Recall Register

Baxter Healthcare Corporation: FDA recalls

FDA enforcement reports name Baxter Healthcare Corporation as the recalling firm in 193 events. The events have 434 product records. The recalls started from 2011 to 2026.

See the 193 events

It is important to note that most of the time recall classifications are determined after the recalling firm provides all of the information needed to determine the risk posed to public health. The classification and posting in the FDA Enforcement Report should not be seen as an expansion or change to a firm’s voluntary public warning.

FDA publishes these words. Source: FDA, Enforcement Reports, Important Note, read on . openFDA export of .

Enforcement events

193 events, newest first.

FDA enforcement events of Baxter Healthcare Corporation
InitiatedProduct (first record)TypeClassRecordsStatus
17 Aug 20260.9% Sodium Chloride Injection USP 500 mL, VIAFLEX Plastic Containers, with 24 units per case. Baxter Healthcare Corporation, Deerfield, IL, 60015, USA, Made in USA, NDC 0338-0049-03DrugClass I1Ongoing
17 Aug 2026Dextrose Injection, USP, 70 %, 2000 mL bags, Rx Only, Baxter Healthcare Corporation Deerfield, IL, 60016, Made in USA, NDC 00338-0719-06DrugClass I1Ongoing
11 Aug 2026Baxter Novum IQ Syringe Pump, Model Number 40800BAXUSDeviceClass II2Ongoing
6 Aug 2026Vancomycin Injection, USP in 5% Dextrose, 1 g per 200mL (5 mg/mL), in GALAXY Single-Dose Container, Rx only, Sterile Nonpyrogenic, Iso-osmotic, Baxter Healthcare Corporation, Deerfield, IL, 60015 USA, NDC 0338-3552-48.DrugClass II17Ongoing
24 Jul 2026Cefazolin in Dextrose, Injection, USP, 2g / 100mL (20mg / mL) Single-Dose Infusion Bag in 100mL GALAXY Plastic Container, Frozen Premix, Sterile, Rx only, Manufactured by Baxter Healthcare Corporation, Deerfield, IL 60015, USA, NDC 0338-3508-41.DrugClass I1Ongoing
30 Jun 2026Baxter Duo-Vent Solution Set and Male Luer Lock Adapter, Product Code 1C8507; Solution Administration SetsDeviceClass I1Ongoing
21 May 2026Hillrom VOLARA System P.CIRCUIT KIT (Single Patient Use Circuit), Model/Catalog Number REF M08085; Oscillation Lung Expansion Therapy, positive pressure breathing deviceDeviceClass I4Ongoing
22 Apr 2026Brand Name: Exacta Mix Product Name: Vented Micro-Volume Inlet Model/Catalog Number: H938175 Product Description: Tubing sets with push-on connector on one end (to attach to the Fluid Selector Valve) and a spike or other appropriate connector on the opposite end to attach the source container.DeviceClass II1Ongoing
21 Apr 2026Adapter for Head Positioning, Model/Catalog Number: 1739994, when used in conjunction with the side rails of the Upper Back Section H V U component (product code 1909813) on Baxter operating tablesDeviceClass II1Ongoing
18 Feb 2026Brand Name: Welch Allyn, Inc. Product Name: Welch Allyn Spot Vision Screener VS100 Model/Catalog Number: VS100 Software Version: Software version 3.2.0.1 Product Description: Welch Allyn Spot Vision Screener VS100, FDA product code name: Refractometer, ophthalmic One unit per packageDeviceClass II1Ongoing
18 Feb 2026Blue Ventilator Adapter Module, single-patient use circuit, Product Code M07937. Accessory to Baxter Volara Respiratory Therapy system.DeviceClass I1Ongoing
13 Jan 2026Brand Name: Spectrum IQ Product Name: Infusion Pump Model/Catalog Number: 3570009 Software Version: N/A Product Description: Infusion Pump, one unit per carton Component: N/ADeviceClass II1Ongoing
22 Dec 2025Sterile Water for Irrigation, 250 mL, Single-Dose Plastic Bottle, Rx Only, Baxter Healthcare Corporation Deerfield, IL 60015 NDC: 0338-0004-02.DrugClass II1Ongoing
28 Nov 2025SIGMA Spectrum Infusion Pump, Model/Catalog Number: 35700BAX2DeviceClass II1Ongoing
28 Oct 2025Welch Allyn INF BAG, Thigh 1-Tube, Model/Catalog Number: REF 5089-18; Product replacement bladder for the Welch Allyn Two-Piece Blood Pressure Cuff.DeviceClass II1Ongoing
17 Sep 2025Oral Probe (Product code 02893-000), accessory used with Welch Allyn SureTemp Plus 690 (Product codes 01690-200 and 01690-400) Thermometers and Welch Allyn SureTemp Plus 692 (01692-200) thermometersDeviceClass II1Ongoing
29 Aug 2025CONTINU-FLO Solution Set, Non-Vented, two CLEARLINK Luer Activated Valves, Backcheck Valve, Plus 4-Way Stopcock Extension Set with two CLEARLINK Luer Activated Valve, Pfoduct code 2C6255DeviceClass II16Ongoing
20 Aug 2025Acetaminophen Injection 1000 mg/100 mL (10 mg/mL), packaged in 100 mL Viaflo container, Rx only, Baxter Healthcare Corporation, Deerfield, IL 60015, Made in Ireland, NDC 36000-306-60.DrugClass II1Ongoing
8 Aug 2025Baster Continu-Flo Solution Set, Non-Vented, 2 Clearlink Luer Activated Valves, Backcheck Valve. 10 drops/mL. 112" (2.8 m), Product Code REF 2C8519; intravascular administration setDeviceClass II1Ongoing
4 Aug 2025Novum IQ LVP (Large Volume Pump), Product Code 40700BAXUS, infusion pumpDeviceClass I3Ongoing
