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Baxter Healthcare Corporation

250 FDA 510(k) clearances · Recalling firm

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RecordFirmDate
Baxter MiniCap Extended Life PD Transfer Set with Twist Clamp, Part Number R5C4484; use in recall (Z-0380-2025)Baxter Healthcare Corporation2024-11-20
Baxter MiniCap Extended Life PD Transfer Set with Twist Clamp, Part Number T5C4482; use in recall (Z-0381-2025)Baxter Healthcare Corporation2024-11-20
Baxter MiniCap Extended Life PD Transfer Set with Twist Clamp EX Short, Part Number T5C448 recall (Z-0382-2025)Baxter Healthcare Corporation2024-11-20
Baxter AK 98 Dialysis Machine, Hemodialysis Delivery System, Product Code 955607. As of Fe recall (Z-0327-2025)Baxter Healthcare Corporation2024-11-13
Baxter Spectrum IQ Infusion System with Dose IQ Safety Software, Product Code 3570009 recall (Z-0348-2025)Baxter Healthcare Corporation2024-11-08
Hillrom Welch Allyn HScribe Holter System; ambulatory monitoring recall (Z-0320-2025)Baxter Healthcare Corporation2024-11-07
Hillrom Welch Allyn Q-Stress Cardiac Stress Testing System; cardiac stress test recall (Z-0321-2025)Baxter Healthcare Corporation2024-11-07
Hillrom Welch Allyn RScribe 12-Lead Electrocardiograph System; Electrocardiograph recall (Z-0322-2025)Baxter Healthcare Corporation2024-11-07
Hillrom Welch Allyn Vision Express Holter Analysis System; Electrocardiograph recall (Z-0323-2025)Baxter Healthcare Corporation2024-11-07
Hillrom Welch Allyn Diagnostic Cardiology Suite (formerly Connex Cardio); Diagnostic spiro recall (Z-0324-2025)Baxter Healthcare Corporation2024-11-07
Hillrom Welch Allyn XScribe Cardiac Stress Testing System; Programmable Diagnostic Compute recall (Z-0325-2025)Baxter Healthcare Corporation2024-11-07
a. Hillrom Centrella Smart+ Medical-Surgical Hospital Bed, Product codes: P7900B000001, P7 recall (Z-0228-2025)Baxter Healthcare Corporation2024-10-25
Baxter Operating table TruSystem 7000 U (MB), Product codes: a) REF 1604786; b) REF 160478 recall (Z-0210-2025)Baxter Healthcare Corporation2024-10-24
Baxter Operating Table TruSystem 7000, Product code REF 1841046 recall (Z-0211-2025)Baxter Healthcare Corporation2024-10-24
Baxter Operating Table TruSystem 7000 (MBW), Product code REF 1841048 recall (Z-0212-2025)Baxter Healthcare Corporation2024-10-24
Baxter Operating Table TruSystem 7000 (dV), Product code REF 1841049 recall (Z-0213-2025)Baxter Healthcare Corporation2024-10-24
Baxter Operating Table TruSystem 7000 V, Product code REF 1841050 recall (Z-0214-2025)Baxter Healthcare Corporation2024-10-24
Baxter Operating Table TruSystem 7000 (MBW) V, Product code REF 1841082 recall (Z-0215-2025)Baxter Healthcare Corporation2024-10-24
Baxter Operating Table TruSystem 7000 (dV) V, Product code REF 1841083 recall (Z-0216-2025)Baxter Healthcare Corporation2024-10-24
Baxter Operating Table TruSystem 7000 U14 (MBW), Product code REF 2065385 recall (Z-0217-2025)Baxter Healthcare Corporation2024-10-24
Baxter Operating Table TruSystem 7000 U14 (MBW) V, Product code REF 2065386 recall (Z-0218-2025)Baxter Healthcare Corporation2024-10-24
Welch Allyn Life2000 Ventilation System, REF MS-01-0118, within exterior carton codes: 1) recall (Z-0046-2025)Baxter Healthcare Corporation2024-10-22
Baxter EXACTAMIX Inlet, Non-Vented, High Volume Inlet, REF H938173, for use in a pharmaceu recall (Z-3082-2024)Baxter Healthcare Corporation2024-09-19
Baxter EXACTAMIX Inlet, Vented, High Volume Inlet, REF H938174, for use in a pharmaceutica recall (Z-3083-2024)Baxter Healthcare Corporation2024-09-19
