Name: FDA Enforcement Actions Against Baxter Healthcare Corporation
Creator: Argus HQ
License: https://argushq.ai/methodology

Baxter Healthcare Corporation carries one of the largest multi-year FDA recall footprints tracked in the Argus HQ database: 208 recalls across 70 distinct FDA report dates from February 2023 through July 2026, 51 of them Class I (the FDA's most-serious rating). Its record spans multiple product lines integrated across recent acquisitions -- Spectrum IQ and Novum IQ infusion pumps, Welch Allyn (Hillrom) vital-signs monitors and Life2000 ventilators, Baxter peritoneal dialysis solutions, and Welch Allyn ECG carts. The tables below compute severity mix, month-by-month velocity, and recurring recall-reason categories directly from those tracked records, each row linked to its FDA.gov source.

FDA action counts (Argus HQ database)

Total tracked FDA actions	208
Recalls	208
Warning letters	0
Form 483 inspection citations	0
Most recent tracked action	July 8, 2026
Most severe rating on file	critical

Recall severity breakdown

Computed from all 208 tracked recalls. FDA classifies each recall Class I (most serious), II, or III on the underlying record; Argus HQ maps that to critical/high/medium/low severity buckets.

high	156 (75.0%)
critical	51 (24.5%)
medium	1 (0.5%)

Recall velocity by month

Months with at least one tracked recall for Baxter Healthcare Corporation, oldest to most recent. Gaps indicate months with zero tracked recalls, not missing data.

Month	Recalls
2023-02	1
2023-03	5
2023-04	2
2023-05	4
2023-07	6
2023-08	1
2023-09	3
2023-10	2
2023-11	2
2023-12	2
2024-01	17
2024-02	3
2024-03	3
2024-04	11
2024-05	3
2024-06	1
2024-07	9
2024-08	4
2024-09	5
2024-10	10
2024-11	20
2024-12	11
2025-01	9
2025-03	2
2025-04	26
2025-05	3
2025-06	3
2025-07	4
2025-08	1
2025-09	5
2025-10	18
2025-12	1
2026-01	1
2026-02	2
2026-03	1
2026-04	1
2026-06	1
2026-07	5

Recurring recall-reason patterns

Argus HQ keyword-matched the free-text “reason for recall” field on each tracked record into categories below. FDA does not publish a structured reason code for device recalls, so this is Argus HQ’s own pattern analysis, not an official FDA classification — records that don’t match a listed keyword fall into “Other.”

Other / not pattern-matched	148 recalls
Software	27 recalls
Packaging	13 recalls
Sterility	10 recalls
Battery	9 recalls
Labeling	4 recalls
Malfunction	1 recall
Microbial / contamination	1 recall

Full recall history (208)

Most recent first. Every row links to its Argus HQ record and FDA.gov source.