14 Jul 2025Baxter Novum IQ Large Volume Pump, Product Code REF 40700BAXUSDeviceClass I1Ongoing
14 Jul 2025Spectrum IQ Infusion Pump, Product Code 3570009DeviceClass II1Ongoing
20 Jun 2025Baxter SIGMA Spectrum Infusion Pump V6, Model Number 35700BAXDeviceClass I2Ongoing
30 May 2025Hillrom Q-Link 13 component, Product Code 3156509, used with the following Mobile Patient Lifts: 1) Uno 102 EE Mobile lift - Product Code 2010004; 2) Viking L Mobile lift - Product Code 2040044; 3) Viking XL Mobile lift - Product Code 2040043; 4) Viking M Mobile lift - Product Code 2040045A; 5) Viking S Mobile Lift -…DeviceClass I2Ongoing
12 May 2025Baxter Novum IQ Syringe Pump, product code 40800BAXUS,DeviceClass II1Ongoing
9 May 20252.5 V replacement rechargeable batteries for Hillrom WELCH ALLYN PocketScope handles, Product Code 72600DeviceClass II1Ongoing
6 May 2025Affinity 4 Birthing Bed, Product Codes P3700E100429, P3700E100432, P3700E100433, P3700E100434, P3700E100435, P3700E100436, P3700E100437, P3700E100438, P3700E100439, P3700E100441, P3700E100442, P3700E100443, P3700E100444, P3700E100445, P3700E100446, P3700E100448, P3700E100449, P3700E100450, P3700E100453, P3700E100455,…DeviceClass II1Ongoing
24 Apr 2025Baxter Novum IQ LVP INFUSION SYSTEM, REF 40700BAXUSDeviceClass I1Ongoing
7 Apr 2025Welch Allyn Life2000 Ventilation system, Product Codes: 1) BT-20-0002; 2) BT-20-0002A; 3) BT-20-0002AP; 4) BT200007; 5) BT-20-0007; 6) BT200011; 7) BT-20-0011; 8) RMS010118CP.DeviceClass I2Ongoing
24 Mar 2025Welch Allyn Connex Vital Signs Monitor (CVSM):DeviceClass II3Ongoing
21 Mar 2025Welch Allyn Connex Integrated Wall System, Product Code/Part Numbers: 1) 84MTVE2-4; 2) 84MTVE2-6; 3) 84MTVE2-B; 4) 84MTVE2-US; 5) 84MTVEC-6; 6) 84MTVEC-B; 7) 84MTVEP-B; 8) 84MTVEX-4; 9) 84MTVX2-4; 10) 84MTVX2-6; 11) 84MTVX2-B; 12) 84MTVX2-US; 13) 84MTVXC-4; 14) 84MTVXC-B; 15) 84MTVXP-2; 16) 84MTVXP-4; 17) 84MTVXP-B;…DeviceClass II7Ongoing
3 Mar 2025Baxter NovumIQ Syringe INFUSION SYSTEM , REF 40800BAXUSDeviceClass II1Ongoing
25 Feb 2025Baxter Operating table column TS7500 MOBIUS, Product Code 1704695DeviceClass II14Ongoing
25 Feb 2025Progressa Bed Surfaces, intended to be used to treat or prevent pulmonary or other complications associated with immobility, Product Codes P7520A19, P7520A20S, P7520A21, P7520A22S, P7520A23, P7520A24S, P7520A3, P7520A31, P7520A37, P7520A39, P7520A45, and P7520A4S.DeviceClass II1Ongoing
5 Feb 2025Baxter Sigma Spectrum Infusion System (V6 Platform), Product Code 35700BAXDeviceClass I2Ongoing
20 Dec 2024Baxter Solution Set with Duo-Vent Spike, REF 2R8404DeviceClass II3Ongoing
20 Dec 2024Welch Allyn, Inc., Life 2000 Ventilation System, REF BT-20-0002DeviceClass I4Ongoing
19 Nov 2024Baxter SIGMA Spectrum Infusion Pump with Master Drug Library (Version 6), Product Code 35700BAXDeviceClass II2Ongoing
30 Oct 2024Regadenoson Injection, 0.4 mg/5 mL (0.08 mg/mL), 5mL Single-Dose Pre-filled Syringe, Rx only, Manufactured by: Baxter Pharmaceutical Solutions, LLC, Bloomington, IN 47403; Manufactured for: Baxter Healthcare Corporation, Deerfield, IL 60015. NDC: 36000-364-01DrugClass II1Ongoing
23 Oct 2024Baxter MiniCap Extended Life PD Transfer Set with Twist Clamp, Part Number 5C4482; use in Peritoneal DialysisDeviceClass II11Ongoing
21 Oct 2024Baxter MiniCap Extended Life PD Transfer Set with Twist Clamp, Part Number 5C4482; use in Peritoneal DialysisDeviceClass I10Ongoing
16 Oct 2024Baxter AK 98 Dialysis Machine, Hemodialysis Delivery System, Product Code 955607. As of February 2025, the firm name is Vantive.DeviceClass I1Ongoing
11 Oct 2024Hillrom Welch Allyn HScribe Holter System; ambulatory monitoringDeviceClass II6Ongoing
2 Oct 2024Baxter Spectrum IQ Infusion System with Dose IQ Safety Software, Product Code 3570009DeviceClass II1Ongoing
19 Sep 2024Baxter Operating table TruSystem 7000 U (MB), Product codes: a) REF 1604786; b) REF 1604788; c) REF 1723633DeviceClass II9Ongoing
18 Sep 2024a. Hillrom Centrella Smart+ Medical-Surgical Hospital Bed, Product codes: P7900B000001, P7900B100010, P7900B100024, P7900B100208, P7900B100273, P7900B100304, P7900B000005, P7900B100011, P7900B100025, P7900B100212, P7900B100277, P7900B100307, P7900B000010, P7900B100017, P7900B100026, P7900B100222, P7900B100281,…DeviceClass II1Ongoing
12 Sep 2024Welch Allyn Life2000 Ventilation System, REF MS-01-0118, within exterior carton codes: 1) BT-20-0002, 2) BT-20-0002A, 3) BT-20-0002AP, 4) BT-20-0007, 5) BT-20-0011, and 6) RMS010118CPDeviceClass I1Ongoing
20 Aug 2024Baxter EXACTAMIX Inlet, Non-Vented, High Volume Inlet, REF H938173, for use in a pharmaceutical compounding deviceDeviceClass I4Ongoing
1 Aug 2024Heparin (Heparin Sodium in 0.9% Sodium Chloride Injection), 2,000 units per 1,000 mL (2 units/mL), 1000 mL Sterile Single Dose Container, Rx Only, Baxter USA, NDC 0338-0433-04DrugClass I1Ongoing
17 Jul 2024Baxter 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 PumpDeviceClass II2Ongoing
