FDA recall record · openFDA
Baxter Healthcare Corporation
202 FDA recalls on record (2023–2026) — 13 drug,189 device. 199 still ongoing.
47
Class I (most serious)
154
Class II
1
Class III
199
ongoing
How to read this. A recall count is not a quality verdict — large manufacturers recall more simply by volume, and a voluntary recall is the safety system working as intended. The signal to weight is the Class I count (the FDA's most-serious tier — reasonable probability of serious harm or death) and whether recalls are still ongoing. Most recalls are Class II/III. "Ongoing" reflects openFDA's last-published status — device recalls often stay marked ongoing long after they're resolved in practice; confirm current status at the FDA.
Most common reasons
IV sets may leak. 16
Cardiovascular Surgery marketing brochure (US-AS46-220001) that was distributed for the products listed below contains i 14
There is a software issue which causes the upper back section to not be operable/adjustable when the "emergency mode" fu 14
There has been an increase in the number of complaints related to the separation of the female connector from the main b 11
Baxter is aware of several recalls by other manufacturers related to the potential risk of exposure to non-dioxin-like 10
Recalls
Blue Ventilator Adapter Module, single-patient use circuit, Product Code M07937. Accessory to Baxter Volara Respiratory Class I 2026-02-18 Baxter Novum IQ Large Volume Pump, Product Code REF 40700BAXUS Class I 2025-07-14 Novum IQ Syringe Pump, Product Code 40800BAXUS, infusion pump Class I 2025-08-04 Baxter SIGMA Spectrum Infusion Pump V6, Model Number 35700BAX Class I 2025-06-20 Novum IQ LVP (Large Volume Pump), Product Code 40700BAXUS, infusion pump Class I 2025-08-04 Welch Allyn Life2000 Compressor, Product Codes: 1) BT-80-0004; 2) BT-80-0004A; 3) BT-80-0008; 4) BT-80-0008A; Class I 2025-04-07 Baxter Novum IQ LVP INFUSION SYSTEM, REF 40700BAXUS Class I 2025-04-24 Baxter SIGMA Spectrum Infusion Pump V8, Model Number 35700BAX2 Class I 2025-06-20 Hillrom LikoScale component, Product Code 3156232, used with the following adapter kits for patient lifts: 1) LikoSc Class I 2025-05-30 Baxter Sigma Spectrum Infusion System (V6 Platform), Product Code 35700BAX Class I 2025-02-05 Baxter Spectrum IQ Infusion System with Dose IQ Safety Software, Product Code 3570009 Class I 2025-02-05 Novum IQ Syringe Pump, Product Code 40700BAX, infusion pump Class I 2025-08-04 Hillrom Q-Link 13 component, Product Code 3156509, used with the following Mobile Patient Lifts: 1) Uno 102 EE Mobile Class I 2025-05-30 Welch Allyn Life2000 Ventilation system, Product Codes: 1) BT-20-0002; 2) BT-20-0002A; 3) BT-20-0002AP; 4) BT20 Class I 2025-04-07 Heparin (Heparin Sodium in 0.9% Sodium Chloride Injection), 2,000 units per 1,000 mL (2 units/mL), 1000 mL Sterile Singl Class I 2024-08-01 Welch Allyn, Inc., Life 2000 Ventilation System, REF BT-20-0002 Class I 2024-12-20 Baxter EXACTAMIX Inlet, Vented, Syringe Inlet, REF H938176, for use in a pharmaceutical compounding device Class I 2024-08-20 Baxter MiniCap Extended Life PD Transfer Set with Twist Clamp, Part Number 