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Baxter Healthcare Corporation

Baxter Healthcare Corporation Recalls

All product recalls associated with Baxter Healthcare Corporation.

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Recall Summary

Total Recalls

1000

Past Year

567

Class I (Serious)

Most Recent

Jan 2026

Data from FDA, USDA, CPSC, and NHTSA public records. Recall counts vary by company size, industry, and reporting practices. Always check official sources for current information.

Showing 821–840 of 7756 recalls

Welch Allyn CP150 Electrocardiograph (Baxter) – EMI Absorber Missing (2024)

During manufacturing, the step to install an Electromagnetic Interference (EMI) Absorber was omitted. The purpose of the EMI absorber is to prevent EMI leakage that might potentially affect other devices in the vicinity or the device itself may be vulnerable to EMI resulting in device malfunction or unavailability.

FDAJun 3, 2024IL• Baxter Healthcare Corporation

Thyroid Formula Capsules (Penn Herb) – Salmonella risk (2024)

Salmonella

Potential Salmonella contamination

Class IHigh

FDAJun 3, 2024CA, FL, IL +7 more• Penn Herb Company, Ltd.

Volara System Circuit (Baxter) – Handset Plug Disconnect (2024)

Potential of the handset plug to disconnect from the nebulizer port on the blue ventilator adapter. The handset plug is required to ensure proper operation and ventilator gas flow.

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FDAMay 30, 2024Nationwide• Baxter Healthcare Corporation

Volara System Blue Ventilator Adapter (Baxter Healthcare) – Disconnection Risk (2024)

Potential of the handset plug to disconnect from the nebulizer port on the blue ventilator adapter. The handset plug is required to ensure proper operation and ventilator gas flow.

FDAMay 30, 2024Nationwide• Baxter Healthcare Corporation

Super Vinegar Cleaner (Compare Brands) – poisoning risk (2024)

Fire/Burn Risk

This recall involves the ADIOS! Super Vinegar All Natural Cleaner, 30%. The cleaner's bottles are labeled on the front with: "ADIOS! SUPER VINEGAR ALL NATURAL CLEANER. 30% Concentrate Indoor & Outdoor use". There is a label on the back with: "Say ADIOS to industrial cleaners with the natural power of vinegar" along with safety information and instructions. The product was sold in a 16 oz. white bottle with a blue cap.

CPSCMay 30, 2024Nationwide• Compare Brands LLC, of Fort Wayne, Indiana

Life2000 Ventilator (Baxter Healthcare) – Battery Charging Failure (2024)

Potential for certain Life2000 ventilator systems to either fail to charge or have intermittent charging behavior due to damage to the battery charger dongle. Damage of the battery charger dongle prevents the ventilator's internal battery from charging.

FDAMay 29, 2024Nationwide• Baxter Healthcare Corporation

Phenazopyridine HCl Tablets (Winder) – Product Mix Up (2024)

Product Mix Up. A bottle of Phenazopyridine HCl tablets USP 100 mg contained Phenobarbital tablets 16.2 mg.

Class IIModerate

FDAMay 28, 2024Nationwide• Winder Laboratories, LLC

Beckman Coulter IGM Reagent (Beckman Coulter) – Lipemia Result Inaccuracy (2024)

LIH Influence check settings for Lipemia are incorrect which may result patient samples being reported as false low results or cause a high result to report as normal

FDAMay 27, 2024Nationwide• Beckman Coulter Inc.

Suntegrity Sunscreen (Synchronicity) – CGMP Deviations (2024)

CGMP Deviations

Class IIModerate

FDAMay 24, 2024Nationwide• SYNCHRONICITY SPA INC, DBA SUNTE

Suntegrity Sunscreen (Synchronicity) – Microbial Contamination (2024)

Microbial Contamination of Non-Sterile Products: Presence of Aspergillus Sydowii (Mold)

Class IHigh

FDAMay 24, 2024Nationwide• SYNCHRONICITY SPA INC, DBA SUNTE

Zoledronic Acid Injection (Dr. Reddy's) – Sterility Concern (2024)

Lack of Assurance of Sterility: Leaking vials

Class IIModerate

FDAMay 23, 2024Nationwide• Dr. Reddy's Laboratories, Inc.

CentriMag Primary Console (Thoratec) – Power Standard Nonconformance (2024)

Due to a component change, the console part of a circulatory support system may not conform to the IEC 61000-4-5 standard, so if subjected to a power surge above 1.8kV and up to 2.0 kV, the console may shut down completely without alarm, pumping would cease, and the patient would have to be switched to a backup circulatory support system.