28 Jun 2024Baxter PST 500 U, Precision Surgical Table, Part number (product code) 4080300DeviceClass II1Ongoing
17 Jun 2024Dianeal Low Calcium (2.5 mEq/L) Peritoneal Dialysis Solution with 2.5% Dextrose, For Intraperitoneal Administration Only, 6000 mL per bag, Rx Only, Baxter Healthcare Corporation, Deerfield, IL 60015 USA. NDC: 0941-0457-01DrugClass II1Ongoing
14 Jun 2024Baxter SIGMA Spectrum Infusion Pump, Product Code: 35700BAX2DeviceClass II1Ongoing
13 Jun 2024Braun Thermoscan PRO 6000 Ear ThermometerDeviceClass II1Ongoing
4 Jun 2024VidiaPort 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)DeviceClass II3Ongoing
3 Jun 2024Welch 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.DeviceClass II1Ongoing
30 May 2024Volara System. Single Patient Use (SPU) Circuit 5kit for Volara and Single Patient Use (SPU) Circuit kit for Volara. Intermittent positive pressure breathing device.DeviceClass I2Ongoing
29 May 2024Life2000 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.DeviceClass I1Ongoing
8 May 2024Centrella 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) Centrella Max Surface, REF P7922A02; (3)…DeviceClass II1Ongoing
9 Apr 2024Spectrum IQ Infusion pump, Product Code 357009DeviceClass II1Ongoing
26 Mar 2024Hillrom 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, BLUETOOTH, MOBILE,AU, Product Code 34BFST-6; d) PROBP…DeviceClass II3Ongoing
20 Mar 2024Baxter Spectrum IQ Infusion Pump, Product Code 3570009DeviceClass II1Ongoing
15 Mar 2024Baxter Seprafilm Adhesion Barrier 1 Half Sheet, 5-PK, REF 664103, for use in abdominal and pelvic surgeryDeviceClass II1Ongoing
11 Mar 2024HDS Traction Boot II, REF AR-6529-23, The Traction Boot is designed to position, support and/or distract the patient's foot for hip surgeryDeviceClass II1Ongoing
5 Mar 2024Hill-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.DeviceClass II1Ongoing
28 Feb 2024Baxter Peri-Guard Repair Patch (legacy product codes): a) PC0404NBIO, b) PC0608NBIO, c) PC0814NBIO, d) PC1016NBIODeviceClass II4Ongoing
22 Feb 2024Surgical 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 Occluder, Item Numbers: a) 50100, b) 50125,…DeviceClass II3Ongoing
14 Feb 2024STERIS Boot Assembly, Traction Device, OT 1000, Part Number REF 10009192DeviceClass II1Ongoing
8 Feb 2024CLEARLINK Non-DEHP Solution Set Luer Lock Adapter, Product Code 2R8401DeviceClass II1Ongoing
23 Jan 2024Norepinephrine Bitartrate in 5% Dextrose Injection, 8 mg/ 250 mL (32 mcg/mL), For Intravenous Infusion Only, 250 mL vial, Rx Only, Baxter Healthcare Corporation, Deerfield, IL 60015. Made in Ireland. NDC: 0338-0108-20DrugClass II1Ongoing
22 Dec 2023Baxter Exactamix Pro 1200, REF EXM12DYDeviceClass I2Ongoing
8 Dec 2023Q-Stress Cardiac Stress Testing System, version 6, with below product name / product codes: a) QS6 AM12Q KIT AHA XML / QS6-BXXCS: b) QS6 AM12Q KIT BCRT IEC / QS-6CC-DGCXX: c) QS6 AM12Q KIT Z200 BCRT IEC / QS-6CC-DFCXX: d) QS6 AM12Q RS SYS AHA XML / QS-6JB-AXAXA: e) QS6 AM12Q SYS Z200 PCRT AHA XML / QS6-BLXCX: f) QS6…DeviceClass II3Ongoing
6 Dec 2023Baxter Flo-Rester, Disposable internal vessel occluder, distributed in the following sizes: a) Product Code 50100: 12MM, 1.00 MM GLOBAL; b) Product Code 50150: 12MM, 1.50 MM GLOBAL; c) Product Code 50175: 12MM, 1.75 MM GLOBAL; d) Product Code 50200: 12MM, 2.00 MM GLOBAL; e) Product Code 50225: 12MM, 2.25 MM GLOBAL;…DeviceClass II14Ongoing
15 Nov 2023Baxter Amia Automated Peritoneal Dialysis (APD) Cycler Set, REF 5C5479DeviceClass II1Ongoing
14 Nov 2023Ondansetron Injection, USP, 4 mg/2 mL (2 mg/mL), 2 mL per vial, Rx only, Manufactured for: Baxter Healthcare Corporation, Deerfield, IL 60015 USA. Manufactured by: Baxter Pharmaceuticals India Private Ltd, Ahmedabad 382213, India. NDC 36000-012-25DrugClass II1Completed
13 Oct 2023Novum IQ Syringe infusion system, Product Code 40800BAXUSDeviceClass I1Ongoing
4 Oct 2023HILLROM PROGRESSA+ BED, Product Codes: P7501A000016, P7501A000019, P7501A000031, P7501A000032, P7501A000033, P7501A000052, P7501A000053, P7501A000054, P7501A000055, P7501A001851, P7501A001972, P7501A001973, and P7501A001974DeviceClass II1Ongoing
24 Aug 2023Doxil (doxorubicin hydrochloride liposome injection) 50 mg in 25 mL (2 mg/mL), Single-Dose Vial, Rx only, Manufactured for: Baxter Healthcare Corporation, Deerfield, IL 60015. NDC 0338-0067-01DrugClass II1Terminated
14 Aug 2023Bendamustine HCl Injection, 100mg/4mL (25mg/mL), One 4 mL Multiple-Dose Vial, Rx only, Manufactured for Baxter Healthcare Corporation, Deerfield, IL 60015, NDC 10019-079-01.DrugClass III1Completed
11 Aug 2023DIANEAL Low Calcium (2.5 mEq/L) Peritoneal Dialysis Solution 1.5% Dextrose, packaged in a) 2000 mL AMBU-FLEX II Container bag, Product Code L5B4825, NDC 0941-0409-06; b) 5000 mL AMBU-FLEX II Container bag, Product Code L5B4826, NDC 0941-0409-07; and c) 6000 mL AMBU-FLEX II Container bag, Product Code L5B9770, NDC…DrugClass II2Terminated