5C4482; use in Peritoneal Dialysis Class I 2024-10-21 Baxter MiniCap Extended Life PD Transfer Set with Twist Clamp, Part Number 5C4482S; use in Peritoneal Dialysis Class I 2024-10-21 Volara System. Single Patient Use (SPU) Circuit 5kit for Volara and Single Patient Use (SPU) Circuit kit for Volara. In Class I 2024-05-30 Life2000 Ventilator, Product Code: MS-01-0118, which is contained in the Life2000 Ventilator System, with Product Codes Class I 2024-05-29 Welch Allyn Life2000 Ventilation System, REF MS-01-0118, within exterior carton codes: 1) BT-20-0002, 2) BT-20-0002A, 3 Class I 2024-09-12 Baxter MiniCap Extended Life PD Transfer Set with Twist Clamp, Part Number R5C4482; use in Peritoneal Dialysis Class I 2024-10-21 Breathe Technologies, Inc., Life2000 Ventilation System, REF BT-20-0002AP Class I 2024-12-20 Baxter EXACTAMIX Inlet, Vented, High Volume Inlet, REF H938174, for use in a pharmaceutical compounding device Class I 2024-08-20 Baxter EXACTAMIX Inlet, Vented, Micro-Volume Inlet, REF H938175, for use in a pharmaceutical compounding device Class I 2024-08-20 Baxter MiniCap Extended Life PD Transfer Set with Twist Clamp, Part Number R5C4483; use in Peritoneal Dialysis Class I 2024-10-21 Baxter MiniCap Extended Life PD Transfer Set with Twist Clamp, Part Number R5C4482E; use in Peritoneal Dialysis Class I 2024-10-21 Baxter MiniCap Extended Life PD Transfer Set with Twist Clamp EX Short, Part Number T5C4484; use in Peritoneal Dialysis Class I 2024-10-21 Baxter EXACTAMIX Inlet, Non-Vented, High Volume Inlet, REF H938173, for use in a pharmaceutical compounding device Class I 2024-08-20 Welch Allyn, Inc., Life2000 Ventilation System, REF BT-20-0002AP Class I 2024-12-20 Baxter AK 98 Dialysis Machine, Hemodialysis Delivery System, Product Code 955607. As of February 2025, the firm name is Class I 2024-10-16 Baxter MiniCap Extended Life PD Transfer Set with Twist Clamp, Part Number 5C4483; use in Peritoneal Dialysis Class I 2024-10-21 Baxter MiniCap Extended Life PD Transfer Set with Twist Clamp, Part Number T5C4482; use in Peritoneal Dialysis Class I 2024-10-21 Baxter MiniCap Extended Life PD Transfer Set with Twist Clamp, Part Number 5C4482EJ; use in Peritoneal Dialysis Class I 2024-10-21 Volara System. Blue Ventilator Adapter Module. Intermittent positive pressure breathing device component. Class I 2024-05-30 Baxter MiniCap Extended Life PD Transfer Set with Twist Clamp, Part Number R5C4484; use in Peritoneal Dialysis Class I 2024-10-21 Welch Allyn, Inc., Life2000 Ventilation System, REF BT-20-0002A Class I 2024-12-20 Life2000 Ventilator PKG, Hospital, a) REF BT200011, b) REF BT-20-0011, ventilatory support for the care of individuals Class I 2023-01-25 The Spectrum IQ Infusion System with Dose IQ Safety Software, Product Code 3570009 Class I 2023-06-15 Novum IQ Syringe infusion system, Product Code 40800BAXUS Class I 2023-10-13 Life2000 Ventilator PKG, Hospital, a) REF BT20007, b) REF BT-20-0007, ventilatory support for the care of individuals Class I 2023-01-25 Life2000 Ventilator System, a) REF BT-20-0002, b) REF BT-20-0002A, ventilatory support for the care of individuals Class