Date	Severity	Title
2026-07-08	critical	Baxter Healthcare Corporation — Class I recall: Hillrom VOLARA System P.CIRCUIT KIT (Single Patient Use Circuit), Model/Catalog…
2026-07-08	critical	Baxter Healthcare Corporation — Class I recall: Hillrom VOLARA System P.CIRCUIT 5KIT AC, (Single Patient Use Circuit), Model/Cat…
2026-07-08	high	Baxter Healthcare Corporation — Class II recall: Adapter for Head Positioning, Model/Catalog Number: 1739994, when used in conjun…
2026-07-08	critical	Baxter Healthcare Corporation — Class I recall: Hillrom VOLARA P.CIRCUIT 5KIT (System Single Patient Use Circuit), Model/Catalog…
2026-07-08	critical	Baxter Healthcare Corporation — Class I recall: Hillrom VOLARA System P.CIRCUIT KIT AC (Single Patient Use Circuit), Model/Catal…
2026-06-10	high	Baxter Healthcare Corporation — Class II recall: Brand Name: Exacta Mix Product Name: Vented Micro-Volume Inlet Model/Catalog N…
2026-04-08	critical	Baxter Healthcare Corporation — Class I recall: Blue Ventilator Adapter Module, single-patient use circuit, Product Code M07937.…
2026-03-25	high	Baxter Healthcare Corporation — Class II recall: Brand Name: Welch Allyn, Inc. Product Name: Welch Allyn Spot Vision Screener VS…
2026-02-25	high	Baxter Healthcare Corporation — Class II recall: Brand Name: Spectrum IQ Product Name: Infusion Pump Model/Catalog Number: 3570…
2026-02-04	high	Baxter Healthcare Corporation — Class II recall: Sterile Water for Irrigation, 250 mL, Single-Dose Plastic Bottle, Rx Only, Baxte…
2026-01-28	high	Baxter Healthcare Corporation — Class II recall: SIGMA Spectrum Infusion Pump, Model/Catalog Number: 35700BAX2
2025-12-10	high	Baxter Healthcare Corporation — Class II recall: Welch Allyn INF BAG, Thigh 1-Tube, Model/Catalog Number: REF 5089-18; Product r…
2025-10-29	high	Baxter Healthcare Corporation — Class II recall: Oral Probe (Product code 02893-000), accessory used with Welch Allyn SureTemp Pl…
2025-10-22	high	Baxter Healthcare Corporation — Class II recall: CLEARLINK SYSTEM CONTINU-FLO Solution Set, Non-Vented, three CLEARLINK Luer Acti…
2025-10-22	high	Baxter Healthcare Corporation — Class II recall: CLEARLINK SYSTEM EXTENSION SET, Straight-Type Extension Set, Standard Bore, CLEA…
2025-10-22	high	Baxter Healthcare Corporation — Class II recall: CLEARLINK System Solution Set, DUO-VENT, CLEARLINK Luer Activated Valve, 10 drop…
2025-10-22	high	Baxter Healthcare Corporation — Class II recall: CLEARLINK SYSTEM Solution Set, Non-Vented, two CLEARLINK Luer Activated Valves,…
2025-10-22	high	Baxter Healthcare Corporation — Class II recall: CLEARLINK SYSTEM CONTINU-FLO Solution Set, Non-Vented, three CLEARLINK Luer Acti…
2025-10-22	high	Baxter Healthcare Corporation — Class II recall: CLEARLINK System Paclitaxel Set, Non-Vented with Polyethylene Lined Tubing and C…
2025-10-22	high	Baxter Healthcare Corporation — Class II recall: CLEARLINK SYSTEM EXTENSION SET, Straight-Type Extension Set, Standard Bore, CLE…
2025-10-22	high	Baxter Healthcare Corporation — Class II recall: CLEARLINK SYSTEM CONTINU-FLO Solution Set, Non-Vented, two CLEARLINK Luer Activa…
2025-10-22	high	Baxter Healthcare Corporation — Class II recall: CONTINU-FLO Solution Set, Non-Vented, two CLEARLINK Luer Activated Valves, Backc…
2025-10-22	high	Baxter Healthcare Corporation — Class II recall: CLEARLINK SYSTEM NON-DEHP CONTINU-FLO SOLN SET, 96" (2,4 m), Product Code: 2H85…
2025-10-22	high	Baxter Healthcare Corporation — Class II recall: CLEARLINK SYSTEM CONTINU-FLO Solution Set, Non-Vented, three CLEARLINK Luer Acti…
2025-10-22	high	Baxter Healthcare Corporation — Class II recall: CLEARLINK SYSTEM CONTINU-FLO Solution Set, Non-Vented, 0.2 Micron Filter, two CL…
2025-10-22	high	Baxter Healthcare Corporation — Class II recall: CLEARLINK SYSTEM EXTENSION SET, Straight-Type Extension Set, Standard Bore, CLE…
2025-10-22	high	Baxter Healthcare Corporation — Class II recall: CLEARLINK System Non_DEHP Extenstion Set, Straight-Type Extension Set, Standard…
2025-10-22	high	Baxter Healthcare Corporation — Class II recall: CLEARLINK SYSTEM CONTINU-FLO Solution Set, Non-Vented, two CLEARLINK Luer Activa…
2025-10-22	high	Baxter Healthcare Corporation — Class II recall: CLEARLINK SYSTEM CONTINU-FLO Solution Set, Non-Vented, 0.2 Micron Filter, three…
2025-10-01	high	Baxter Healthcare Corporation — Class II recall: Baster Continu-Flo Solution Set, Non-Vented, 2 Clearlink Luer Activated Valves,…
2025-09-10	critical	Baxter Healthcare Corporation — Class I recall: Novum IQ Syringe Pump, Product Code 40700BAX, infusion pump
2025-09-10	critical	Baxter Healthcare Corporation — Class I recall: Novum IQ Syringe Pump, Product Code 40800BAXUS, infusion pump
2025-09-10	critical	Baxter Healthcare Corporation — Class I recall: Novum IQ LVP (Large Volume Pump), Product Code 40700BAXUS, infusion pump