10 Aug 2023Baxter Epiphany Cardio Server E3 ECG Management System Servers with software versions: a) v6.1.x, b) v6.2.x, c) v7.0.x.DeviceClass II1Ongoing
10 Aug 2023Welch Allyn Connex Spot MonitorDeviceClass II1Ongoing
19 Jun 2023GEM FLOW COUPLER Monitor, PN 5156-00000-011DeviceClass II1Ongoing
15 Jun 2023SIGMA Spectrum Infusion Pump, Product Code 35700BAX2DeviceClass I2Ongoing
19 May 2023Voalte Patient Safety, Part Number 4.0, V4.0.000 to 4.0.401, used with the Centrella BedDeviceClass II2Ongoing
18 May 2023Allen Advance Chest Support with PadDeviceClass II1Ongoing
31 Mar 2023Hill-Rom pro+ mattress, product codes (REF): a) 20877002S, b) 20877003S, c) 20877004S, d) 20877007S, e) 20877008S, f) 21649301S, g) 21649401S, h) 21649402S, i) P006800A01, j) P006800A02, k) P3255A01, l) P3255A02, m) P3255A03, n) P3255ARENT01, o) P7923A01, p) P7923A02, q) P7923A03, r) P7923A04, s) P7924A01, t)…DeviceClass II1Ongoing
27 Mar 2023GEM NEUROTUBE, Absorbable Woven Polyglycolic Acid Mesh Tube, Product Codes: a) 5311-01240-010, b) 5311-01240-012; for peripheral nerve repairDeviceClass II1Ongoing
20 Mar 2023ExactaMed Oral Dispenser - 20 mL Clear Pharmacy Pack, REF H9387120; Oral medication syringeDeviceClass II1Ongoing
15 Mar 2023Dianeal Low Calcium (2.5 mEq/L) Peritonial Dialysis Solution with 1.5% Dextrose, packaged in a) 5000 mL per Ambu-Flex II Container bag, Product Code L5B4826, NDC 0941-0409-07; and b) 6000 mL per Ambu-Flex II Container bag, Product Code L5B9770, NDC 0941-0409-01, Rx Only, Baxter Healthcare Corporation, Deerfield, IL…DrugClass II2Completed
22 Feb 2023Automated Peritoneal Dialysis System. Used for automatic control of dialysis solution exchanges.DeviceClass II1Ongoing
1 Feb 2023Baxter MiniCap Disconnect Cap with Povidone-Iodine Solution, 5C4466P; Accessory to disposable administration set for peritoneal dialysisDeviceClass II1Ongoing
25 Jan 2023Life2000 Ventilator System, a) REF BT-20-0002, b) REF BT-20-0002A, ventilatory support for the care of individualsDeviceClass I4Ongoing
23 Nov 2022Revaclear 300 dialyzers. Indicated for treatment of chronic and acute renal failure by hemodialysis.DeviceClass II3Ongoing
23 Nov 2022Revaclear 400 Dialyzer. Product Code: 114746L. Used to treat chronic and acute renal failure by hemodialysis.DeviceClass II2Ongoing
31 Oct 2022Baxter Electrocardiograph, ELI 380 -DCS21DeviceClass II1Terminated
18 Oct 2022Hill-Rom Progressa Bed SystemDeviceClass II1Ongoing
30 Sep 2022Hillrom Centrella Hospital Bed with WatchCare Incontinence Management System, Product code/Part numbers: P7900B100193, P7900B100195, P7900B100230, P7900B100236, P7900B100239, P7900B100244, P7900B100256, P7900B100257, P7900B100259, P7900B100264, P7900B100268, P7900B100269, P7900B100292, P7900B100296, P7900B100302,…DeviceClass I5Ongoing
20 Sep 2022Allen Advance Table, RSP-ADVANCE TABLE: a) REF A-71100-US, #107003, b) A-71101-EU, #107003. operating room tableDeviceClass II6Terminated
14 Sep 2022Prismaflex M Set: M60 (product code 106696), M100 (product code 106697). For use in providing continuous fluid management and renal replacement therapies.DeviceClass II5Ongoing
2 Sep 2022Starling Monitor, Product code CMMST5 and Starling Monitor SV, Product code CMM-ST5 (same products); and accessories/spare parts Starling Battery Pack, Product Code CMABATT; and Starling Patient Cable, Product code CMASC10.DeviceClass III1Ongoing
9 Aug 2022Baxter CLEARLINK System, Non-DEHP Solution Set with DUO-VENT Spike, Product Code 2R8403. An in-line injection site.DeviceClass I1Terminated
4 Aug 2022Acetaminophen Injection, 10 mg/mL, 1,000 mg/100 mL, 100 mL VIAFLO container bag, Single Dose Container, For Intravenous Use Only, Rx Only, Baxter Healthcare Corporation, Deerfield, IL 60015 USA; NDC 36000-306-60DrugClass II1Terminated
22 Jul 2022Baxter DISCPAC Syringe Tip Caps, Self-Righting, Luer Slip, Yellow: a) 25 pack, REF H93866025, b) 100 pack, REF H93866100, c) 25 pack, REF H938690025DeviceClass II7Ongoing
14 Jul 2022The Exacta-Mix 2400 compounding system, manufactured by Baxter Healthcare Corporation, is a compounding device used in the pharmacy to compound multiple source ingredients into one final solution. This device is not intended for direct patient hook-up.DeviceClass II1Ongoing
24 Jun 2022Hill-Rom PRO+ 36" MRS Surface With X-Ray mattress, REF P7924A01; and REF P7924ARENT01, PRO+ MRS Rental Surface with X-Ray mattress.DeviceClass II7Ongoing
22 Jun 2022ABACUS TPN (Total Parenteral Nutrition) Calculation software, Product codes: 8300-0167 (Abacus V3.1 CE), 8300-0168 (Abacus V3.1 SE), 8300-0169 (Abacus V3.1 ME), 8300-0191 (Abacus V3.2 CE), 8300-0192 (Abacus V3.2 SE), 8300-0193 (Abacus V3.2 ME), 8300-3391 (Abacus V3.3 CE), 8300-3392 (Abacus V3.3 SE), and 8300-3393…DeviceClass I1Terminated
31 May 2022NaviCare Nurse Call/Voalte Nurse CallDeviceClass II1Ongoing
17 May 2022#1 MAC F/O LARYNGOSCOPE; F/O Laryngoscope Set-MAC; F/O Laryngoscope Set-MAC W/LEDDeviceClass II1Terminated