I 2023-01-25 SIGMA Spectrum Infusion Pump, Product Code 35700BAX2 Class I 2023-06-15 Baxter Exactamix Pro 1200, REF EXM12DY Class I 2023-12-22 Baxter Exactamix Pro 2400, REF EXM24DY Class I 2023-12-22 Life2000 Ventilator , REF MS-01-0118, ventilatory support for the care of individuals Class I 2023-01-25 Brand Name: Spectrum IQ Product Name: Infusion Pump Model/Catalog Number: 3570009 Software Version: N/A Product Desc Class II 2026-01-13 Brand Name: Welch Allyn, Inc. Product Name: Welch Allyn Spot Vision Screener VS100 Model/Catalog Number: VS100 Softwa Class II 2026-02-18 Brand Name: Exacta Mix Product Name: Vented Micro-Volume Inlet Model/Catalog Number: H938175 Product Description: Class II 2026-04-22 Sterile Water for Irrigation, 250 mL, Single-Dose Plastic Bottle, Rx Only, Baxter Healthcare Corporation Deerfield, IL 6 Class II 2025-12-22 Acetaminophen Injection 1000 mg/100 mL (10 mg/mL), packaged in 100 mL Viaflo container, Rx only, Baxter Healthcare Corpo Class II 2025-08-20 CLEARLINK System Solution Set, DUO-VENT, CLEARLINK Luer Activated Valve, 10 drops/mL, 92-inch (2.3 meters), Product code Class II 2025-08-29 Oral Probe (Product code 02893-000), accessory used with Welch Allyn SureTemp Plus 690 (Product codes 01690-200 and 0169 Class II 2025-09-17 Baster Continu-Flo Solution Set, Non-Vented, 2 Clearlink Luer Activated Valves, Backcheck Valve. 10 drops/mL. 112" (2.8 Class II 2025-08-08 Welch Allyn Connex Vital Signs Monitor (CVSM): Class II 2025-03-24 CLEARLINK SYSTEM CONTINU-FLO Solution Set, Non-Vented, three CLEARLINK Luer Activated Valves, Backcheck Valve, Retractab Class II 2025-08-29 Welch Allyn INF BAG, Thigh 1-Tube, Model/Catalog Number: REF 5089-18; Product replacement bladder for the Welch Allyn T Class II 2025-10-28 Welch Allyn Connex Vital Signs Monitor, Product Code/Part Numbers: 1) ) Product Code/Part # 67MXTP-B-ECG3A; 2) ) Pr Class II 2025-03-21 Spectrum IQ Infusion Pump, Product Code 3570009 Class II 2025-07-14 Baxter TruSystem 7500 Hybrid Plus (FC), Product Code 1854087 Class II 2025-02-25 Welch Allyn Welch Allyn Connex Spot Monitor, Product Code/ Part Numbers: 1) 73WT-B; 2) 74CE-B; 3) 74CT-B; 4) 74 Class II 2025-03-21 Welch Allyn CONNEX Accessory Power Management Stand: Class II 2025-03-24 CLEARLINK SYSTEM CONTINU-FLO Solution Set, Non-Vented, 0.2 Micron Filter, two CLEARLINK Luer Activated Valves, Backcheck Class II 2025-08-29 Welch Allyn DuraShock Aneroid Gauge Sets with a Reusable Blood Pressure Cuff labeled as: 1) WELCH ALLYN DURASHOCK Ane Class II 2025-03-21 Baxter Mobile column TruSystem 7500 U, Product Code 1730720 Class II 2025-02-25 CLEARLINK SYSTEM EXTENSION SET, Straight-Type Extension Set, Standard Bore, CLEARLINK Luer Activated Valve, Retractable Class II 2025-08-29 Baxter TruSystem 7500, Product Code 4091000 Class II 2025-02-25 CLEARLINK SYSTEM CONTINU-FLO Solution Set, Non-Vented, three CLEARLINK Luer Activated Valves, Backcheck Valve, Retractab Class II 2025-08-29 Baxter Stationary column TruSystem 7500, Product Code 1717020 Class II 2025-02-25 2.5 V replacement rechargeable batteries for Hillrom WELCH ALLYN PocketScope handles, Product Code 