Medical device makerLabelled by claude-haiku-5.5 from the firm's FDA names. It is not an FDA field. in United StatesLabelled by claude-haiku-5.5 from the firm's FDA names. It is not an FDA field., part of Baxter InternationalLabelled by claude-sonnet-5.5 from the firm's FDA names. It is not an FDA field.. FDA records under 14 spellings of its name, each linked to the record.
As of Nov 15, 2026, FDA's public records list Baxter Healthcare with 568 510(k) clearances, 469 device recalls, 233 drug applications, 114 drug recalls, 3 complete response letters and 1 warning letter. The most recent is a 510(k) clearance dated Dec 16, 2025: Welch Allyn FlexiPort Blood Pressure Cuffs (FlexiPort Blood Pressure Cuffs).
Drug approvals, 510(k) clearances, recalls and letters, 2017 to 2026 to date
A hatched bar is a year that is not over, so its count covers only part of the year.
| Dec 16, 2025 | Welch Allyn FlexiPort Blood Pressure Cuffs (FlexiPort Blood Pressure Cuffs)K251745 · DXQ | 510(k) clearances |
| Jul 28, 2025 | Spectrum IQ Infusion System with Dose IQ Safety Software (3570009)K251636 · FRN | 510(k) clearances |
| Jul 28, 2025 | SIGMA Spectrum Infusion Pump with Master Drug LibraryK251640 · FRN | 510(k) clearances |
| Mar 14, 2025 | Solution Administration SetsK243529 · FPA | 510(k) clearances |
| Feb 28, 2025 | Intravascular Extension Sets and AccessoriesK242339 · FPA | 510(k) clearances |
| Sep 5, 2024 | Novum IQ Syringe Pump (40800BAXUS)K242390 · FRN | 510(k) clearances |
| Aug 2, 2024 | Actifuse ABX; Actifuse MIS; Actifuse Shape; ALTAPORE; ALTAPORE SHAPE; ALTAPORE MISK241564 · MQV | 510(k) clearances |
| Mar 29, 2024 | Novum IQ Large Volume PumpK211122 · FRN | 510(k) clearances |
| Mar 29, 2024 | Complete response letter, NDA 218224Unapproved | Complete response letters |
| Mar 27, 2024 | Complete response letter, NDA 218408Unapproved | Complete response letters |
| Jul 25, 2023 | Warning letter: Cleaning validation, Process validation, Out-of-specificationCDER | Warning letters |
| Jun 30, 2021 | Sharesource Connectivity Platform for Use with the Amia Automated PD SystemClass II · Baxter Healthcare Corporation has identified that the AMIA Sharesource User Guide that is used with the AMIA Automated P | Device recalls |
| Jun 30, 2021 | Kaguya Automated Peritoneal Dialysis SystemClass II · Baxter Healthcare Corporation has identified that the AMIA Sharesource User Guide that is used with the AMIA Automated P | Device recalls |
| Apr 29, 2021 | Complete response letter, NDA 213645Approved | Complete response letters |
| Jul 5, 2018 | Warning letter: Data integrity, Sterility assurance, Method validationCDER | Warning letters |
| Jun 3, 2015 | Heparin Sodium and 0.9% Sodium Chloride Injection, 1000 USP Heparin Units, 500 mL in a VIAFLEX Plus Container, Rx Only, Baxter Healthcare CoClass II · Subpotent Drug; out of specification results for heparin raw material | Drug recalls |
| Mar 23, 2015 | 0.9% Sodium Chloride Injection, USP, 50 mL, VIAFLEX Plastic Container Multi Pack, Rx Only, Baxter Healthcare Corporation, Deerfield, IL , PrClass II · Lack of Assurance of Sterility; increased complaints received for leaks | Drug recalls |
| Mar 23, 2015 | Clinimix E 5/20 sulfite-free (5% amino-acid with electrolytes in 20% dextrose with calcium) Injection, 2000 mL in Dual Chamber Container, RxClass II · Lack of Assurance of Sterility; increased complaints received for leaks | Drug recalls |
| Dec 4, 2014 | 0.9% Sodium Chloride Injection USP, 100 mL MINI-BAG Plus Container, Rx only, Baxter Healthcare Corporation, Deerfield, IL 60015, USA, ProduClass I · Presence of Particulate Matter: Confirmed customer complaints received for the presence of blue plastic, identified as | Drug recalls |
| Sep 8, 2014 | Potassium Chloride Injection, 10 mEq per 100 mL, Highly Concentrated (100 mEq/L), 100 mL Sterile single dose container bags, Rx only, BaxterClass II · Correct Labeled Product Mispack: Shipping cartons labeled as containing Potassium Chloride injection actually contained | Drug recalls |
| Aug 4, 2014 | ProSol - sulfite-free (Amino Acid) Injection, 20%, 2000 mL VIAFLEX container bag, Rx only, Baxter Healthcare Corporation, Clinitec NutritionClass II · Presence of Particulate Matter: identification of particulates in a retention sample that have been identified as a mixt | Drug recalls |
Spellings are joined only when they reduce to the same name, or a reviewed source names the same company. Sharing an FDA establishment number (FEI) is not enough: contract sites make products for many firms. Facts marked AI were labelled by a language model from the firm's FDA names; everything else comes from FDA or Wikidata. How this page is built
