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 50 entries, severity tagging shows 5 critical, 43 moderate, and 2 lower-severity recalls. Affected-unit counts are disclosed on 42 of 50 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 3 distinct product categories, with issuing agencies dominated by FDA Devices (42), FDA Drug (8). The date window on this page runs from Aug 31, 2022 to Apr 3, 2024.

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 Devices Moderate Apr 3, 2024

Baxter Supple Peri-Guard Repair Patch (legacy product codes): a) PC0404SNBIO, b) PC0608NSBIO, c) PC0814SNBIO, d) PC1016SNBIO

FDA Devices Moderate Apr 3, 2024

Baxter Peri-Guard Repair Patch (new product codes): a) PG0404, b) PG0608, c) PG0814, d) PG1016, e) PG1225

FDA Devices Moderate Apr 3, 2024

Baxter Peri-Guard Repair Patch (legacy product codes): a) PC0404NBIO, b) PC0608NBIO, c) PC0814NBIO, d) PC1016NBIO

FDA Devices Moderate Apr 3, 2024

Baxter Supple Peri-Guard Repair Patch (new product codes): a) SPG0404, b) SPG0406, c) SPG0608, d) SPG0814, e) SPG1016

FDA Devices Moderate Mar 27, 2024

HDS Traction Boot II, REF AR-6529-23, The Traction Boot is designed to position, support and/or distract the patient's foot for hip surgery

FDA Devices Moderate Mar 20, 2024

CLEARLINK Non-DEHP Solution Set Luer Lock Adapter, Product Code 2R8401

FDA Drug Moderate Feb 28, 2024

Norepinephrine Bitartrate in 5% Dextrose Injection, 8 mg/ 250 mL (32 mcg/mL), For Intravenous Infusion Only, 250 mL vial, Rx Only, Baxter Healthcare …

FDA Devices Moderate Jan 17, 2024

Baxter Flo-Thru Intraluminal Shunt, Product Codes: a) Product Code FT12100, 1.00 GLOBAL; b) Product Code FT12125, 1.25 GLOBAL; c) Product Code …

FDA Devices Moderate Jan 17, 2024

Baxter Floseal Hemostatic Matrix Fast Prep, Product Codes: a) ADS201844, 5 mL b) ADS201845, 10mL

FDA Devices Moderate Jan 17, 2024

Vascu-Guard Peripheral Vascular Patch (US), Product Codes: a) VG0108: 0.8 X 8 CM US, TS; b) VG0110: 1 X 10 CM US, TS; c) VG0106: 1 X 6 CM US,…

FDA Devices Moderate Jan 17, 2024

XScribe CP Cardiac Stress Testing System, version 6, with below product names and codes: a) X-SCRIBE CPI KIT WIRELESS USB 608 MHz, 41000-030-50; b) …

FDA Devices Moderate Jan 17, 2024

Baxter FloSeal Hemostatic Matrix NL, 5 mL, Product Codes: ADS201883

FDA Devices Moderate Jan 17, 2024

Baxter Flo-Rester, Disposable internal vessel occluder, distributed in the following sizes: a) Product Code 50100: 12MM, 1.00 MM GLOBAL; b) Produ…

FDA Devices Moderate Jan 17, 2024

PERI-GUARD SUPPLE, Product Codes: a) SPG1016: 10X16 CM US, TS; b) SPG0404: 4 X 4 CM US, TS; c) SPG0608: 6 X 8 CM US, TS; d) SPG0814: 8 X…

FDA Devices Moderate Jan 17, 2024

Baxter Coseal Premix, Surgical Sealant, Product Codes: a) 934070; b) 934071; c) 934072

FDA Devices Moderate Jan 17, 2024

Vascu-Guard Peripheral Vascular Patch (GLOBAL), Product Codes: a) VG0108N: 0.8X8 CM GLOBAL, b) VG0110N: 1X10 CM GLOBAL, c) VG0106N: 1X6 CM…

FDA Devices Moderate Dec 20, 2023

Baxter Amia Automated Peritoneal Dialysis (APD) Cycler Set, REF 5C5479

FDA Drug Moderate Dec 13, 2023

Ondansetron Injection, USP, 4 mg/2 mL (2 mg/mL), 2 mL per vial, Rx only, Manufactured for: Baxter Healthcare Corporation, Deerfield, IL 60015 USA. M…

FDA Devices Moderate Nov 8, 2023

HILLROM PROGRESSA+ BED, Product Codes: P7501A000016, P7501A000019, P7501A000031, P7501A000032, P7501A000033, P7501A000052, P7501A000053, P7501A00005…

FDA Drug Moderate Oct 25, 2023

Doxil (doxorubicin hydrochloride liposome injection) 50 mg in 25 mL (2 mg/mL), Single-Dose Vial, Rx only, Manufactured for: Baxter Healthcare Corpora…

FDA Devices Moderate Oct 4, 2023

Baxter Epiphany Cardio Server E3 ECG Management System Servers with software versions: a) v6.1.x, b) v6.2.x, c) v7.0.x.