72600 Class II 2025-05-09 Baxter TruSystem 7500 Hybrid (MC), Product Code 1773204 Class II 2025-02-25 Welch Allyn 2-Piece Reusable Blood Pressure Cuff Kits labeled as: 1. WELCH ALLYN 2-Piece Reusable Blood Pressure Cuff Class II 2025-03-21 Baxter TruSystem 7500 Hybrid (SC), Product Code 1854086 Class II 2025-02-25 CLEARLINK SYSTEM CONTINU-FLO Solution Set, Non-Vented, three CLEARLINK Luer Activated Valves, Backcheck Valve, 10 drops/ Class II 2025-08-29 Baxter Novum IQ Syringe Pump, product code 40800BAXUS, Class II 2025-05-12 CLEARLINK SYSTEM NON-DEHP CONTINU-FLO SOLN SET, 96" (2,4 m), Product Code: 2H8519 Class II 2025-08-29 Welch Allyn Spot Vital Signs 4400 Device, Product Code/Part Numbers: 1) 44WT-2; 2) 44WT-3; 3) 44WT-4; 4) 44WT-6 Class II 2025-03-21 Affinity 4 Birthing Bed, Product Codes P3700E100429, P3700E100432, P3700E100433, P3700E100434, P3700E100435, P3700E10043 Class II 2025-05-06 CLEARLINK System Paclitaxel Set, Non-Vented with Polyethylene Lined Tubing and CLEARLINK Luer Activated Valve, 0.2 Micro Class II 2025-08-29 CONTINU-FLO Solution Set, Non-Vented, two CLEARLINK Luer Activated Valves, Backcheck Valve, Plus 4-Way Stopcock Extensio Class II 2025-08-29 CLEARLINK SYSTEM EXTENSION SET, Straight-Type Extension Set, Standard Bore, CLEARLINK Luer Activated Valve, Retractable Class II 2025-08-29 CLEARLINK System Non_DEHP Extenstion Set, Straight-Type Extension Set, Standard Bore, 1.2 Micron Filter, CLEARLINK Luer Class II 2025-08-29 SIGMA Spectrum Infusion Pump, Model/Catalog Number: 35700BAX2 Class II 2025-11-28 Baxter NovumIQ Syringe INFUSION SYSTEM , REF 40800BAXUS Class II 2025-03-03 CLEARLINK SYSTEM CONTINU-FLO Solution Set, Non-Vented, two CLEARLINK Luer Activated Valves, Backcheck Valve, 10 drops/mL Class II 2025-08-29 CLEARLINK SYSTEM CONTINU-FLO Solution Set, Non-Vented, 0.2 Micron Filter, three CLEARLINK Luer Activated Valves, Backche Class II 2025-08-29 Welch Allyn CP150 Electrocardiograph: Class II 2025-03-24 Baxter Stationary column TruSystem 7500 U, Product Code 1730731 Class II 2025-02-25 Welch Allyn Green Series 777 Wall System, Product Code/Part Numbers: 1) 77791-2MP2X; 2) 77791-2MP2XL; 3) 77791-2M Class II 2025-03-21 Baxter TruSystem 7500 Hybrid MR IMRIS, Product Code 2067886 Class II 2025-02-25 Baxter Operating table column TS7500 MOBIUS, Product Code 1704695 Class II 2025-02-25 Welch Allyn Connex Integrated Wall System, Product Code/Part Numbers: 1) 84MTVE2-4; 2) 84MTVE2-6; 3) 84MTVE2-B; Class II 2025-03-21 Progressa Bed Surfaces, intended to be used to treat or prevent pulmonary or other complications associated with immobil Class II 2025-02-25 CLEARLINK SYSTEM CONTINU-FLO Solution Set, Non-Vented, two CLEARLINK Luer Activated Valves. 