26 Apr 2022In-Line ventilator adaptorDeviceClass I2Terminated
21 Apr 202215 Liters Drain BagDeviceClass II6Terminated
13 Apr 2022NaviCare Nurse Call System provides a comprehensive communication and information system that places patient calls, staff calls, and emergency calls.DeviceClass II2Terminated
1 Apr 2022Flo-Thru Intraluminal Shunt. Used in coronary artery or peripheral vascular procedures. Used to shunt blood at the anastomosis to provide a temporary blood-free operative field for suturing while allowing blood to flow distal to the anastomosis.DeviceClass II1Terminated
15 Mar 2022PrisMax System, Product Code 955626DeviceClass II3Ongoing
25 Feb 2022MiniCap Extended Life PD Transfer Set Product Codes: 5C4482S, R5C4482, R5C4483, R5C4484DeviceClass II1Terminated
25 Feb 2022Baxter DISCPAC Syringe Tip Caps, Self-Righting, Luer Slip, Yellow, REF H93866100, 100 slip tip caps/package.DeviceClass II1Terminated
21 Feb 2022Liko Universal Twinbar 670 QRH, an accessory that can be used together with most Liko lifts, model numbers 3156087 and P3156087.DeviceClass II1Ongoing
14 Feb 2022Compella Bariatric Bed SystemDeviceClass II2Terminated
7 Jan 2022Baxter MiniCap Extended Life PD Transfer Set (Easy-Lock), 5C4449DeviceClass II11Ongoing
29 Dec 2021Baxter Spectrum IQ Infusion Pumps, Product code 3570009.DeviceClass I2Ongoing
29 Sep 2021Hemodialysis Delivery System, Software Version 2.x.DeviceClass II1Ongoing
22 Jul 2021Baxter PrismaFlex, REF numbers: a) 106696 (M 60 SET) b) 106697 (M 100 SET) Expansion: c) 107144 (TPE2000 SET) d) 115307 (M 150 SET) e) 115309 (ST 100 SET) f) 955467 (M 150 SET) g) 955468 (ST 100 SET) h) 955595 (M 100 SET) i) 955596 (ST 150 SET) Used with Prismaflex or PrisMax control units for continuous fluid…DeviceClass II2Terminated
7 Jul 2021Dose IQ Safety Software used with Spectrum IQ Infusion PumpDeviceClass I1Terminated
30 Jun 2021Sharesource Connectivity Platform for Use with the Amia Automated PD SystemDeviceClass II2Terminated
15 Jun 2021EASYGRIP FLO-41 US. For delivering hemostatic agents to bleeding sites through a trocar.DeviceClass II1Terminated
4 Jun 2021Spectrum IQ Infusion System with Dose IQ Safety Software, Product Code 3570009. for the controlled administration of fluids.DeviceClass I1Terminated
14 Apr 2021Gambro Cartridge Blood Set, Product Code 101025 - Product Usage: intended for single use in a hemodialysis treatment using the Phoenix Dialysis Delivery Systems.DeviceClass II1Terminated
19 Mar 2021Spectrum IQ - Infusion Pump - Product Usage: intended to be used for the controlled administration of fluids.DeviceClass II1Terminated
28 Jan 2021Prismaflex Control Unit - Product Usage: Used for Continuous Renal Replacement Therapy (CRRT).DeviceClass II4Terminated
7 Jan 2021The PrisMax System Version II Hemodialysis Delivery System: Automatic Repositioning System Pump Assembly, specifically tubing, Model Numbers: a) 955626 b) 955558 c) 955701 PrisMax V2 Preventive Maintenance Kit, Product Code SC616 ARPS PUMP, Product Code SC6035 ARPS Pump Assembly, Product Code SC6053DeviceClass II1Terminated
6 Jan 2021Infusion PumpDeviceClass II1Terminated
30 Dec 2020Gambro Cartridge Blood Set Prime Line, product code 101025 - Product Usage: intended for single use in a hemodialysis treatment using the Phoenix Dialysis Delivery Systems.DeviceClass II6Ongoing
28 Dec 2020FLOW 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.DeviceClass II1Ongoing
21 Dec 2020Baxter 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 without needles, thus eliminating the…DeviceClass II1Terminated
11 Dec 2020VERITAS 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.DeviceClass II1Terminated
23 Nov 2020Baxter SIGMA Spectrum Infusion Pump with Master Drug Library (Version 6) - Product Usage: intended to be used for the controlled administration of fluids.DeviceClass II4Ongoing
10 Nov 2020MiniCap Extended Life PD Transfer SetDeviceClass II1Terminated
7 Oct 2020Bupivacaine 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, NDC 36000-092-10DrugClass II1Terminated
30 Jun 2020Baxter SIGMA Spectrum Infusion Pump with Master Drug Library (Version 6)DeviceClass I4Terminated
2 Jun 2020Flow Coupler Monitor, GEM, Global Excellence Microsurgery, Rx OnlyDeviceClass II1Ongoing
17 Apr 2020Gambro Cartridge Blood Set Prime Line - Product Usage: is intended for single use in a hemodialysis treatment using Dialysis Delivery Systems.DeviceClass II4Terminated
7 Apr 2020Prismaflex Control UnitDeviceClass II1Terminated
5 Mar 2020GEM 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.DeviceClass II3Terminated
6 Feb 2020Prismaflex System, Prismaflex Control UnitDeviceClass II6Terminated
12 Dec 2019Clearlink 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.DeviceClass II2Ongoing
19 Nov 20190.9% Sodium Chloride Irrigation USP 5000 mL bags, Rx Only, Baxter Healthcare Corporation Deerfield, IL 60015, NDC 0338-0047-29DrugClass II1Terminated
