PlainRecalls

Baxter Healthcare Corporation

286 recalls on record · Latest: Feb 25, 2026

Baxter Healthcare Corporation Recall Insight

Baxter Healthcare Corporation appears on 286 federal recall records indexed by PlainRecalls, out of 83,949 total recalls tracked across the FDA, CPSC, NHTSA, and USDA FSIS. That represents approximately 0.341% of the federal archive — a data point that is only interpretable alongside production volume, product mix, and decades of operation, because a high recall count alone does not establish fault. Large, diversified firms that sell tens of millions of units across many categories will mechanically accumulate more recall records than small manufacturers, even when their defect rates per unit shipped are comparable or lower. The most recent action on this firm is dated Feb 25, 2026, which is the anchor point for assessing whether enforcement is currently active or historical.

On this page of 36 entries, severity tagging shows 3 critical, 31 moderate, and 2 lower-severity recalls. Affected-unit counts are disclosed on 36 of 36 entries — unit-count disclosure is more common on CPSC and NHTSA actions and less common on FDA drug/device recalls, where lot numbers and distribution scope substitute for absolute totals. The records on this page span 4 distinct product categories, with issuing agencies dominated by FDA Devices (24), FDA Drug (12). The date window on this page runs from Jun 20, 2012 to Aug 15, 2018.

Manufacturer-level browsing is useful when monitoring a single firm for patterns — whether recalls cluster around one product family (suggesting a specific design or supplier issue) or scatter across the firm's entire catalog (which can indicate systemic quality-control problems or deliberate regulator attention). Clicking into each recall reveals the specific hazard, remedy, and distribution scope that together determine whether a consumer is actually at risk. For decisions that depend on being current — deciding whether a product in your home is safe, whether to return a gift, or whether to accept a replacement — always verify the recall number on the issuing agency's site, because federal agencies amend, terminate, and re-scope recalls over time and only the agency's live record reflects the current legal status. This page aggregates what agencies have published publicly and is intended for consumer awareness and research.

FDA Drug Low Aug 15, 2018

Levofloxacin Injection in 5% Dextrose, 750 mg (5 mg/mL), 750 mg in 150 mL 5% Dextrose, 150 mL Single Use Container bag, Rx only, Manufactured for: Cl…

FDA Drug Low Aug 15, 2018

Levofloxacin Injection in 5% Dextrose, 500 mg (5 mg/mL), 500 mg in 100 mL 5% Dextrose, 100 mL Single Use Container bag, Rx only, Manufactured for: Cl…

FDA Devices Moderate Jun 13, 2018

Baxter SIGMA Spectrum Infusion Pump with Master Drug Library (Version 8), infusion pump, 35700BAX2 Product Usage: The Baxter SIGMA Spectrum Infus…

FDA Devices Moderate Jun 13, 2018

Baxter SIGMA Spectrum Infusion Pump with Master Drug Library (Version 6), infusion pump, 35700BAX and 35700ABB Product Usage: The Baxter SIGMA Sp…

FDA Devices Moderate May 30, 2018

Prismaflex 7.20 US, Product Code 955542 Intended Use: The Prismaflex Control Unit is intended for: " Continuous Renal Replacement Therapy (CRRT) …

FDA Devices Moderate May 30, 2018

Baxter EXACTAMIX Inlet, Vented, High-Volume Inlet, REF H938174 Usage: Exacta-Mix 2400 Compounding System Administration set is a disposable compo…

FDA Devices Moderate May 30, 2018

Prismaflex System, Product Code 107493 Intended Use: The Prismaflex Control Unit is intended for: " Continuous Renal Replacement Therapy (CRRT) f…

FDA Devices Moderate May 30, 2018

Prismaflex 7.XX US, Product Code 115269 Intended Use: The Prismaflex Control Unit is intended for: " Continuous Renal Replacement Therapy (CRRT) …

FDA Devices Moderate May 30, 2018

Prismaflex 7.XX ROW, Product Code 114870 Intended Use: The Prismaflex Control Unit is intended for: " Continuous Renal Replacement Therapy (CRRT)…

FDA Devices Moderate May 30, 2018

Prismaflex 5.10 US, Product Code 113081 Intended Use: The Prismaflex Control Unit is intended for: " Continuous Renal Replacement Therapy (CRRT) …

FDA Devices Moderate May 16, 2018

Baxter Sigma Spectrum Infusion Pump with Master Drug Library (Version 6) 35700BAXR Product Usage: The Baxter Sigma Spectrum Infusion Pump with ma…

FDA Devices Moderate May 16, 2018

Baxter Sigma Spectrum Infusion Pump with Master Drug Library (Version 6) 35700BAXRE Product Usage: The Baxter Sigma Spectrum Infusion Pump with m…

FDA Devices Moderate May 16, 2018

Baxter Sigma Spectrum Infusion Pump with master Drug Library (Version 6) 35700BAX Product Usage: The Baxter Sigma Spectrum Infusion Pump with mas…

FDA Devices Moderate May 16, 2018

Baxter Sigma Spectrum Infusion Pump with master Drug Library (Version 6) 35700BAXL Product Usage: The Baxter Sigma Spectrum Infusion Pump with ma…