10 drops/mL, 96-inch (2.4 me Class II 2025-08-29 Baxter TruSystem 7500 Hybrid (FC), Product Code 1854085 Class II 2025-02-25 Baxter TruSystem 7500 Hybrid Plus (SC), Product Code 1854088 Class II 2025-02-25 Baxter Floor mounting column TruSystem 7500, Product Code 1717021 Class II 2025-02-25 CLEARLINK SYSTEM EXTENSION SET, Straight-Type Extension Set, Standard Bore, CLEARLINK Luer Activated Valve, Retractable Class II 2025-08-29 Baxter Floor mounting column TS 7500 U, Product Code 1730732 Class II 2025-02-25 Baxter Mobile column TruSystem 7500, Product Code 1717023 Class II 2025-02-25 CLEARLINK SYSTEM Solution Set, Non-Vented, two CLEARLINK Luer Activated Valves, 10 drops/mL, 100-inch (2.5 meters), Prod Class II 2025-08-29 Dianeal Low Calcium (2.5 mEq/L) Peritoneal Dialysis Solution with 2.5% Dextrose, For Intraperitoneal Administration Only Class II 2024-06-17 Regadenoson Injection, 0.4 mg/5 mL (0.08 mg/mL), 5mL Single-Dose Pre-filled Syringe, Rx only, Manufactured by: Baxter Ph Class II 2024-10-30 Norepinephrine Bitartrate in 5% Dextrose Injection, 8 mg/ 250 mL (32 mcg/mL), For Intravenous Infusion Only, 250 mL vial Class II 2024-01-23 Baxter MiniCap Extended Life PD Transfer Set with Twist Clamp, Part Number 5C4482EJ; use in Peritoneal Dialysis Class II 2024-10-23 Baxter MiniCap Extended Life PD Transfer Set with Twist Clamp, Part Number 5C4482; use in Peritoneal Dialysis Class II 2024-10-23 Baxter Seprafilm Adhesion Barrier 1 Half Sheet, 5-PK, REF 664103, for use in abdominal and pelvic surgery Class II 2024-03-15 Baxter Operating Table TruSystem 7000 (dV) V, Product code REF 1841083 Class II 2024-09-19 Hillrom Welch Allyn Vision Express Holter Analysis System; Electrocardiograph Class II 2024-10-11 Baxter Supple Peri-Guard Repair Patch (legacy product codes): a) PC0404SNBIO, b) PC0608NSBIO, c) PC0814SNBIO, d) Class II 2024-02-28 Hillrom Welch Allyn Q-Stress Cardiac Stress Testing System; cardiac stress test Class II 2024-10-11 Centrella Max - The Centrella Smart+ Bed is intended for use in healthcare environments as a patient support system to p Class II 2024-05-08 Welch Allyn CP150 Electrocardiograph with Spirometry Option, Product Code: CP150A-1ENB. The Electrocardiograph is one of Class II 2024-06-03 Baxter Spectrum IQ Infusion System with Dose IQ Safety Software, Product Code 3570009 Class II 2024-10-02 Baxter Operating Table TruSystem 7000 U14 (MBW), Product code REF 2065385 Class II 2024-09-19 Baxter Continu-Flo Solution Set with Duo-Vent Spike, REF UC8519 Class II 2024-12-20 CLEARLINK Non-DEHP Solution Set Luer Lock Adapter, Product Code 2R8401 Class II 2024-02-08 Braun Thermoscan¿ PRO 6000 Ear Thermometer Class II 2024-06-13 Trulight 5000/3000 Surgical Light, model numbers: a) 4038210 (Duo Surgical Lights}; b) 4038310 (Trio/Quad Surgical Class II 2024-06-04 Surgical Tools and Cardiovascular Specialty marketing brochures, Reference numbers: US-AS18-210002 Surgical Tools Broch Class II 2024-02-22 Surgical Tools and Cardiovascular Specialty marketing brochures, Reference numbers: US-AS18-210002 Surgical Tools Broch Class II 2024-02-22 Hillrom Welch Allyn Diagnostic Cardiology Suite (formerly Connex Cardio); Diagnostic spirometer Class II 2024-10-11 Hill-Rom PRO+ 36" MRS Surface, REF P7924A03, The pro+ mattress is intended for patient support and for the prevention an Class II 2024-03-05 a. Hillrom Centrella Smart+ Medical-Surgical Hospital Bed, Product codes: P7900B000001, P7900B100010, P7900B100024, P7 Class II 2024-09-18 Surgical Tools and Cardiovascular Specialty marketing brochures, Reference