15 Nov 2019Revaclear Capillary Dialyzer 300, REF Revaclear 300 Product Code 114745LDeviceClass II1Terminated
4 Oct 2019Prismaflex Control Unit, software versions below 7.21DeviceClass II5Ongoing
19 Sep 2019TherMax Blood Warmer UnitDeviceClass II1Terminated
18 Sep 2019EXACTAMIX 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 destination container in compounding of large-volume sterile…DeviceClass II1Terminated
13 Aug 2019EXACTAMED 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 administration of liquid medication and…DeviceClass III1Terminated
18 Jul 20190.9% Sodium Chloride Injection USP, 100 mL Viaflex Container, Rx Only, Baxter Healthcare Corporation, Deerfield, IL 60015, USA, NDC 0338-0049-38.DrugClass II1Terminated
27 Jun 2019EXACTAMED Oral Dispensers, 5mL, AMBER: PHARMACY PACK, REF H9388505, x500 PHARMACY PACK, REF H9388105, x100 COST CONTAINMENT, REF H93884205, x1500DeviceClass III1Terminated
13 Jun 2019Sevoflurane, USP Inhalation Anesthetic 250 mL bottles, Rx only, Manufactured for Baxter Healthcare Corporation Deerfield, IL 60015 USA, NDC 10019-651-64DrugClass II1Terminated
31 May 2019REVACLEAR 300 Dialyzer, Product Code 114745L Revaclear 300 and Revaclear 400 dialyzers are indicated for treatment of chronic and acute renal failure by hemodialysis.DeviceClass II2Terminated
2 Jan 2019Dianeal Low Calcium (2.5 mEq/L) Peritoneal Dialysis Solution with 1.5% Dextrose, 2000 mL UltraBag container bag, Rx only; Baxter Healthcare Corporation, Deerfield, IL 60015; Product Code 5B9766, NDC 0941-0424-52.DrugClass II1Terminated
11 Dec 2018AMIA 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.DeviceClass II2Terminated
2 Nov 2018GEM Coupler Forceps, GEM4183C, packaged individually.DeviceClass II1Ongoing
15 Oct 2018Metoprolol Tartrate Injection, USP, 5 mg/ 5 mL (1 mg/mL), 5 mL per sterile single use glass vial, Rx Only, Manufactured for: Claris Lifesciences, Inc., North Brunswick, NJ 08902. By: Claris Injectables Ltd., Gujarat, India. NDC: 36000-033-10DrugClass III1Terminated
10 Oct 2018L5C4531 X1 Integrated APD Set with Cassette 3-Prong Sterile, nonpyrogenic fluid path. Sterilized by ethylene oxide.DeviceClass II1Terminated
25 Sep 2018Levofloxacin Injection in 5% Dextrose, 5 mg/mL, packaged in a) 50 mL (NDC 36000-046-24), b) 100 mL (NDC 36000-047-24), c) 150 mL (NDC 36000-048-24) Container bags, Rx only, Manufactured for: Claris Lifesciences Inc., North Brunswick, NJ 08902; By: Claris Injectables Ltd., Gujarat, India.DrugClass III1Terminated
18 Sep 2018SPECTRUM IQ INFUSION SYSTEM WITH DOSE IQ SAFETY SOFTWARE, 3570009DeviceClass II1Terminated
12 Sep 2018EXACTAMIX Empty EVA Bags - 250 mL Product Usage: A plastic container used to hold large-volume sterile solutions to be administered to a patient through an intravascular administration set.DeviceClass II5Terminated
6 Sep 20180.9% Sodium Chloride Injection USP 50 mL Viaflex container Baxter Healthcare Corporation Deerfield, IL 60015 -- NDC 0338-0049-31DrugClass II1Terminated
21 Aug 20180.9% Sodium Chloride Injection USP 100 mL bags, Rx only, Baxter Healthcare Corporation Deerfield, IL 60015 USA, NDC 0338-0049-18DrugClass II1Terminated
1 Aug 2018Levofloxacin Injection in 5% Dextrose, 250 mg (5 mg/mL), 250 mg in 50 mL 5% Dextrose, 50 mL Single Use Container bag, Rx only, Manufactured for: Claris Lifesciences Inc., North Brunswick, NJ 08902; By: Claris Injectables Ltd., Gujarat, India, NDC 36000-046-24.DrugClass III3Terminated
12 Jul 2018power cord for: (a) AMIA Automated PD Cycler, Product Code: 5C9320; (b) Kaguya PD System, Product Code: T5C8500 (Japanese distribution only)DeviceClass II1Terminated
21 Jun 2018Baxter 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 pharmaceutical drugs, blood, blood products and…DeviceClass II1Terminated
30 May 2018FLOSEAL Special Applicator Tips in cartons labeled in part, "Floseal SPECIAL APPLICATOR TIPS***6 x Malleable Tip Trimmable Tip***Baxter***." The pouches inside the cartons are labeled in part, "Floseal SPECIAL APPLICATOR TIPS***Baxter***"."DeviceClass II1Ongoing
8 May 2018Baxter SIGMA Spectrum Infusion Pump with Master Drug Library (Version 6), infusion pump, 35700BAX and 35700ABB 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 pharmaceutical drugs, blood, blood…DeviceClass II2Terminated
25 Apr 2018Baxter EXACTAMIX Inlet, Non-Vented, High-Volume Inlet, REF H938173 Product Usage: Exacta-Mix 2400 Compounding System Administration set is a disposable component of a compounding device used in the pharmacy to compound multiple source ingredients into one final solution.DeviceClass II4Terminated
24 Apr 2018Prismaflex System, Product Code 107493 Intended Use: The Prismaflex Control Unit is intended for: " Continuous Renal Replacement Therapy (CRRT) for patients weighing 20 kilograms or more with acute renal failure and/or fluid overload. " Therapeutic Plasma Exchange (TPE) therapy for patients weighing 20 kilograms or…DeviceClass II5Terminated