FDA Devices Moderate May 16, 2018

Baxter Sigma Spectrum Infusion Pump with Master Drug Library (Version 6) 35700BAXRP Product Usage: The Baxter Sigma Spectrum Infusion Pump with m…

FDA Devices Moderate Apr 11, 2018

Prismaflex Control Unit. Dialyzer, high permeability with or without sealed dialysate system. Continuous Renal Replacement Therapy (CRRT) for pat…

FDA Devices Moderate Mar 21, 2018

Baxter SIGMA Spectrum Infusion Pump with Master Drug Library (Version 6) (GTIN 00085412091570); Model Numbers: 35700BAX and 35700ABB. Intended to …

FDA Devices Moderate Mar 7, 2018

Sterile EXACTAMED Oral Dispenser, Clear, Individually Packaged, 5 mL, Product Code H93876105

FDA Drug Critical Feb 7, 2018

Nexterone (amiodarone HCl) Premixed Injection, 150mg/100mL, 100-mL bag, Rx Only, Sterile, Baxter Healthcare Corporation, Deerfield, IL. NDC 43066-15…

FDA Devices Moderate Feb 7, 2018

Empty IntraVia Container with Non-DEHP Fluid Path, 500mL Containers are intended for use in the preparation and administration of drug admixtures.

FDA Devices Moderate Jan 31, 2018

MARS Treatment Kit, Use only with MARS(R) Monitor 1TC, GAMBRO, Product Code 800541

FDA Drug Critical Nov 1, 2017

Intralipid 20%, A 20% I.V. Fat Emulsion, 100 ml bag, Rx only, Manufactured by Fresenius Kabi, Uppsala, Sweden for Baxter Healthcare Corporation, Deer…

FDA Devices Moderate Aug 23, 2017

HomeChoice Automated PD system Model numbers: 5C4471, 5C4471R Product Usage: The HomeChoice Automated Personal Cycler is intended for automatic …

FDA Devices Moderate Aug 23, 2017

HomeChoice Pro Automated PD system Model numbers: 5C8310, 5C8310R Product Usage: The HomeChoice Automated Personal Cycler is intended for automa…

FDA Drug Moderate Jul 19, 2017

0.9% Sodium Chloride Injection USP, 250 mL VIAFLEX Container bag, Rx only, Baxter Healthcare Corporation, Deerfield, IL 60015; Distributed in Canada…

FDA Drug Moderate Jul 19, 2017

5% Dextrose Injection, USP, 100 mL VIAFLEX Plastic Container, Rx only, Baxter Healthcare Corporation, Deerfield IL 60015 USA, Product Code: 2B0089, …

FDA Drug Moderate Jul 19, 2017

0.9% Sodium Chloride Injection, USP, 100 mL VIAFLEX Container, Rx Only, Baxter Healthcare Corporation, Deerfield IL 60015 USA, Product Code: 2B1309,…

FDA Drug Moderate May 24, 2017

Milrinone Lactate in 5% Dextrose Injection, 20 mg/100 mL, 100 mL Single-Dose Intravia Container bag, Rx only, Baxter Healthcare Corporation, Deerfiel…

FDA Drug Moderate May 24, 2017

Fluconazole Injection, USP, 200 mg/100 mL (2mg/mL), 100 mL Single-Dose Intravia Container bag, Rx only, Baxter Healthcare Corporation, Deerfield, IL …

FDA Devices Moderate Apr 5, 2017

Baxter SIGMA Spectrum Infusion Pump with Master Drug Library, Model #/Product Code 35700BAX2

FDA Devices Moderate Feb 1, 2017

Maintenance Kit PH2, Cod. 6997274 The Phoenix Hemodialysis delivery system is intended to be used to provide high flux and low flux hemodialysis, he…

FDA Devices Moderate Jan 25, 2017

APD Set with Cassette 3-Prong Peritoneal Dialysis Set Indicated for use in the treatment of patients with renal failure to provide PD fluid excha…

FDA Drug Moderate Jan 18, 2017

10% Premasol sulfite-free (Amino Acid) Injection, 2000 mL bulk package, Rx only, Baxter Healthcare Corporation, Clintec Nutrition Division, Deerfiel…

FDA Drug Moderate Dec 28, 2016

Fluconazole Injection, USP, 200 mg/100 mL (2mg/mL), 100 mL Single-Dose Intravia Container bag, Rx only, Baxter Healthcare Corporation, Deerfield, IL …

FDA Drug Moderate Sep 30, 2015

0.9% Sodium Chloride Injection, USP, 100 mL MINI-BAG VIAFLEX Container, Single Dose Container, Rx Only, Baxter Healthcare Corporation, Deerfield, IL …

FDA Devices Critical Jun 20, 2012

Sigma Spectrum VOLUMETRIC INFUSION PUMP, with or without Master Drug Library, Part Number 35700 -- Common/Classification Name: Infusion Pump -- Class…

Nearby Manufacturers

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Data Sources

  • Source: FDA + CPSC + NHTSA + USDA FSIS — federal recall filings naming this firm. Verify with FDA, CPSC, NHTSA, or USDA FSIS directly.
  • Source: PlainRecalls Manufacturer Index — firm-level aggregation across all four federal recall feeds