Baxter EXACTAMIX Inlet, Vented, Micro-Volume Inlet, REF H938175, for use in a pharmaceutic recall (Z-3084-2024)Baxter Healthcare Corporation2024-09-19
Baxter EXACTAMIX Inlet, Vented, Syringe Inlet, REF H938176, for use in a pharmaceutical co recall (Z-3085-2024)Baxter Healthcare Corporation2024-09-19
Baxter Spectrum Wireless Battery Modules A/B/G/N, product code 35223, used with either of recall (Z-2581-2024)Baxter Healthcare Corporation2024-08-16
Spectrum Wireless Battery Modules A/B/G/N, product code 36010, used with either of the fol recall (Z-2582-2024)Baxter Healthcare Corporation2024-08-16
Baxter SIGMA Spectrum Infusion Pump, Product Code: 35700BAX2 recall (Z-2530-2024)Baxter Healthcare Corporation2024-08-07
Baxter PST 500 U, Precision Surgical Table, Part number (product code) 4080300 recall (Z-2512-2024)Baxter Healthcare Corporation2024-08-06
Volara System. Single Patient Use (SPU) Circuit 5kit for Volara and Single Patient Use (SP recall (Z-2321-2024)Baxter Healthcare Corporation2024-07-17
Volara System. Blue Ventilator Adapter Module. Intermittent positive pressure breathing de recall (Z-2322-2024)Baxter Healthcare Corporation2024-07-17
Braun Thermoscan PRO 6000 Ear Thermometer recall (Z-2339-2024)Baxter Healthcare Corporation2024-07-11
Welch Allyn CP150 Electrocardiograph with Spirometry Option, Product Code: CP150A-1ENB. Th recall (Z-2323-2024)Baxter Healthcare Corporation2024-07-10
VidiaPort carrying arm, mount for auxiliary products, model numbers: a) 4028110 (Ceiling S recall (Z-2313-2024)Baxter Healthcare Corporation2024-07-05
Trulight 5000/3000 Surgical Light, model numbers: a) 4038210 (Duo Surgical Lights}; b) 403 recall (Z-2314-2024)Baxter Healthcare Corporation2024-07-05
iLED 7 surgical lights, Model Numbers: a) 4068110 (Ceiling Single Surgical Light); b) 4068 recall (Z-2315-2024)Baxter Healthcare Corporation2024-07-05
Life2000 Ventilator, Product Code: MS-01-0118, which is contained in the Life2000 Ventilat recall (Z-2140-2024)Baxter Healthcare Corporation2024-06-26
Centrella Max - The Centrella Smart+ Bed is intended for use in healthcare environments as recall (Z-2151-2024)Baxter Healthcare Corporation2024-06-14
Spectrum IQ Infusion pump, Product Code 357009 recall (Z-1810-2024)Baxter Healthcare Corporation2024-05-13
Baxter Spectrum IQ Infusion Pump, Product Code 3570009 recall (Z-1775-2024)Baxter Healthcare Corporation2024-05-03
Baxter Seprafilm Adhesion Barrier 1 Half Sheet, 5-PK, REF 664103, for use in abdominal and recall (Z-1689-2024)Baxter Healthcare Corporation2024-04-25
Surgical Tools and Cardiovascular Specialty marketing brochures, Reference numbers: US-AS1 recall (Z-1522-2024)Baxter Healthcare Corporation2024-04-12
Surgical Tools and Cardiovascular Specialty marketing brochures, Reference numbers: US-AS1 recall (Z-1523-2024)Baxter Healthcare Corporation2024-04-12
Surgical Tools and Cardiovascular Specialty marketing brochures, Reference numbers: US-AS1 recall (Z-1524-2024)Baxter Healthcare Corporation2024-04-12
Hillrom Welch Allyn Connex ProBP 3400 Digital Blood Pressure Device, marketed under the fo recall (Z-1509-2024)Baxter Healthcare Corporation2024-04-10
Hillrom Welch Allyn Spot Vision Screener VS100, marketed under the following models: a) SP recall (Z-1510-2024)Baxter Healthcare Corporation2024-04-10
Power Cords, marketed under the following models: a) CORD,METAL EARTH PIN, 2.5A,250V,2.5M, recall (Z-1511-2024)Baxter Healthcare Corporation2024-04-10
Hill-Rom PRO+ 36" MRS Surface, REF P7924A03, The pro+ mattress is intended for patient sup recall (Z-1400-2024)Baxter Healthcare Corporation2024-03-29