3 Apr 2018Baxter Sigma Spectrum Infusion Pump with master Drug Library (Version 6) 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 includes pharmaceutical drugs, blood, blood products and mixture if…DeviceClass II5Terminated
6 Feb 2018Sterile EXACTAMED Oral Dispenser, Clear, Individually Packaged, 5 mL, Product Code H93876105DeviceClass II1Terminated
21 Dec 2017MARS Treatment Kit, Use only with MARS(R) Monitor 1TC, GAMBRO, Product Code 800541DeviceClass II1Terminated
10 Nov 2017Nexterone (amiodarone HCl) Premixed Injection, 150mg/100mL, 100-mL bag, Rx Only, Sterile, Baxter Healthcare Corporation, Deerfield, IL. NDC 43066-150-10DrugClass I1Terminated
6 Oct 2017Baxter SIGMA Spectrum Infusion Pump with Master Drug Library (Version 6) (GTIN 00085412091570); Model Numbers: 35700BAX and 35700ABB. Intended to be used for the controlled administration of fluids.DeviceClass II1Terminated
15 Sep 2017Intralipid 20%, A 20% I.V. Fat Emulsion, 100 ml bag, Rx only, Manufactured by Fresenius Kabi, Uppsala, Sweden for Baxter Healthcare Corporation, Deerfield, IL 60015 USA, NDC 0338-0519-58DrugClass I1Terminated
27 Jul 2017Empty IntraVia Container with Non-DEHP Fluid Path, 500mL Containers are intended for use in the preparation and administration of drug admixtures.DeviceClass II1Terminated
6 Jul 20170.9% Sodium Chloride Injection USP, 250 mL VIAFLEX Container bag, Rx only, Baxter Healthcare Corporation, Deerfield, IL 60015; Distributed in Canada by Baxter Corporation, Toronto, Ontario, Canada, Product Code: 2B1322, NDC 0338-0049-02.DrugClass II1Terminated
6 Jul 20175% Dextrose Injection, USP, 100 mL VIAFLEX Plastic Container, Rx only, Baxter Healthcare Corporation, Deerfield IL 60015 USA, Product Code: 2B0089, NDC: 0338-0017-38DrugClass II2Terminated
5 Jul 2017HomeChoice Automated PD system Model numbers: 5C4471, 5C4471R Product Usage: The HomeChoice Automated Personal Cycler is intended for automatic control of dialysate solution exchanges in the treatment of pediatric and adult renal failure patients undergoing peritoneal dialysis.DeviceClass II2Terminated
15 May 2017Fluconazole Injection, USP, 200 mg/100 mL (2mg/mL), 100 mL Single-Dose Intravia Container bag, Rx only, Baxter Healthcare Corporation, Deerfield, IL 60015 USA, Product Code 2J1446, NDC 0338-6046-48DrugClass II2Terminated
15 Feb 2017Prismaflex Control Unit. Dialyzer, high permeability with or without sealed dialysate system. Continuous Renal Replacement Therapy (CRRT) for patients weighing 20 kilograms or more with acute renal failure and/or fluid overload. *Therapeutic Plasma Exchange (TPE) therapy for patients weighing 20 kilograms or more…DeviceClass II1Terminated
26 Jan 2017Baxter SIGMA Spectrum Infusion Pump with Master Drug Library, Model #/Product Code 35700BAX2DeviceClass II1Terminated
4 Jan 2017Maintenance Kit PH1, Cod. 6997266 The Phoenix Hemodialysis delivery system is intended to be used to provide high flux and low flux hemodialysis, hemofiltration and ultrafiltration on patients weighing 15 Kilograms or more. The Phoenix system is to be used with either high or low permeability dialyzers. The device is…DeviceClass II2Terminated
16 Dec 2016APD Set with Cassette 3-Prong Peritoneal Dialysis Set Indicated for use in the treatment of patients with renal failure to provide PD fluid exchanges with Baxter HomeChoice PD systems in clinical and home use settings.DeviceClass II1Terminated
6 Dec 201610% Premasol sulfite-free (Amino Acid) Injection, 2000 mL bulk package, Rx only, Baxter Healthcare Corporation, Clintec Nutrition Division, Deerfield, IL 60015 USA, NDC 0338-1130-06DrugClass II1Terminated
6 Dec 2016Fluconazole Injection, USP, 200 mg/100 mL (2mg/mL), 100 mL Single-Dose Intravia Container bag, Rx only, Baxter Healthcare Corporation, Deerfield, IL 60015 USA, Product Code 2J1446, NDC 0338-6046-48.DrugClass II1Terminated
2 Sep 20150.9% Sodium Chloride Injection, USP, 100 mL MINI-BAG VIAFLEX Container, Single Dose Container, Rx Only, Baxter Healthcare Corporation, Deerfield, IL 60015, USA, NDC 0338-0049-38DrugClass II1Terminated
11 Jul 2014FlowCOUPLER. An implantable device that is used to detect blood flow in vessels. Used in the end-to-end anastomosis of veins and arteries normally encountered in microsurgical and vascular reconstructive procedures. The FlowCOUPLER System is intended to detect blood flow and confirm vessel patency intra-operatively…DeviceClass II1Terminated
28 Apr 2014Baxter MiniCap Extended Life PD Transfer Set with Twist Clamp - Extra Short. 1 Unit. Sterile. Baxter Healthcare Corporation, Deerfield, IL 60015 USADeviceClass II1Terminated
6 Jul 2011Sigma Spectrum VOLUMETRIC INFUSION PUMP, with or without Master Drug Library, Part Number 35700 -- Common/Classification Name: Infusion Pump -- Class 2 medical device -- SIGMA LLC, Medina, NY 14103 Product Usage: The Spectrum Infusion Pump is intended to be used for the controlled administration of intravenous…DeviceClass I1Terminated