numbers: US-AS18-210002 Surgical Tools Broch Class II 2024-02-22 Baxter Peri-Guard Repair Patch (new product codes): a) PG0404, b) PG0608, c) PG0814, d) PG1016, e) PG1225 Class II 2024-02-28 Baxter SIGMA Spectrum Infusion Pump, Product Code: 35700BAX2 Class II 2024-06-14 Baxter Operating Table TruSystem 7000 (MBW) V, Product code REF 1841082 Class II 2024-09-19 Hillrom Welch Allyn Connex ProBP 3400 Digital Blood Pressure Device, marketed under the following models: a) PROBP 34 Class II 2024-03-26 Baxter MiniCap Extended Life PD Transfer Set (short) with Titanium Spike, Part Number T5C4326K; use in Peritoneal Dialy Class II 2024-10-23 HDS Traction Boot II, REF AR-6529-23, The Traction Boot is designed to position, support and/or distract the patient's f Class II 2024-03-11 Baxter Operating Table TruSystem 7000 V, Product code REF 1841050 Class II 2024-09-19 Baxter Peri-Guard Repair Patch (legacy product codes): a) PC0404NBIO, b) PC0608NBIO, c) PC0814NBIO, d) PC1016NBI Class II 2024-02-28 Baxter SIGMA Spectrum Infusion Pump with Master Drug Library (Version 8), Product Code 35700BAX2 Class II 2024-11-19 Spectrum Wireless Battery Modules A/B/G/N, product code 36010, used with either of the following 35700BAX2 (Spectrum V8 Class II 2024-07-17 Baxter Operating Table TruSystem 7000, Product code REF 1841046 Class II 2024-09-19 iLED 7 surgical lights, Model Numbers: a) 4068110 (Ceiling Single Surgical Light); b) 4068120 (Mobile Surgical Ligh Class II 2024-06-04 Baxter MiniCap Extended Life PD Transfer Set with Twist Clamp, Part Number 5C4483; use in Peritoneal Dialysis Class II 2024-10-23 VidiaPort carrying arm, mount for auxiliary products, model numbers: a) 4028110 (Ceiling Single Surgical Light); b) Class II 2024-06-04 Baxter Supple Peri-Guard Repair Patch (new product codes): a) SPG0404, b) SPG0406, c) SPG0608, d) SPG0814, e) Class II 2024-02-28 Baxter Spectrum Wireless Battery Modules A/B/G/N, product code 35223, used with either of the following: 35700BAX2 (Spe Class II 2024-07-17 Baxter PST 500 U, Precision Surgical Table, Part number (product code) 4080300 Class II 2024-06-28 Baxter Operating Table TruSystem 7000 (dV), Product code REF 1841049 Class II 2024-09-19 Baxter Solution Set with Duo-Vent Spike, REF 2R8404 Class II 2024-12-20 Baxter SIGMA Spectrum Infusion Pump with Master Drug Library (Version 6), Product Code 35700BAX Class II 2024-11-19 Baxter MiniCap Extended Life PD Transfer Set (long) with Titanium Spike, Part Number T5C4325K; use in Peritoneal Dialys Class II 2024-10-23 Baxter MiniCap Extended Life PD Transfer Set with Twist Clamp, Part Number R5C4482E; use in Peritoneal Dialysis Class II 2024-10-23 Baxter Clearlink System Solution Set with Duo-Vent Spike, REF 2R8538 Class II 2024-12-20 Baxter Operating table TruSystem 7000 U (MB), Product codes: a) REF 1604786; b) REF 1604788; c) REF 1723633 Class II 2024-09-19 Hillrom Welch Allyn RScribe 12-Lead Electrocardiograph System; Electrocardiograph Class II 2024-10-11 Baxter MiniCap Extended Life PD Transfer Set with Twist Clamp, Part Number 5C4482S; use in Peritoneal Dialysis Class II 2024-10-23 Baxter Operating Table