2025-09-03	high	Baxter Healthcare Corporation — Class II recall: Acetaminophen Injection 1000 mg/100 mL (10 mg/mL), packaged in 100 mL Viaflo con…
2025-09-03	high	Baxter Healthcare Corporation — Class II recall: Spectrum IQ Infusion Pump, Product Code 3570009
2025-08-20	critical	Baxter Healthcare Corporation — Class I recall: Baxter Novum IQ Large Volume Pump, Product Code REF 40700BAXUS
2025-07-23	critical	Baxter Healthcare Corporation — Class I recall: Baxter SIGMA Spectrum Infusion Pump V8, Model Number 35700BAX2
2025-07-23	critical	Baxter Healthcare Corporation — Class I recall: Baxter SIGMA Spectrum Infusion Pump V6, Model Number 35700BAX
2025-07-16	critical	Baxter Healthcare Corporation — Class I recall: Hillrom LikoScale component, Product Code 3156232, used with the following adap…
2025-07-16	critical	Baxter Healthcare Corporation — Class I recall: Hillrom Q-Link 13 component, Product Code 3156509, used with the following Mobil…
2025-06-18	high	Baxter Healthcare Corporation — Class II recall: Baxter Novum IQ Syringe Pump, product code 40800BAXUS,
2025-06-18	high	Baxter Healthcare Corporation — Class II recall: 2.5 V replacement rechargeable batteries for Hillrom WELCH ALLYN PocketScope han…
2025-06-04	high	Baxter Healthcare Corporation — Class II recall: Affinity 4 Birthing Bed, Product Codes P3700E100429, P3700E100432, P3700E100433,…
2025-05-28	critical	Baxter Healthcare Corporation — Class I recall: Baxter Novum IQ LVP INFUSION SYSTEM, REF 40700BAXUS
2025-05-21	critical	Baxter Healthcare Corporation — Class I recall: Welch Allyn Life2000 Ventilation system, Product Codes: 1) BT-20-0002; 2) B…
2025-05-21	critical	Baxter Healthcare Corporation — Class I recall: Welch Allyn Life2000 Compressor, Product Codes: 1) BT-80-0004; 2) BT-80-000…
2025-04-23	high	Baxter Healthcare Corporation — Class II recall: Welch Allyn Connex Integrated Wall System, Product Code/Part Numbers: 1) 84MT…
2025-04-23	high	Baxter Healthcare Corporation — Class II recall: Welch Allyn CONNEX Accessory Power Management Stand:
2025-04-23	high	Baxter Healthcare Corporation — Class II recall: Welch Allyn 2-Piece Reusable Blood Pressure Cuff Kits labeled as: 1. WELCH AL…
2025-04-23	high	Baxter Healthcare Corporation — Class II recall: Welch Allyn CP150 Electrocardiograph:
2025-04-23	high	Baxter Healthcare Corporation — Class II recall: Welch Allyn Welch Allyn Connex Spot Monitor, Product Code/ Part Numbers: 1) 7…
2025-04-23	high	Baxter Healthcare Corporation — Class II recall: Welch Allyn DuraShock Aneroid Gauge Sets with a Reusable Blood Pressure Cuff lab…
2025-04-23	high	Baxter Healthcare Corporation — Class II recall: Welch Allyn Connex Vital Signs Monitor, Product Code/Part Numbers: 1) ) Produ…
2025-04-23	high	Baxter Healthcare Corporation — Class II recall: Welch Allyn Connex Vital Signs Monitor (CVSM):
2025-04-23	high	Baxter Healthcare Corporation — Class II recall: Welch Allyn Spot Vital Signs 4400 Device, Product Code/Part Numbers: 1) 44WT-…
2025-04-23	high	Baxter Healthcare Corporation — Class II recall: Welch Allyn Green Series 777 Wall System, Product Code/Part Numbers: 1) 77791…
2025-04-02	high	Baxter Healthcare Corporation — Class II recall: Baxter NovumIQ Syringe INFUSION SYSTEM , REF 40800BAXUS
2025-04-02	high	Baxter Healthcare Corporation — Class II recall: Baxter Stationary column TruSystem 7500 U, Product Code 1730731
2025-04-02	high	Baxter Healthcare Corporation — Class II recall: Baxter TruSystem 7500 Hybrid (MC), Product Code 1773204
2025-04-02	high	Baxter Healthcare Corporation — Class II recall: Baxter Stationary column TruSystem 7500, Product Code 1717020
2025-04-02	high	Baxter Healthcare Corporation — Class II recall: Baxter Operating table column TS7500 MOBIUS, Product Code 1704695
2025-04-02	high	Baxter Healthcare Corporation — Class II recall: Baxter TruSystem 7500 Hybrid Plus (SC), Product Code 1854088
2025-04-02	high	Baxter Healthcare Corporation — Class II recall: Baxter TruSystem 7500 Hybrid MR IMRIS, Product Code 2067886
2025-04-02	high	Baxter Healthcare Corporation — Class II recall: Baxter Floor mounting column TruSystem 7500, Product Code 1717021
2025-04-02	high	Baxter Healthcare Corporation — Class II recall: Progressa Bed Surfaces, intended to be used to treat or prevent pulmonary or oth…
2025-04-02	high	Baxter Healthcare Corporation — Class II recall: Baxter TruSystem 7500 Hybrid (FC), Product Code 1854085
2025-04-02	high	Baxter Healthcare Corporation — Class II recall: Baxter TruSystem 7500 Hybrid Plus (FC), Product Code 1854087
2025-04-02	high	Baxter Healthcare Corporation — Class II recall: Baxter TruSystem 7500 Hybrid (SC), Product Code 1854086
2025-04-02	high	Baxter Healthcare Corporation — Class II recall: Baxter TruSystem 7500, Product Code 4091000
2025-04-02	high	Baxter Healthcare Corporation — Class II recall: Baxter Mobile column TruSystem 7500, Product Code 1717023
