of thermal skin injuries. Approximately 275 units were distributed worldwide.

    Product
    VidiaPort carrying arm, mount for auxiliary products, model numbers: a) 4028110 (Ceiling Single Surgical Light); b) 4028210 (Ceiling Duo Surgical Lights); c) 4028310 (Ceiling Trio Surgical Lights)
    Category
    Medical Device
    Distribution
    0 states
  • SevereFDA (Devices)·Z-2315-2024·2024-07-17

    Baxter iLED 7 surgical lights recalled due to thermal burn risk

    Baxter Healthcare is recalling iLED 7 surgical lights due to customer reports of thermal skin injuries. The recall affects approximately 6,243 units distributed worldwide.

    Product
    iLED 7 surgical lights, Model Numbers: a) 4068110 (Ceiling Single Surgical Light); b) 4068120 (Mobile Surgical Light); c) 4068140 (Pendant Surgical Light); d) 4068210 (Ceiling Duo Surgical Lights); e) 4068310 (Ceiling Trio Surgical Lights); f) 4068410 (Ceiling Quad
    Category
    Medical Device
    Distribution
    0 states
  • SevereFDA (Devices)·Z-2314-2024·2024-07-17

    Baxter Trulight Surgical Lights Recalled for Thermal Skin Injuries

    Baxter Healthcare Corporation recalled Trulight 5000/3000 Surgical Light systems due to customer reports of thermal skin injuries. The urgent medical device correction affects models 4038210 and 4038310 distributed worldwide.

    Product
    Trulight 5000/3000 Surgical Light, model numbers: a) 4038210 (Duo Surgical Lights}; b) 4038310 (Trio/Quad Surgical Lights)
    Category
    Medical Device
    Distribution
    0 states
  • HighFDA (Drugs)·D-0587-2024·2024-07-17

    Dianeal Low Calcium Dialysis Solution Recall: Sterility Risk from Connector Leaks

    Baxter Healthcare recalls 6,874 bags of Dianeal Low Calcium peritoneal dialysis solution due to potential leaks in the connector assembly that could compromise product sterility.

    Product
    DIANEAL LOW CALCIUM WITH DEXTROSE — DIANEAL LOW CALCIUM WITH DEXTROSE (SODIUM CHLORIDE, SODIUM LACTATE, CALCIUM CHLORIDE, MAGNESIUM CHLORIDE AND DEXTROSE)
    Category
    Drug
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2323-2024·2024-07-17

    Welch Allyn CP150 Electrocardiograph recalled for missing electromagnetic interference absorber

    Baxter Healthcare is recalling the Welch Allyn CP150 Electrocardiograph because a critical manufacturing step—installation of an electromagnetic interference absorber—was omitted. This could cause device malfunction or interference with nearby medical equipment.

    Product
    Welch Allyn CP150 Electrocardiograph with Spirometry Option, Product Code: CP150A-1ENB. The Electrocardiograph is one of the tools that clinicians use to evaluate, diagnose, and monitor patient cardiac function.
    Category
    Medical Device
    Distribution
    1 state
  • ModerateFDA (Devices)·Z-2339-2024·2024-07-17

    Braun Thermoscan PRO 6000 Recall: Outdated Instructions on Included CD

    Braun Thermoscan PRO 6000 ear thermometers may have been shipped with outdated Instructions for Use on an included CD. Approximately 265,647 units were distributed globally.

    Product
    Braun Thermoscan¿ PRO 6000 Ear Thermometer
    Category
    Medical Device
    Distribution
    2 states
  • CriticalFDA (Devices)·Z-2140-2024·2024-07-03

    Life2000 Ventilator systems recalled due to battery charging failure risk

    The Life2000 Ventilator may fail to charge or experience intermittent charging behavior due to damage to the battery charger dongle. This FDA Class I recall affects approximately 2,510 units distributed nationwide.

    Product
    Life2000 Ventilator, Product Code: MS-01-0118, which is contained in the Life2000 Ventilator System, with Product Codes BT-20-0002, BT-20-0002A and BT-20-0002AP. The Life2000 ventilation system includes the Life2000 ventilator which has its individual label.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2151-2024·2024-06-26

    Hospital bed mattress covers may delaminate from improper cleaning

    Baxter Healthcare is recalling Centrella Max and Pro+ hospital bed mattresses that may develop delaminated top covers when cleaned with bleach-containing solutions. The mattresses prevent and treat pressure injuries.

    Product
    Centrella Max - The Centrella Smart+ Bed is intended for use in healthcare environments as a patient support system to prevent and/or treat pressure injuries.Multiple model numbers of Centrella Max mattresses and pro+ mattresses. (1) Centrella Max Surface, REF P7922A01; (2) C
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1810-2024·2024-05-22

    Baxter Spectrum IQ Infusion Pump Recalled for Potential Front Panel Cracks

    Baxter Healthcare Corporation has recalled 9 Spectrum IQ Infusion Pumps due to potential cracks on the front panel mount. Units distributed in Ohio and Wisconsin are affected.

    Product
    Spectrum IQ Infusion pump, Product Code 357009
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1775-2024·2024-05-15

    Baxter Spectrum IQ Infusion Pump recalled due to improper pre-release testing

    Baxter Healthcare is recalling one Spectrum IQ Infusion Pump that underwent improper testing before release. The device was distributed nationwide including in Massachusetts.

    Product
    Baxter Spectrum IQ Infusion Pump, Product Code 3570009
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1689-2024·2024-05-01

    Baxter Seprafilm Adhesion Barrier Recalled for Unapproved Distribution

    Baxter Healthcare is recalling Seprafilm Adhesion Barrier units (165 units, Lot DBYSEP046) that were distributed nationwide without FDA approval. Affected units distributed in LA, GA, IN, VA, FL, NY, and CA.