An event with 1 product record and a class that is not Class I has no page. It has a row in this table.

Enforcement event: All the product records that have one FDA event number. This site shows one event on one page.

Recalling firm: The firm that the FDA record names for a recall.

Type and class

Baxter Healthcare Corporation: events for each product type
TypeEvents
Device159
Drug34
Baxter Healthcare Corporation: events in each class
ClassEvents
Class II150
Class I36
Class III7
Share of the events of the firm in Class I
19%
Share of all events on the register in Class I
18%
Events with the status Ongoing
111

openFDA, about the status: FDA does not update the status of a recall after the recall has been classified according to its level of hazard. As such, the status of a recall (open, completed, or terminated) will remain unchanged after published in the Enforcement Reports. Source: openFDA, Drug Recall Enforcement Reports, Disclaimer.

Events by year

FDA enforcement events of Baxter Healthcare Corporation, by the year that the recall started. The largest year is 2024, with 35 events.

Official channels

Cite this page

Recall Register. Baxter Healthcare Corporation: FDA recalls. https://recallregister.com/firm/baxter-healthcare-corporation/. Source: openFDA enforcement reports. Data through .

Sources

Source
openFDA enforcement reports
Licence
CC0 1.0
Export date
28 Sep 2026
State of the firm address
IL, NY

The firm name is the spelling in the FDA records. A company with 2 spellings has 2 pages.

A firm with more products can have more recalls. This site does not compare one firm with a different firm. How the register is made. Report an error.

Questions

Which classes do the FDA recalls of Baxter Healthcare Corporation have?
Class II: 150 events. Class I: 36 events. Class III: 7 events. The class is for the product of a recall. It is not a class of the firm.
Which product types do the FDA recalls of Baxter Healthcare Corporation have?
Device: 159 events. Drug: 34 events.
What is the newest FDA recall of Baxter Healthcare Corporation?
FDA event 99678, which the firm started on 17 Aug 2026. The first product in the record is: 0.9% Sodium Chloride Injection USP 500 mL, VIAFLEX Plastic Containers, with 24 units per case. Baxter Healthcare Corporation, Deerfield, IL, 60015, USA, Made in USA, NDC 0338-0049-03
How many FDA recalls of Baxter Healthcare Corporation have the status Ongoing?
111 events have the status Ongoing in the openFDA file. openFDA says about the status: FDA does not update the status of a recall after the recall has been classified according to its level of hazard. As such, the status of a recall (open, completed, or terminated) will remain unchanged after published in the Enforcement Reports.