Baxter Peri-Guard Repair Patch (legacy product codes): a) PC0404NBIO, b) PC0608NBIO, c) PC recall (Z-1377-2024)Baxter Healthcare Corporation2024-03-26
Baxter Supple Peri-Guard Repair Patch (legacy product codes): a) PC0404SNBIO, b) PC0608NSB recall (Z-1378-2024)Baxter Healthcare Corporation2024-03-26
Baxter Peri-Guard Repair Patch (new product codes): a) PG0404, b) PG0608, c) PG0814, d) PG recall (Z-1379-2024)Baxter Healthcare Corporation2024-03-26
Baxter Supple Peri-Guard Repair Patch (new product codes): a) SPG0404, b) SPG0406, c) SPG0 recall (Z-1380-2024)Baxter Healthcare Corporation2024-03-26
HDS Traction Boot II, REF AR-6529-23, The Traction Boot is designed to position, support a recall (Z-1329-2024)Baxter Healthcare Corporation2024-03-20
CLEARLINK Non-DEHP Solution Set Luer Lock Adapter, Product Code 2R8401 recall (Z-1291-2024)Baxter Healthcare Corporation2024-03-14
STERIS Boot Assembly, Traction Device, OT 1000, Part Number REF 10009192 recall (Z-1289-2024)Baxter Healthcare Corporation2024-03-12
Baxter Exactamix Pro 1200, REF EXM12DY recall (Z-1001-2024)Baxter Healthcare Corporation2024-02-16
Baxter Exactamix Pro 2400, REF EXM24DY recall (Z-1002-2024)Baxter Healthcare Corporation2024-02-16
Q-Stress Cardiac Stress Testing System, version 6, with below product name / product codes recall (Z-0705-2024)Baxter Healthcare Corporation2024-01-10
XScribe Cardiac Stress Testing System, version 6, with below product names and codes: a) X recall (Z-0706-2024)Baxter Healthcare Corporation2024-01-10
XScribe CP Cardiac Stress Testing System, version 6, with below product names and codes: a recall (Z-0707-2024)Baxter Healthcare Corporation2024-01-10
Baxter Flo-Rester, Disposable internal vessel occluder, distributed in the following sizes recall (Z-0656-2024)Baxter Healthcare Corporation2024-01-05
Baxter Coseal Premix, Surgical Sealant, Product Codes: a) 934070; b) 934071; c) 934072 recall (Z-0657-2024)Baxter Healthcare Corporation2024-01-05
Baxter Ostene Hemostasis Material, Product Codes: a) 1503831, 3.5 G; b) 1503832, 2.5 G; c) recall (Z-0658-2024)Baxter Healthcare Corporation2024-01-05
Baxter Vascular Probe, Product Codes: a) 7081015: 8CM, 1- 1.5 MM GLOBAL, b) 7081520: 8CM, recall (Z-0659-2024)Baxter Healthcare Corporation2024-01-05
Baxter Preveleak Surgical Sealant, Product Codes: ADS201808 recall (Z-0660-2024)Baxter Healthcare Corporation2024-01-05
Baxter Floseal Hemostatic Matrix Fast Prep, Product Codes: a) ADS201844, 5 mL b) ADS201845 recall (Z-0661-2024)Baxter Healthcare Corporation2024-01-05
Baxter FloSeal Hemostatic Matrix RECOTHROM, Product Codes: a) ADS202105, 5mL-6 PK US b) AD recall (Z-0662-2024)Baxter Healthcare Corporation2024-01-05
Baxter Flo-Thru Intraluminal Shunt, Product Codes: a) Product Code FT12100, 1.00 GLOBAL; b recall (Z-0663-2024)Baxter Healthcare Corporation2024-01-05
Peri-Guard Repair Patch, Product Codes: a) PG1016 : 10 X 16 CMUS, TS b) PG1225: 12 X 25 CM recall (Z-0664-2024)Baxter Healthcare Corporation2024-01-05
Peri-Guard Repair Patch, Product Codes: a) PC1016NBIO: 10X16CMUS, b) PC1225NBIO: 12X25CMUS recall (Z-0665-2024)Baxter Healthcare Corporation2024-01-05
Vascu-Guard Peripheral Vascular Patch (US), Product Codes: a) VG0108: 0.8 X 8 CM US, TS; b recall (Z-0666-2024)Baxter Healthcare Corporation2024-01-05
Baxter FloSeal Hemostatic Matrix NL, 5 mL, Product Codes: ADS201883 recall (Z-0667-2024)Baxter Healthcare Corporation2024-01-05
PERI-GUARD SUPPLE, Product Codes: a) SPG1016: 10X16 CM US, TS; b) SPG0404: 4 X 4 CM US, TS recall (Z-0668-2024)Baxter Healthcare Corporation2024-01-05
Vascu-Guard Peripheral Vascular Patch (GLOBAL), Product Codes: a) VG0108N: 0.8X8 CM GLOBAL recall (Z-0669-2024)Baxter Healthcare Corporation2024-01-05