    Product
    Baxter Seprafilm Adhesion Barrier 1 Half Sheet, 5-PK, REF 664103, for use in abdominal and pelvic surgery
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1522-2024·2024-04-24

    Marketing brochures for Baxter surgical vessel occluders contain inaccurate information

    Baxter Healthcare is recalling marketing brochures for surgical vessel occluders and related devices because the brochures contain information that does not match the official product instructions for use.

    Product
    Surgical Tools and Cardiovascular Specialty marketing brochures, Reference numbers: US-AS18-210002 Surgical Tools Brochure 2021, US-AS18-210004 Surgical Tools Website v1, and US-AS46-230002 CV Specialty Brochure US version which affect: Flo-Rester Disposable Internal Vessel O
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1523-2024·2024-04-24

    Surgical and Cardiovascular Device Marketing Brochures Recalled for Documentation Errors

    Baxter Healthcare is recalling surgical and cardiovascular device marketing brochures that contain information conflicting with the official Instructions for Use. The inaccurate content could lead to incorrect device use.

    Product
    Surgical Tools and Cardiovascular Specialty marketing brochures, Reference numbers: US-AS18-210002 Surgical Tools Brochure 2021, US-AS18-210004 Surgical Tools Website v1, and US-AS46-230002 CV Specialty Brochure US version which affect: Flo-Thru Intraluminal Shunt, Item Numbe
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1524-2024·2024-04-24

    Baxter surgical tool marketing brochures contain inaccurate Instructions for Use

    Baxter Healthcare Corporation recalled marketing brochures for surgical tools that contain inaccurate information conflicting with the product Instructions for Use. Over 82,000 units were distributed worldwide.

    Product
    Surgical Tools and Cardiovascular Specialty marketing brochures, Reference numbers: US-AS18-210002 Surgical Tools Brochure 2021, US-AS18-210004 Surgical Tools Website v1, and US-AS46-230002 CV Specialty Brochure US version which affect: Vascular Probe, Item Numbers: a) 708101
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1511-2024·2024-04-17

    Baxter Power Cords Recalled for Electrical Insulation Non-Compliance

    Baxter Healthcare is recalling power cord models globally because the insulation does not meet electrical safety standards, creating a potential risk of electrical shock or fire.

    Product
    Power Cords, marketed under the following models: a) CORD,METAL EARTH PIN, 2.5A,250V,2.5M,C7, 714682; b) PLFM CLASS II POWER CORD - AUSTRALIA, 716010; c) PLFM CLASS II POWER CORD - EUROPE, 716012; d) POWER CORD,AUSTRALIA,2.5A,250V,2.5M,C7, 008-0910-00; e) POWER CORD,E
    Category
    Medical Device
    Distribution
    2 states
  • HighFDA (Devices)·Z-1509-2024·2024-04-17

    Medical Device Recall: Blood Pressure Monitors With Defective Power Cord Insulation

    Baxter Healthcare is recalling Connex ProBP 3400 blood pressure monitors due to power cord insulation defects that fail to meet electrical safety standards. Approximately 11,154 units are affected globally.

    Product
    Hillrom Welch Allyn Connex ProBP 3400 Digital Blood Pressure Device, marketed under the following models: a) PROBP 3400, SUREBP, BLUETOOTH, MOBILE,EU, Product Code 34BFST-2; b) PROBP 3400, SUREBP, BLUETOOTH, MOBILE,UK, Product Code 34BFST-4; c) PROBP 3400, SUREBP, BLUETOOT
    Category
    Medical Device
    Distribution
    2 states
  • HighFDA (Devices)·Z-1510-2024·2024-04-17

    Hillrom Welch Allyn Spot Vision Screener recalled for power cord insulation defect

    Hillrom Welch Allyn Spot Vision Screener VS100 units recalled due to power cord insulation that does not meet electrical safety standards. The affected devices may pose an electrical hazard to users.

    Product
    Hillrom Welch Allyn Spot Vision Screener VS100, marketed under the following models: a) SPOT VISION SCREENER,W/O CASE,PLUG2/EUR, VS100-2; b) SPOT VISION SCREENER,W/O CASE,PLUG4/UK, VS100-4; c) SPOT VISION SCREENER,W/O CASE,PLUG7/SA, VS100-7; d) SPOT VISION SCREENER,W/CAS
    Category
    Medical Device
    Distribution
    2 states
  • ModerateFDA (Devices)·Z-1400-2024·2024-04-10

    Hill-Rom PRO+ Pressure Relief Mattress Service Correction Reassessment

    Baxter Healthcare is reassessing 232 Hill-Rom PRO+ pressure relief mattresses due to identified inconsistencies in service records from a previous correction. These mattresses must be verified to confirm corrections were properly applied.

    Product
    Hill-Rom PRO+ 36" MRS Surface, REF P7924A03, The pro+ mattress is intended for patient support and for the prevention and/or treatment of pressure injuries.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1380-2024·2024-04-03

    Baxter Supple Peri-Guard Repair Patch contraindicated for neurosurgery due to endotoxin

    Baxter is recalling specific lot codes of Supple Peri-Guard Repair Patch because endotoxin levels may exceed limits for cerebrospinal fluid-contacting devices. The product should not be used in neurosurgery.

    Product
    Baxter Supple Peri-Guard Repair Patch (new product codes): a) SPG0404, b) SPG0406, c) SPG0608, d) SPG0814, e) SPG1016
    Category
    Medical Device
    Distribution
    5 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.