TruSystem 7000 (MBW), Product code REF 1841048 Class II 2024-09-19 Spectrum IQ Infusion pump, Product Code 357009 Class II 2024-04-09 Baxter MiniCap Extended Life PD Transfer Set with Twist Clamp, Part Number R5C4483; use in Peritoneal Dialysis Class II 2024-10-23 Hillrom Welch Allyn HScribe Holter System; ambulatory monitoring Class II 2024-10-11 Power Cords, marketed under the following models: a) CORD,METAL EARTH PIN, 2.5A,250V,2.5M,C7, 714682; b) PLFM CLASS Class II 2024-03-26 Baxter MiniCap Extended Life PD Transfer Set with Twist Clamp, Part Number R5C4482; use in Peritoneal Dialysis Class II 2024-10-23 Baxter Spectrum IQ Infusion Pump, Product Code 3570009 Class II 2024-03-20 Hillrom Welch Allyn XScribe Cardiac Stress Testing System; Programmable Diagnostic Computer Class II 2024-10-11 Baxter MiniCap Extended Life PD Transfer Set with Twist Clamp, Part Number R5C4484; use in Peritoneal Dialysis Class II 2024-10-23 STERIS Boot Assembly, Traction Device, OT 1000, Part Number REF 10009192 Class II 2024-02-14 Baxter MiniCap Extended Life PD Transfer Set with Twist Clamp, Part Number T5C4482; use in Peritoneal Dialysis Class II 2024-10-23 Hillrom Welch Allyn Spot Vision Screener VS100, marketed under the following models: a) SPOT VISION SCREENER,W/O CASE Class II 2024-03-26 Baxter Operating Table TruSystem 7000 U14 (MBW) V, Product code REF 2065386 Class II 2024-09-19 Dianeal PD-2 Peritonial Dialysis Solution with 1.5% Dextrose, 5000 mL AMBU-FLEX ll Container with yellow pull ring, Rx O Class II 2023-08-11 Doxil (doxorubicin hydrochloride liposome injection) 50 mg in 25 mL (2 mg/mL), Single-Dose Vial, Rx only, Manufactured f Class II 2023-08-24 DIANEAL Low Calcium (2.5 mEq/L) Peritoneal Dialysis Solution 1.5% Dextrose, packaged in a) 2000 mL AMBU-FLEX II Containe Class II 2023-08-11 Dianeal PD-2 Peritonial Dialysis Solution with 1.5% Dextrose, 3000 mL per Ambu-Flex II Container bag, Rx Only, Baxter He Class II 2023-03-15 Dianeal Low Calcium (2.5 mEq/L) Peritonial Dialysis Solution with 1.5% Dextrose, packaged in a) 5000 mL per Ambu-Flex II Class II 2023-03-15 Ondansetron Injection, USP, 4 mg/2 mL (2 mg/mL), 2 mL per vial, Rx only, Manufactured for: Baxter Healthcare Corporation Class II 2023-11-14 Baxter Flo-Thru Intraluminal Shunt, Product Codes: a) Product Code FT12100, 1.00 GLOBAL; b) Product Code FT12125, 1. Class II 2023-12-06 Baxter Floseal Hemostatic Matrix Fast Prep, Product Codes: a) ADS201844, 5 mL b) ADS201845, 10mL Class II 2023-12-06 Automated Peritoneal Dialysis System. Used for automatic control of dialysis solution exchanges. Class II 2023-02-22 Vascu-Guard Peripheral Vascular Patch (US), Product Codes: a) VG0108: 0.8 X 8 CM US, TS; b) VG0110: 1 X 10 CM US, T Class II 2023-12-06 XScribe CP Cardiac Stress Testing System, version 6, with below product names and codes: a) X-SCRIBE CPI KIT WIRELESS US Class II 2023-12-08 Baxter FloSeal Hemostatic Matrix NL, 5 mL, Product Codes: ADS201883 Class II 2023-12-06 Baxter Epiphany Cardio Server E3 ECG Management System Servers with software versions: a) v6.1.x, b) v6.2.x, c) v7.0.x. Class II 2023-08-10 Baxter Flo-Rester, Disposable