2025-04-02	high	Baxter Healthcare Corporation — Class II recall: Baxter Floor mounting column TS 7500 U, Product Code 1730732
2025-04-02	high	Baxter Healthcare Corporation — Class II recall: Baxter Mobile column TruSystem 7500 U, Product Code 1730720
2025-03-12	critical	Baxter Healthcare Corporation — Class I recall: Baxter Sigma Spectrum Infusion System (V6 Platform), Product Code 35700BAX
2025-03-12	critical	Baxter Healthcare Corporation — Class I recall: Baxter Spectrum IQ Infusion System with Dose IQ Safety Software, Product Code 35…
2025-01-29	high	Baxter Healthcare Corporation — Class II recall: Baxter Clearlink System Solution Set with Duo-Vent Spike, REF 2R8538
2025-01-29	high	Baxter Healthcare Corporation — Class II recall: Baxter Solution Set with Duo-Vent Spike, REF 2R8404
2025-01-29	high	Baxter Healthcare Corporation — Class II recall: Baxter Continu-Flo Solution Set with Duo-Vent Spike, REF UC8519
2025-01-22	critical	Baxter Healthcare Corporation — Class I recall: Welch Allyn, Inc., Life2000 Ventilation System, REF BT-20-0002A
2025-01-22	critical	Baxter Healthcare Corporation — Class I recall: Welch Allyn, Inc., Life2000 Ventilation System, REF BT-20-0002AP
2025-01-22	critical	Baxter Healthcare Corporation — Class I recall: Breathe Technologies, Inc., Life2000 Ventilation System, REF BT-20-0002AP
2025-01-22	critical	Baxter Healthcare Corporation — Class I recall: Welch Allyn, Inc., Life 2000 Ventilation System, REF BT-20-0002
2025-01-08	high	Baxter Healthcare Corporation — Class II recall: Baxter SIGMA Spectrum Infusion Pump with Master Drug Library (Version 8), Produ…
2025-01-08	high	Baxter Healthcare Corporation — Class II recall: Baxter SIGMA Spectrum Infusion Pump with Master Drug Library (Version 6), Produc…
2024-12-04	high	Baxter Healthcare Corporation — Class II recall: Baxter MiniCap Extended Life PD Transfer Set with Twist Clamp, Part Number T5C4…
2024-12-04	high	Baxter Healthcare Corporation — Class II recall: Baxter MiniCap Extended Life PD Transfer Set with Twist Clamp, Part Number 5C44…
2024-12-04	high	Baxter Healthcare Corporation — Class II recall: Baxter MiniCap Extended Life PD Transfer Set with Twist Clamp, Part Number 5C44…
2024-12-04	high	Baxter Healthcare Corporation — Class II recall: Baxter MiniCap Extended Life PD Transfer Set (long) with Titanium Spike, Part N…
2024-12-04	high	Baxter Healthcare Corporation — Class II recall: Baxter MiniCap Extended Life PD Transfer Set with Twist Clamp, Part Number R5C4…
2024-12-04	high	Baxter Healthcare Corporation — Class II recall: Baxter MiniCap Extended Life PD Transfer Set with Twist Clamp, Part Number R5C4…
2024-12-04	high	Baxter Healthcare Corporation — Class II recall: Baxter MiniCap Extended Life PD Transfer Set with Twist Clamp, Part Number R5C4…
2024-12-04	high	Baxter Healthcare Corporation — Class II recall: Baxter MiniCap Extended Life PD Transfer Set (short) with Titanium Spike, Part…
2024-12-04	high	Baxter Healthcare Corporation — Class II recall: Baxter MiniCap Extended Life PD Transfer Set with Twist Clamp, Part Number 5C44…
2024-12-04	high	Baxter Healthcare Corporation — Class II recall: Baxter MiniCap Extended Life PD Transfer Set with Twist Clamp, Part Number 5C44…
2024-12-04	high	Baxter Healthcare Corporation — Class II recall: Baxter MiniCap Extended Life PD Transfer Set with Twist Clamp, Part Number R5C4…
2024-11-27	critical	Baxter Healthcare Corporation — Class I recall: Baxter MiniCap Extended Life PD Transfer Set with Twist Clamp, Part Number R5C4…
2024-11-27	critical	Baxter Healthcare Corporation — Class I recall: Baxter MiniCap Extended Life PD Transfer Set with Twist Clamp, Part Number R5C4…
2024-11-27	critical	Baxter Healthcare Corporation — Class I recall: Baxter MiniCap Extended Life PD Transfer Set with Twist Clamp, Part Number 5C44…
2024-11-27	critical	Baxter Healthcare Corporation — Class I recall: Baxter MiniCap Extended Life PD Transfer Set with Twist Clamp, Part Number R5C4…
2024-11-27	critical	Baxter Healthcare Corporation — Class I recall: Baxter MiniCap Extended Life PD Transfer Set with Twist Clamp, Part Number 5C44…
2024-11-27	critical	Baxter Healthcare Corporation — Class I recall: Baxter MiniCap Extended Life PD Transfer Set with Twist Clamp, Part Number 5C44…
2024-11-27	critical	Baxter Healthcare Corporation — Class I recall: Baxter MiniCap Extended Life PD Transfer Set with Twist Clamp, Part Number R5C4…
2024-11-27	critical	Baxter Healthcare Corporation — Class I recall: Baxter MiniCap Extended Life PD Transfer Set with Twist Clamp, Part Number T5C4…
2024-11-27	critical	Baxter Healthcare Corporation — Class I recall: Baxter MiniCap Extended Life PD Transfer Set with Twist Clamp EX Short, Part Nu…
2024-11-27	critical	Baxter Healthcare Corporation — Class I recall: Baxter MiniCap Extended Life PD Transfer Set with Twist Clamp, Part Number 5C44…
