PlainRecalls

Baxter Healthcare Corporation

Compiled from official public sources by the editorial team.

405 recalls on record · Latest: Apr 8, 2026

Baxter Healthcare Corporation Recall Insight

Baxter Healthcare Corporation appears on 405 federal recall records indexed by PlainRecalls, out of 101,704 total recalls tracked across the FDA, CPSC, and NHTSA. That represents approximately 0.398% 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 Apr 8, 2026, which is the anchor point for assessing whether enforcement is currently active or historical.

On this page of 50 entries, severity tagging shows 8 critical, 41 moderate, and 1 lower-severity recalls. Affected-unit counts are disclosed on 36 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 2 distinct product categories, with issuing agencies dominated by FDA Devices (42), FDA Drug (8). The date window on this page runs from Mar 8, 2023 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 (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 Devices Moderate Mar 20, 2024

STERIS Boot Assembly, Traction Device, OT 1000, Part Number REF 10009192

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 Critical Feb 28, 2024

Baxter Exactamix Pro 1200, REF EXM12DY

FDA Devices Critical Feb 28, 2024

Baxter Exactamix Pro 2400, REF EXM24DY

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 Jan 17, 2024

Baxter Preveleak Surgical Sealant, Product Codes: ADS201808

FDA Devices Moderate Jan 17, 2024

Baxter Ostene Hemostasis Material, Product Codes: a) 1503831, 3.5 G; b) 1503832, 2.5 G; c) 1503833, 1.0 G

FDA Devices Moderate Jan 17, 2024

Baxter Vascular Probe, Product Codes: a) 7081015: 8CM, 1- 1.5 MM GLOBAL, b) 7081520: 8CM, 1.5-2 MM GLOBAL, c) 7082025: 8CM, 2-2.5 MM GLOB…

FDA Devices Moderate Jan 17, 2024

Peri-Guard Repair Patch, Product Codes: a) PG1016 : 10 X 16 CMUS, TS b) PG1225: 12 X 25 CMUS, TS c) PG0404: 4 X 4 CMUS, TS d) PG0608: 6 X 8C…

FDA Devices Moderate Jan 17, 2024

Baxter FloSeal Hemostatic Matrix RECOTHROM, Product Codes: a) ADS202105, 5mL-6 PK US b) ADS202110, 10mL US

FDA Devices Moderate Jan 17, 2024

Q-Stress Cardiac Stress Testing System, version 6, with below product name / product codes: a) QS6 AM12Q KIT AHA XML / QS6-BXXCS: b) QS6 AM12Q KIT B…

FDA Devices Moderate Jan 17, 2024

XScribe Cardiac Stress Testing System, version 6, with below product names and codes: a) XS6/RS6 REVIEW WKSTN KIT, XR-6AC-BXXXX; b) XS6/RS6 REVIEW W…

FDA Devices Moderate Jan 17, 2024

Peri-Guard Repair Patch, Product Codes: a) PC1016NBIO: 10X16CMUS, b) PC1225NBIO: 12X25CMUS, c) PC0404NBIO: 4X4CMUS, d) PC0608NBIO: 6X8CMUS…

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 Critical Nov 15, 2023

Novum IQ Syringe infusion system, Product Code 40800BAXUS

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 Critical Jul 19, 2023

SIGMA Spectrum Infusion Pump, Product Code 35700BAX2

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 May 3, 2023

GEM NEUROTUBE, Absorbable Woven Polyglycolic Acid Mesh Tube, Product Codes: a) 5311-01240-010, b) 5311-01240-012; for peripheral nerve repair

FDA Devices Moderate Apr 26, 2023

ExactaMed Oral Dispenser - 20 mL Clear Pharmacy Pack, REF H9387120; Oral medication syringe

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 Critical Mar 8, 2023

Life2000 Ventilator PKG, Hospital, a) REF BT20007, b) REF BT-20-0007, ventilatory support for the care of individuals

FDA Devices Critical Mar 8, 2023

Life2000 Ventilator System, a) REF BT-20-0002, b) REF BT-20-0002A, ventilatory support for the care of individuals

Nearby Manufacturers

Other firms with recall activity tracked in the PlainRecalls index.

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Data Sources

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

Every figure on PlainRecalls is rendered directly from official FDA, CPSC and NHTSA recall records, no number is typed in by an editor. Recalls are aggregated across FDA, CPSC and NHTSA filings that name this firm; the total reflects the federal record, not an independent investigation. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error. Data current as of July 2026.