Baxter Healthcare Corporation
Baxter Healthcare Corporation holds FDA 510(k) medical device clearances, first cleared 2004, most recent 2025, with 378 FDA device recalls on record.
Top product codes for Baxter Healthcare Corporation
FDA recalls by Baxter Healthcare Corporation
10 most recent of 378- Z-3065-2026 — Baxter Novum IQ Syringe Pump, Model Number 40800BAXUS
- Z-3066-2026 — Baxter Novum IQ Syringe Pump, Loaner, Model Number 40800BAXUSL
- Z-2766-2026 — Baxter Duo-Vent Solution Set and Male Luer Lock Adapter, Product Code 1C8507; Solution Administration Sets
- Z-2550-2026 — Hillrom VOLARA System P.CIRCUIT KIT AC (Single Patient Use Circuit), Model/Catalog Number REF M08473; Oscillation Lung Expansion Therapy, positive pressure breathing device
- Z-2551-2026 — Hillrom VOLARA System P.CIRCUIT 5KIT AC, (Single Patient Use Circuit), Model/Catalog Number REF M08474; Oscillation Lung Expansion Therapy, positive pressure breathing device
- Z-2548-2026 — Hillrom VOLARA System P.CIRCUIT KIT (Single Patient Use Circuit), Model/Catalog Number REF M08085; Oscillation Lung Expansion Therapy, positive pressure breathing device
- Z-2549-2026 — Hillrom VOLARA P.CIRCUIT 5KIT (System Single Patient Use Circuit), Model/Catalog Number REF M08270; Oscillation Lung Expansion Therapy, positive pressure breathing device
- Z-2262-2026 — Brand 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.
- Z-2638-2026 — Adapter 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 tables
- Z-1637-2026 — Blue Ventilator Adapter Module, single-patient use circuit, Product Code M07937. Accessory to Baxter Volara Respiratory Therapy system.
Recalls are matched by FDA's recalling-firm name — openFDA's enforcement dataset doesn't reference 510(k) numbers, so a recall here may cover devices beyond this company's 510(k) clearances.
Recent clearances by Baxter Healthcare Corporation
- K251745 — Welch Allyn FlexiPort Blood Pressure Cuffs (FlexiPort Blood Pressure Cuffs)
- K251636 — Spectrum IQ Infusion System with Dose IQ Safety Software (3570009)
- K251640 — SIGMA Spectrum Infusion Pump with Master Drug Library
- K243529 — Solution Administration Sets
- K242339 — Intravascular Extension Sets and Accessories
- K242390 — Novum IQ Syringe Pump (40800BAXUS)
- K241564 — Actifuse ABX; Actifuse MIS; Actifuse Shape; ALTAPORE; ALTAPORE SHAPE; ALTAPORE MIS
- K211122 — Novum IQ Large Volume Pump
- K230665 — Dose IQ Safety Software
- K232467 — CleanCart A, CleanCart C, AK 98 Hemodialysis Machine
- K230022 — Baxter SIGMA Spectrum Infusion Pump with Master Drug Library
- K230041 — Spectrum IQ Infusion System with Dose IQ Safety Software
- K223175 — lntravascular Administration Sets with Stopcock and Manifold
- K220558 — Blood Administration Sets
- K212262 — PCA Syringe Sets
- K222048 — Spectrum IQ Infusion System with Dose IQ Safety Software
- K211124 — Dose IQ Safety Software
- K211125 — Novum IQ Syringe Pump
- K220417 — Spectrum IQ Infusion System with Dose IQ Safety Software
- K212216 — Prismaflex ST60 Set, Prismaflex ST100 Set, Prismaflex ST150 set
- K214016 — 15L Cycler Drainage Bag
- K213639 — Revaclear 500, Revaclear 400, Revaclear 300
- K211649 — PCEA Syringe Set
- K211035 — U9000 Plus Ultrafilter
- K203609 — Intravascular Administration Sets
- K210430 — Intravascular Extension Set
- K210335 — Blood Administration Set
- K201867 — Homechoice Claria APD System, Sharesource Connectivity Platform for Use with the Homechoice Claria APD System
- DEN190042 — Theranova Dialyzers, Theranova 400 Dialyzer, Theranova 500 Dialyzer
- K192366 — Intravascular Extension Sets and Accessories
- K201464 — Altapore MIS
- K200640 — ALTAPORE SHAPE
- K193482 — PrisMax System Version 3
- K192363 — Altapore
- K191513 — Altapore Shape
- K180739 — Clearlink System Solution Set
- K181225 — ALTAPORE
- K181306 — Actifuse Flow
- K173084 — Spectrum IQ Infusion System, Dose IQ Safety Software
- K171671 — Prismaflex System 8.10
- K172544 — IV Fat Emulsion Administration Sets
- K161808 — Solution Set with 1.2 Micron Air Eliminating Filter
- K162887 — PrismaSATE
- K160007 — Paclitaxel Sets
- K161323 — Solution Set for Epidural Use
- K153158 — Solution Administration Sets with 0.2 Micron Filter
- K152129 — FlexiCap Disconnect Cap with Povidone-Iodine Solution, MiniCap with Povidone-Iodine Solution
- K150860 — Nitroglycerin Sets with DUO-VENT Spike
- K142600 — VIAL-MATE Adaptor
- K142011 — SOLUTION SET/EXTENSION SET
- K133801 — BAXTER SIGMA SPECTRUM INFUSION PUMP WITH MASTER DRUG LIBRARY
- K121634 — INTERLINK SYSTEM EXTENSION SET WITH CONTROL-A-FLO-REGULATORY CLEARLINK SYSTEM EXTENSION SET WITH CONTROL-A-FLO-REGULATOR
- K112893 — CLEARLINK LUER ACTIVATED VALVE, CLEARLINK SYSTEM NON-DEHP CATHETER EXTENSION SETS
- K092318 — BAXJECT II HI-FLOW NEEDLELESS TRANSFER DEVICE
- K083778 — XENIUM XPH, MODELS 110, 130, 150, 170, 190 AND 210
- K090096 — ALL-IN-ONE CONTAINER
- K073571 — TRICOS T RESORBABLE BONE SUBSTITUTE
- K062079 — XENIUM DIALYZER, MODELS 110, 130, 150, 170, 190 AND 210
- K062457 — INFUSOR SMALL VOLUME ELASTOMERIC INFUSION DEVICES
- K053539 — MERIDIAN HEMODIALYSIS MACHINE, MODEL 5M5576
- K041738 — BAXTER INFUSOR SV (SMALL VOLUME); BAXTER INFUSOR LV (LARGE VOLUME)
Data sourced from openFDA. This site is unofficial and independent of the FDA.