2024-11-20	critical	Baxter Healthcare Corporation — Class I recall: Baxter AK 98 Dialysis Machine, Hemodialysis Delivery System, Product Code 955607…
2024-11-20	high	Baxter Healthcare Corporation — Class II recall: Baxter Spectrum IQ Infusion System with Dose IQ Safety Software, Product Code 35…
2024-11-13	high	Baxter Healthcare Corporation — Class II recall: Hillrom Welch Allyn Diagnostic Cardiology Suite (formerly Connex Cardio); Diagno…
2024-11-13	high	Baxter Healthcare Corporation — Class II recall: Hillrom Welch Allyn XScribe Cardiac Stress Testing System; Programmable Diagnost…
2024-11-13	high	Baxter Healthcare Corporation — Class II recall: Regadenoson Injection, 0.4 mg/5 mL (0.08 mg/mL), 5mL Single-Dose Pre-filled Syri…
2024-11-13	high	Baxter Healthcare Corporation — Class II recall: Hillrom Welch Allyn Q-Stress Cardiac Stress Testing System; cardiac stress test
2024-11-13	high	Baxter Healthcare Corporation — Class II recall: Hillrom Welch Allyn HScribe Holter System; ambulatory monitoring
2024-11-13	high	Baxter Healthcare Corporation — Class II recall: Hillrom Welch Allyn Vision Express Holter Analysis System; Electrocardiograph
2024-11-13	high	Baxter Healthcare Corporation — Class II recall: Hillrom Welch Allyn RScribe 12-Lead Electrocardiograph System; Electrocardiograp…
2024-11-06	high	Baxter Healthcare Corporation — Class II recall: a. Hillrom Centrella Smart+ Medical-Surgical Hospital Bed, Product codes: P790…
2024-10-30	high	Baxter Healthcare Corporation — Class II recall: Baxter Operating Table TruSystem 7000 (dV) V, Product code REF 1841083
2024-10-30	high	Baxter Healthcare Corporation — Class II recall: Baxter Operating Table TruSystem 7000 (MBW), Product code REF 1841048
2024-10-30	critical	Baxter Healthcare Corporation — Class I recall: Welch Allyn Life2000 Ventilation System, REF MS-01-0118, within exterior carton…
2024-10-30	high	Baxter Healthcare Corporation — Class II recall: Baxter Operating Table TruSystem 7000 (MBW) V, Product code REF 1841082
2024-10-30	high	Baxter Healthcare Corporation — Class II recall: Baxter Operating Table TruSystem 7000 U14 (MBW) V, Product code REF 2065386
2024-10-30	high	Baxter Healthcare Corporation — Class II recall: Baxter Operating Table TruSystem 7000 V, Product code REF 1841050
2024-10-30	high	Baxter Healthcare Corporation — Class II recall: Baxter Operating table TruSystem 7000 U (MB), Product codes: a) REF 1604786;…
2024-10-30	high	Baxter Healthcare Corporation — Class II recall: Baxter Operating Table TruSystem 7000, Product code REF 1841046
2024-10-30	high	Baxter Healthcare Corporation — Class II recall: Baxter Operating Table TruSystem 7000 (dV), Product code REF 1841049
2024-10-30	high	Baxter Healthcare Corporation — Class II recall: Baxter Operating Table TruSystem 7000 U14 (MBW), Product code REF 2065385
2024-09-25	critical	Baxter Healthcare Corporation — Class I recall: Baxter EXACTAMIX Inlet, Non-Vented, High Volume Inlet, REF H938173, for use in a…
2024-09-25	critical	Baxter Healthcare Corporation — Class I recall: Baxter EXACTAMIX Inlet, Vented, High Volume Inlet, REF H938174, for use in a pha…
2024-09-25	critical	Baxter Healthcare Corporation — Class I recall: Baxter EXACTAMIX Inlet, Vented, Syringe Inlet, REF H938176, for use in a pharmac…
2024-09-25	critical	Baxter Healthcare Corporation — Class I recall: Baxter EXACTAMIX Inlet, Vented, Micro-Volume Inlet, REF H938175, for use in a ph…
2024-09-11	critical	Baxter Healthcare Corporation — Class I recall: Heparin (Heparin Sodium in 0.9% Sodium Chloride Injection), 2,000 units per 1,00…
2024-08-28	high	Baxter Healthcare Corporation — Class II recall: Spectrum Wireless Battery Modules A/B/G/N, product code 36010, used with either…
2024-08-28	high	Baxter Healthcare Corporation — Class II recall: Baxter Spectrum Wireless Battery Modules A/B/G/N, product code 35223, used with…
2024-08-14	high	Baxter Healthcare Corporation — Class II recall: Baxter PST 500 U, Precision Surgical Table, Part number (product code) 4080300
2024-08-14	high	Baxter Healthcare Corporation — Class II recall: Baxter SIGMA Spectrum Infusion Pump, Product Code: 35700BAX2
2024-07-24	critical	Baxter Healthcare Corporation — Class I recall: Volara System. Blue Ventilator Adapter Module. Intermittent positive pressure b…
2024-07-24	critical	Baxter Healthcare Corporation — Class I recall: Volara System. Single Patient Use (SPU) Circuit 5kit for Volara and Single Patie…
2024-07-17	high	Baxter Healthcare Corporation — Class II recall: iLED 7 surgical lights, Model Numbers: a) 4068110 (Ceiling Single Surgical Li…
2024-07-17	high	Baxter Healthcare Corporation — Class II recall: VidiaPort carrying arm, mount for auxiliary products, model numbers: a) 40281…
2024-07-17	high	Baxter Healthcare Corporation — Class II recall: Trulight 5000/3000 Surgical Light, model numbers: a) 4038210 (Duo Surgical Li…