Baxter Amia Automated Peritoneal Dialysis (APD) Cycler Set, REF 5C5479 recall (Z-0550-2024)Baxter Healthcare Corporation2023-12-14
Novum IQ Syringe infusion system, Product Code 40800BAXUS recall (Z-0151-2024)Baxter Healthcare Corporation2023-11-09
HILLROM PROGRESSA+ BED, Product Codes: P7501A000016, P7501A000019, P7501A000031, P7501A000 recall (Z-0212-2024)Baxter Healthcare Corporation2023-11-02
Baxter Epiphany Cardio Server E3 ECG Management System Servers with software versions: a) recall (Z-2647-2023)Baxter Healthcare Corporation2023-09-28
Welch Allyn Connex Spot Monitor recall (Z-2581-2023)Baxter Healthcare Corporation2023-09-12
GEM FLOW COUPLER Monitor, PN 5156-00000-011 recall (Z-2208-2023)Baxter Healthcare Corporation2023-07-20
SIGMA Spectrum Infusion Pump, Product Code 35700BAX2 recall (Z-2103-2023)Baxter Healthcare Corporation2023-07-13
The Spectrum IQ Infusion System with Dose IQ Safety Software, Product Code 3570009 recall (Z-2104-2023)Baxter Healthcare Corporation2023-07-13
Allen Advance Chest Support with Pad recall (Z-2109-2023)Baxter Healthcare Corporation2023-07-07
Voalte Patient Safety, Part Number 4.0, V4.0.000 to 4.0.401, used with the Centrella Bed recall (Z-2006-2023)Baxter Healthcare Corporation2023-06-26
NaviCare Patient Safety V3.9.200 to 3.9.600, used with the Centrella Bed recall (Z-2007-2023)Baxter Healthcare Corporation2023-06-26
Hill-Rom pro+ mattress, product codes (REF): a) 20877002S, b) 20877003S, c) 20877004S, d) recall (Z-1482-2023)Baxter Healthcare Corporation2023-05-01
GEM NEUROTUBE, Absorbable Woven Polyglycolic Acid Mesh Tube, Product Codes: a) 5311-01240- recall (Z-1461-2023)Baxter Healthcare Corporation2023-04-25
ExactaMed Oral Dispenser - 20 mL Clear Pharmacy Pack, REF H9387120; Oral medication syring recall (Z-1420-2023)Baxter Healthcare Corporation2023-04-20
Automated Peritoneal Dialysis System. Used for automatic control of dialysis solution exch recall (Z-1316-2023)Baxter Healthcare Corporation2023-04-01
Baxter MiniCap Disconnect Cap with Povidone-Iodine Solution, 5C4466P; Accessory to disposa recall (Z-1213-2023)Baxter Healthcare Corporation2023-03-03
Life2000 Ventilator System, a) REF BT-20-0002, b) REF BT-20-0002A, ventilatory support for recall (Z-1139-2023)Baxter Healthcare Corporation2023-02-24
Life2000 Ventilator PKG, Hospital, a) REF BT20007, b) REF BT-20-0007, ventilatory support recall (Z-1140-2023)Baxter Healthcare Corporation2023-02-24
Life2000 Ventilator PKG, Hospital, a) REF BT200011, b) REF BT-20-0011, ventilatory support recall (Z-1141-2023)Baxter Healthcare Corporation2023-02-24
Life2000 Ventilator , REF MS-01-0118, ventilatory support for the care of individuals recall (Z-1142-2023)Baxter Healthcare Corporation2023-02-24
Baxter Electrocardiograph, ELI 380 -DCS21 recall (Z-1013-2023)Baxter Healthcare Corporation2023-01-24
Revaclear 400 Dialyzer. Product Code: 114746L. Used to treat chronic and acute renal failu recall (Z-0760-2023)Baxter Healthcare Corporation2022-12-22
Revaclear 400 Dialyzer. Product Code: 114749M. Not distributed in the USA. Used to treat c recall (Z-0761-2023)Baxter Healthcare Corporation2022-12-22
Revaclear 300 dialyzers. Indicated for treatment of chronic and acute renal failure by hem recall (Z-0762-2023)Baxter Healthcare Corporation2022-12-22
Revaclear 400 dialyzers. Indicated for treatment of chronic and acute renal failure by hem recall (Z-0763-2023)Baxter Healthcare Corporation2022-12-22
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Every clearance here is in the API, with alerts when new ones post.