FDA Devices Moderate Sep 20, 2023

Welch Allyn Connex Spot Monitor

FDA Drug Moderate Sep 6, 2023

Dianeal PD-2 Peritonial Dialysis Solution with 1.5% Dextrose, 5000 mL AMBU-FLEX ll Container with yellow pull ring, Rx Only, Baxter Healthcare Corpor…

FDA Drug Moderate Sep 6, 2023

DIANEAL 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, …

FDA Drug Low Aug 30, 2023

Bendamustine HCl Injection, 100mg/4mL (25mg/mL), One 4 mL Multiple-Dose Vial, Rx only, Manufactured for Baxter Healthcare Corporation, Deerfield, IL …

FDA Devices Moderate Jul 26, 2023

GEM FLOW COUPLER Monitor, PN 5156-00000-011

FDA Devices Critical Jul 19, 2023

The Spectrum IQ Infusion System with Dose IQ Safety Software, Product Code 3570009

FDA Devices Moderate Jul 19, 2023

Allen Advance Chest Support with Pad

FDA Devices Moderate Jul 5, 2023

NaviCare Patient Safety V3.9.200 to 3.9.600, used with the Centrella Bed

FDA Devices Moderate Jul 5, 2023

Voalte Patient Safety, Part Number 4.0, V4.0.000 to 4.0.401, used with the Centrella Bed

FDA Devices Moderate May 10, 2023

Hill-Rom pro+ mattress, product codes (REF): a) 20877002S, b) 20877003S, c) 20877004S, d) 20877007S, e) 20877008S, f) 21649301S, g) 21649401S, h) 21…

FDA Drug Moderate May 3, 2023

Dianeal PD-2 Peritonial Dialysis Solution with 1.5% Dextrose, 3000 mL per Ambu-Flex II Container bag, Rx Only, Baxter Healthcare Corporation, Deerfie…

FDA Drug Moderate May 3, 2023

Dianeal 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 …

FDA Devices Moderate Apr 5, 2023

Automated Peritoneal Dialysis System. Used for automatic control of dialysis solution exchanges.

FDA Devices Moderate Mar 15, 2023

Baxter MiniCap Disconnect Cap with Povidone-Iodine Solution, 5C4466P; Accessory to disposable administration set for peritoneal dialysis

FDA Devices Critical Mar 8, 2023

Life2000 Ventilator PKG, Hospital, a) REF BT200011, b) REF BT-20-0011, ventilatory support for the care of individuals

FDA Devices Moderate Dec 28, 2022

Revaclear 300 dialyzers. Indicated for treatment of chronic and acute renal failure by hemodialysis.

FDA Devices Moderate Dec 28, 2022

Revaclear 400 dialyzers. Indicated for treatment of chronic and acute renal failure by hemodialysis.

FDA Devices Moderate Nov 23, 2022

Hill-Rom Progressa Bed System

FDA Devices Critical Nov 9, 2022

Hillrom Hospital Bed Accessory, Watch Care Incontinence Management System for Progressa Bed, Product Code/Part Number P00697903.

FDA Devices Moderate Nov 9, 2022

Simple Clamp, US/EURO Rails, UPPER EXTREMITY DISTRACTION CMPT, REF F-40018, #800101. To position, support and/or distract the patients hand, wrist, …

FDA Devices Moderate Nov 9, 2022

Allen Standard Starburst, Mayfield/Doro, STANDARD SPINE POSITIONERS CMPT, REF A-70710, #800103. Component to position and support the patients hea…

FDA Devices Critical Nov 9, 2022

Hillrom Hospital Bed Accessory, Watch Care Incontinence Management System for Centrella Bed, Product Code/Part Number P00697905

FDA Devices Moderate Oct 19, 2022

Prismaflex HF20 Set (product code 109841). For use in providing continuous fluid management and renal replacement therapies.

FDA Devices Moderate Oct 19, 2022

Prismaflex ST Set: ST60 (product code 107643), ST100 (product code 107636), ST150 (product code 107640). For use in providing continuous fluid mana…

FDA Devices Moderate Oct 19, 2022

Prismaflex M Set: M60 (product code 106696), M100 (product code 106697). For use in providing continuous fluid management and renal replacement the…

FDA Devices Low Oct 5, 2022

Starling Monitor, Product code CMMST5 and Starling Monitor SV, Product code CMM-ST5 (same products); and accessories/spare parts Starling Battery Pa…

FDA Devices Critical Sep 21, 2022

Baxter CLEARLINK System, Non-DEHP Solution Set with DUO-VENT Spike, Product Code 2R8403. An in-line injection site.

FDA Devices Moderate Aug 31, 2022

Baxter DISCPAC Syringe Tip Caps, Self-Righting, Luer Slip, Dark Blue: a) 25 pack REF H938693025, b) 100 pack REF H938673100

FDA Devices Moderate Aug 31, 2022

The Exacta-Mix 2400 compounding system, manufactured by Baxter Healthcare Corporation, is a compounding device used in the pharmacy to compound multi…

Nearby Manufacturers

Other firms with recall activity tracked in the PlainRecalls index.

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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