2024-07-17	high	Baxter Healthcare Corporation — Class II recall: Braun Thermoscan¿ PRO 6000 Ear Thermometer
2024-07-17	high	Baxter Healthcare Corporation — Class II recall: Dianeal Low Calcium (2.5 mEq/L) Peritoneal Dialysis Solution with 2.5% Dextrose,…
2024-07-17	high	Baxter Healthcare Corporation — Class II recall: Welch Allyn CP150 Electrocardiograph with Spirometry Option, Product Code: CP150…
2024-07-03	critical	Baxter Healthcare Corporation — Class I recall: Life2000 Ventilator, Product Code: MS-01-0118, which is contained in the Life200…
2024-06-26	high	Baxter Healthcare Corporation — Class II recall: Centrella Max - The Centrella Smart+ Bed is intended for use in healthcare envir…
2024-05-22	high	Baxter Healthcare Corporation — Class II recall: Spectrum IQ Infusion pump, Product Code 357009
2024-05-15	high	Baxter Healthcare Corporation — Class II recall: Baxter Spectrum IQ Infusion Pump, Product Code 3570009
2024-05-01	high	Baxter Healthcare Corporation — Class II recall: Baxter Seprafilm Adhesion Barrier 1 Half Sheet, 5-PK, REF 664103, for use in abd…
2024-04-24	high	Baxter Healthcare Corporation — Class II recall: Surgical Tools and Cardiovascular Specialty marketing brochures, Reference numbe…
2024-04-24	high	Baxter Healthcare Corporation — Class II recall: Surgical Tools and Cardiovascular Specialty marketing brochures, Reference numbe…
2024-04-24	high	Baxter Healthcare Corporation — Class II recall: Surgical Tools and Cardiovascular Specialty marketing brochures, Reference numbe…
2024-04-17	high	Baxter Healthcare Corporation — Class II recall: Hillrom Welch Allyn Connex ProBP 3400 Digital Blood Pressure Device, marketed un…
2024-04-17	high	Baxter Healthcare Corporation — Class II recall: Power Cords, marketed under the following models: a) CORD,METAL EARTH PIN, 2.…
2024-04-17	high	Baxter Healthcare Corporation — Class II recall: Hillrom Welch Allyn Spot Vision Screener VS100, marketed under the following mod…
2024-04-10	high	Baxter Healthcare Corporation — Class II recall: Hill-Rom PRO+ 36" MRS Surface, REF P7924A03, The pro+ mattress is intended for p…
2024-04-03	high	Baxter Healthcare Corporation — Class II recall: Baxter Supple Peri-Guard Repair Patch (legacy product codes): a) PC0404SNBIO,…
2024-04-03	high	Baxter Healthcare Corporation — Class II recall: Baxter Supple Peri-Guard Repair Patch (new product codes): a) SPG0404, b) S…
2024-04-03	high	Baxter Healthcare Corporation — Class II recall: Baxter Peri-Guard Repair Patch (new product codes): a) PG0404, b) PG0608,…
2024-04-03	high	Baxter Healthcare Corporation — Class II recall: Baxter Peri-Guard Repair Patch (legacy product codes): a) PC0404NBIO, b) PC…
2024-03-27	high	Baxter Healthcare Corporation — Class II recall: HDS Traction Boot II, REF AR-6529-23, The Traction Boot is designed to position,…
2024-03-20	high	Baxter Healthcare Corporation — Class II recall: CLEARLINK Non-DEHP Solution Set Luer Lock Adapter, Product Code 2R8401
2024-03-20	high	Baxter Healthcare Corporation — Class II recall: STERIS Boot Assembly, Traction Device, OT 1000, Part Number REF 10009192
2024-02-28	high	Baxter Healthcare Corporation — Class II recall: Norepinephrine Bitartrate in 5% Dextrose Injection, 8 mg/ 250 mL (32 mcg/mL), Fo…
2024-02-28	critical	Baxter Healthcare Corporation — Class I recall: Baxter Exactamix Pro 2400, REF EXM24DY
2024-02-28	critical	Baxter Healthcare Corporation — Class I recall: Baxter Exactamix Pro 1200, REF EXM12DY
2024-01-17	high	Baxter Healthcare Corporation — Class II recall: XScribe Cardiac Stress Testing System, version 6, with below product names and c…
2024-01-17	high	Baxter Healthcare Corporation — Class II recall: Baxter Ostene Hemostasis Material, Product Codes: a) 1503831, 3.5 G; b) 15038…
2024-01-17	high	Baxter Healthcare Corporation — Class II recall: Baxter Vascular Probe, Product Codes: a) 7081015: 8CM, 1- 1.5 MM GLOBAL,…
2024-01-17	high	Baxter Healthcare Corporation — Class II recall: PERI-GUARD SUPPLE, Product Codes: a) SPG1016: 10X16 CM US, TS; b) SPG0404:…
2024-01-17	high	Baxter Healthcare Corporation — Class II recall: Peri-Guard Repair Patch, Product Codes: a) PC1016NBIO: 10X16CMUS, b) PC1225N…
2024-01-17	high	Baxter Healthcare Corporation — Class II recall: Baxter FloSeal Hemostatic Matrix NL, 5 mL, Product Codes: ADS201883
2024-01-17	high	Baxter Healthcare Corporation — Class II recall: XScribe CP Cardiac Stress Testing System, version 6, with below product names an…
2024-01-17	high	Baxter Healthcare Corporation — Class II recall: Baxter Coseal Premix, Surgical Sealant, Product Codes: a) 934070; b) 934071;…
2024-01-17	high	Baxter Healthcare Corporation — Class II recall: Q-Stress Cardiac Stress Testing System, version 6, with below product name / pro…
2024-01-17	high	Baxter Healthcare Corporation — Class II recall: Baxter Floseal Hemostatic Matrix Fast Prep, Product Codes: a) ADS201844, 5 mL…