internal vessel occluder, distributed in the following sizes: a) Product Code 50100: 12M Class II 2023-12-06 PERI-GUARD SUPPLE, Product Codes: a) SPG1016: 10X16 CM US, TS; b) SPG0404: 4 X 4 CM US, TS; c) SPG0608: 6 X 8 Class II 2023-12-06 NaviCare Patient Safety V3.9.200 to 3.9.600, used with the Centrella Bed Class II 2023-05-19 Voalte Patient Safety, Part Number 4.0, V4.0.000 to 4.0.401, used with the Centrella Bed Class II 2023-05-19 GEM FLOW COUPLER Monitor, PN 5156-00000-011 Class II 2023-06-19 Baxter Amia Automated Peritoneal Dialysis (APD) Cycler Set, REF 5C5479 Class II 2023-11-15 Welch Allyn Connex Spot Monitor Class II 2023-08-10 Allen Advance Chest Support with Pad Class II 2023-05-18 Hill-Rom pro+ mattress, product codes (REF): a) 20877002S, b) 20877003S, c) 20877004S, d) 20877007S, e) 20877008S, f) 2 Class II 2023-03-31 HILLROM PROGRESSA+ BED, Product Codes: P7501A000016, P7501A000019, P7501A000031, P7501A000032, P7501A000033, P7501A0000 Class II 2023-10-04 Baxter MiniCap Disconnect Cap with Povidone-Iodine Solution, 5C4466P; Accessory to disposable administration set for per Class II 2023-02-01 Baxter Coseal Premix, Surgical Sealant, Product Codes: a) 934070; b) 934071; c) 934072 Class II 2023-12-06 Vascu-Guard Peripheral Vascular Patch (GLOBAL), Product Codes: a) VG0108N: 0.8X8 CM GLOBAL, b) VG0110N: 1X10 CM G Class II 2023-12-06 Baxter Preveleak Surgical Sealant, Product Codes: ADS201808 Class II 2023-12-06 ExactaMed Oral Dispenser - 20 mL Clear Pharmacy Pack, REF H9387120; Oral medication syringe Class II 2023-03-20 Baxter Ostene Hemostasis Material, Product Codes: a) 1503831, 3.5 G; b) 1503832, 2.5 G; c) 1503833, 1.0 G Class II 2023-12-06 Baxter Vascular Probe, Product Codes: a) 7081015: 8CM, 1- 1.5 MM GLOBAL, b) 7081520: 8CM, 1.5-2 MM GLOBAL, c) Class II 2023-12-06 GEM NEUROTUBE, Absorbable Woven Polyglycolic Acid Mesh Tube, Product Codes: a) 5311-01240-010, b) 5311-01240-012; for Class II 2023-03-27 Peri-Guard Repair Patch, Product Codes: a) PG1016 : 10 X 16 CMUS, TS b) PG1225: 12 X 25 CMUS, TS c) PG0404: 4 X 4 Class II 2023-12-06 Baxter FloSeal Hemostatic Matrix RECOTHROM, Product Codes: a) ADS202105, 5mL-6 PK US b) ADS202110, 10mL US Class II 2023-12-06 Q-Stress Cardiac Stress Testing System, version 6, with below product name / product codes: a) QS6 AM12Q KIT AHA XML / Q Class II 2023-12-08 XScribe Cardiac Stress Testing System, version 6, with below product names and codes: a) XS6/RS6 REVIEW WKSTN KIT, XR-6A Class II 2023-12-08 Peri-Guard Repair Patch, Product Codes: a) PC1016NBIO: 10X16CMUS, b) PC1225NBIO: 12X25CMUS, c) PC0404NBIO: 4X4CM Class II 2023-12-06 Bendamustine HCl Injection, 100mg/4mL (25mg/mL), One 4 mL Multiple-Dose Vial, Rx only, Manufactured for Baxter Healthcar Class III 2023-08-14
RECORDED — these are the FDA's published recall enforcement records (openFDA). Recalls are listed under the exact firm name as filed; a large manufacturer may also file under name variants, so this may not be the company's complete cross-variant record — confirm at the FDA recall database. This page informs and routes; it is not medical advice or a verdict on the company.