2024-01-17	high	Baxter Healthcare Corporation — Class II recall: Baxter Flo-Rester, Disposable internal vessel occluder, distributed in the follo…
2024-01-17	high	Baxter Healthcare Corporation — Class II recall: Baxter Flo-Thru Intraluminal Shunt, Product Codes: a) Product Code FT12100, 1.…
2024-01-17	high	Baxter Healthcare Corporation — Class II recall: Peri-Guard Repair Patch, Product Codes: a) PG1016 : 10 X 16 CMUS, TS b) PG12…
2024-01-17	high	Baxter Healthcare Corporation — Class II recall: Vascu-Guard Peripheral Vascular Patch (GLOBAL), Product Codes: a) VG0108N: 0.…
2024-01-17	high	Baxter Healthcare Corporation — Class II recall: Baxter FloSeal Hemostatic Matrix RECOTHROM, Product Codes: a) ADS202105, 5mL-6…
2024-01-17	high	Baxter Healthcare Corporation — Class II recall: Baxter Preveleak Surgical Sealant, Product Codes: ADS201808
2024-01-17	high	Baxter Healthcare Corporation — Class II recall: Vascu-Guard Peripheral Vascular Patch (US), Product Codes: a) VG0108: 0.8 X 8…
2023-12-20	high	Baxter Healthcare Corporation — Class II recall: Baxter Amia Automated Peritoneal Dialysis (APD) Cycler Set, REF 5C5479
2023-12-13	high	Baxter Healthcare Corporation — Class II recall: Ondansetron Injection, USP, 4 mg/2 mL (2 mg/mL), 2 mL per vial, Rx only, Manufac…
2023-11-15	critical	Baxter Healthcare Corporation — Class I recall: Novum IQ Syringe infusion system, Product Code 40800BAXUS
2023-11-08	high	Baxter Healthcare Corporation — Class II recall: HILLROM PROGRESSA+ BED, Product Codes: P7501A000016, P7501A000019, P7501A000031…
2023-10-25	high	Baxter Healthcare Corporation — Class II recall: Doxil (doxorubicin hydrochloride liposome injection) 50 mg in 25 mL (2 mg/mL), S…
2023-10-04	high	Baxter Healthcare Corporation — Class II recall: Baxter Epiphany Cardio Server E3 ECG Management System Servers with software ver…
2023-09-20	high	Baxter Healthcare Corporation — Class II recall: Welch Allyn Connex Spot Monitor
2023-09-06	high	Baxter Healthcare Corporation — Class II recall: DIANEAL Low Calcium (2.5 mEq/L) Peritoneal Dialysis Solution 1.5% Dextrose, pack…
2023-09-06	high	Baxter Healthcare Corporation — Class II recall: Dianeal PD-2 Peritonial Dialysis Solution with 1.5% Dextrose, 5000 mL AMBU-FLEX…
2023-08-30	medium	Baxter Healthcare Corporation — Class III recall: Bendamustine HCl Injection, 100mg/4mL (25mg/mL), One 4 mL Multiple-Dose Vial, Rx…
2023-07-26	high	Baxter Healthcare Corporation — Class II recall: GEM FLOW COUPLER Monitor, PN 5156-00000-011
2023-07-19	critical	Baxter Healthcare Corporation — Class I recall: The Spectrum IQ Infusion System with Dose IQ Safety Software, Product Code 35700…
2023-07-19	critical	Baxter Healthcare Corporation — Class I recall: SIGMA Spectrum Infusion Pump, Product Code 35700BAX2
2023-07-19	high	Baxter Healthcare Corporation — Class II recall: Allen Advance Chest Support with Pad
2023-07-05	high	Baxter Healthcare Corporation — Class II recall: NaviCare Patient Safety V3.9.200 to 3.9.600, used with the Centrella Bed
2023-07-05	high	Baxter Healthcare Corporation — Class II recall: Voalte Patient Safety, Part Number 4.0, V4.0.000 to 4.0.401, used with the Centr…
2023-05-10	high	Baxter Healthcare Corporation — Class II recall: Hill-Rom pro+ mattress, product codes (REF): a) 20877002S, b) 20877003S, c) 208…
2023-05-03	high	Baxter Healthcare Corporation — Class II recall: GEM NEUROTUBE, Absorbable Woven Polyglycolic Acid Mesh Tube, Product Codes: a)…
2023-05-03	high	Baxter Healthcare Corporation — Class II recall: Dianeal PD-2 Peritonial Dialysis Solution with 1.5% Dextrose, 3000 mL per Ambu-F…
2023-05-03	high	Baxter Healthcare Corporation — Class II recall: Dianeal Low Calcium (2.5 mEq/L) Peritonial Dialysis Solution with 1.5% Dextrose,…
2023-04-26	high	Baxter Healthcare Corporation — Class II recall: ExactaMed Oral Dispenser - 20 mL Clear Pharmacy Pack, REF H9387120; Oral medicat…
2023-04-05	high	Baxter Healthcare Corporation — Class II recall: Automated Peritoneal Dialysis System. Used for automatic control of dialysis so…
2023-03-15	high	Baxter Healthcare Corporation — Class II recall: Baxter MiniCap Disconnect Cap with Povidone-Iodine Solution, 5C4466P; Accessory…
2023-03-08	critical	Baxter Healthcare Corporation — Class I recall: Life2000 Ventilator PKG, Hospital, a) REF BT200011, b) REF BT-20-0011, ventilato…
2023-03-08	critical	Baxter Healthcare Corporation — Class I recall: Life2000 Ventilator , REF MS-01-0118, ventilatory support for the care of indivi…
2023-03-08	critical	Baxter Healthcare Corporation — Class I recall: Life2000 Ventilator PKG, Hospital, a) REF BT20007, b) REF BT-20-0007, ventilator…
2023-03-08	critical	Baxter Healthcare Corporation — Class I recall: Life2000 Ventilator System, a) REF BT-20-0002, b) REF BT-20-0002A, ventilatory s…
2023-02-01	high	Baxter Healthcare Corporation — Class II recall: Baxter Electrocardiograph, ELI 380 -DCS21

Coverage

No independent news coverage was found for Baxter Healthcare Corporation’s FDA recall history at the time this page was published — its enforcement record is small enough that it hasn’t drawn trade-press attention. This page is the most complete public record available.

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Full FDA history for Baxter Healthcare Corporation

Other enforcement deep dives

Compiled by Argus HQ Research from FDA primary sources · Reviewed by Andy Gaber, Founder

Verified from FDA.gov · Last updated: Jul 8, 2026

Cite this record

Reusing this data in reporting or research? Here’s a ready-made citation.

APA

Argus HQ Research (2026). Baxter Healthcare Corporation: FDA Enforcement History. Digital Empire Holdings LLC. Retrieved from https://argushq.ai/enforcement/baxter-healthcare-corporation

MLA

"Baxter Healthcare Corporation: FDA Enforcement History." Argus HQ Research, Digital Empire Holdings LLC, 2026, argushq.ai/enforcement/baxter-healthcare-corporation.

Chicago

Argus HQ Research. "Baxter Healthcare Corporation: FDA Enforcement History." Digital Empire Holdings LLC. Accessed July 24, 2026. https://argushq.ai/enforcement/baxter-healthcare-corporation.

BibTeX

@misc{argushq_argushq_ai_enforcement_baxter_healthcare_corporation_2026,
  title = {Baxter Healthcare Corporation: FDA Enforcement History},
  author = {{Argus HQ Research}},
  year = {2026},
  publisher = {Digital Empire Holdings LLC},
  url = {https://argushq.ai/enforcement/baxter-healthcare-corporation},
  note = {Accessed: July 24, 2026}
}

Source: FDA.gov (aggregated device recalls) ↗