FDAMay 22, 2024Nationwide• Thoratec Switzerland GMBH Technoparkstrasse 1 Zurich Switzerland

DxI 9000 Access Analyzer (Beckman Coulter) – Laboratory System Compatibility (2024)

When a DxI 9000 Access Immunoassay Analyzer is connected to a Laboratory Automation System (LAS) and is running with the system software versions 1.17.0 and below, the analyzer does not send a message to the LAS when the sample wheel is full, and the LAS continues sending samples despite the limited capacity to process new samples. Therefore, sample tests may be aliquoted but not processed when the number of tests associated with onboard patient samples exceeds the throughput limit. If this issue occurs test results are flagged with a sample wheel timeout (SWT) error flag, and there may be a delay in reporting test results which could lead to a delay in patient treatment.

FDAMay 22, 2024Nationwide• Beckman Coulter, Inc.

Beckman Coulter DxI 9000 Analyzer (Beckman Coulter) – System Connectivity (2024)

The reason for this recall is Beckman Coulter has determined that when a DxI 9000 Access Immunoassay Analyzer is connected to a Laboratory Automation System (LAS); is running with the software versions 1.17 and below; and a sample tube is sent from the LAS to DxI 9000 Access Immunoassay Analyzer, an out of sequence message will be sent from the Analyzer to the LAS. This issue may result in multiple error messages (i.e., a sample pick and place (PnP) error or a no result obtained (NRT) flag may be displayed) and subsequently a risk of delays in processing/reporting patient test results and patient treatment.

FDAMay 22, 2024Nationwide• Beckman Coulter, Inc.

BRAUNABILITY CHRYSLER WHEELCHAIR VAN (BRAUNABILITY) – Seat Mechanism Issue (2024)

The Braun Corporation (Braun) is recalling certain 2023-2024 Chrysler Voyager vehicles, equipped with certain GO-ES Space Saver Foldaway Seats. The recliner mechanism may not engage when the seat back is fully reclined. As such, these vehicles fail to comply with the requirements of Federal Motor Vehicle Safety Standard number 210, "Seat Belt Assembly Anchorages."

NHTSAMay 17, 2024Nationwide• BRAUNABILITY

Duloxetine Capsules (Breckenridge) – Impurity Concern (2024)

CGMP Deviations: Presence of N-nitroso-duloxetine impurity above FDA recommended interim limit

Class IIModerate

FDAMay 17, 2024Nationwide• Breckenridge Pharmaceutical, Inc

BIOFIRE FILMARRAY GI Panel (BioFire) – False Positive Results (2024)

Due to increase of false positive Vibrio/Vibrio Cholerae results when using a certain transport medium.

FDAMay 16, 2024Nationwide• BioFire Diagnostics, LLC

Super Lube Products (Kano Laboratories) – Poisoning Risk (2024)

Fire/Burn Risk

The recall involves Super Lube products which include the following: Syncopen Synthetic Penetrant, Fire Resistant Hydraulic Fluid, and Metal Protectant and Corrosion Inhibitor. The products are used to prevent corrosion in various machinery. Super Lube Syncopen Synthetic Penetrant was sold in a four-ounce white spray bottle (item number 85004), a 32-ounce or one-quart trigger spray black plastic bottle (item number 85032), and a one-gallon (item number 85010) white plastic bottle with a handle. The container bears the brand Super Lube followed by a flag of green, blue, orange, and yellow stripes. Super Lube Fire Resistant Hydraulic Fluid was sold in a one-gallon white plastic bottle (item number 86010) with a handle. Super Lube Metal Protectant & Corrosion Inhibitor was sold in a 32-ounce or one-quart trigger spray black plastic bottle with a handle (item numbers 83032 / 83032A). The Super Lube products have one of the following lot numbers located on the bottom or rear label: Super Lube Syncopen Synthetic Penetrant Size Item Number Lot Number 1.0 Gallon Bottle 85010 17348 L24 - 23320 K26 1.0 Quart Trigger Sprayer 85032 17290 J35 - 23320 K26 4 ounce Bottle 85004 17348 L24 - 23320 K26 Super Lube Fire Resistant Hydraulic Fluid Size Item Number Lot Number 1 Gallon Bottle 86010 16120 D48 - 24040 B16 Super Lube Metal Protectant & Corrosion Inhibitor Size Item Number 1 Quart Trigger Sprayer 83032 / 83032A 17348 L24 - 23297 J49

CPSCMay 16, 2024Nationwide• Kano Laboratories LLC, of Bohemia, New York

Ventilator HAMILTON-C6 (Hamilton Medical) – Sensor Fail Mode (2024)

Ventilator may enter sensor fail mode, ventilation may not re-initiate, after patient is reconnected, which may cause hypoxia, if this sequence occurs: 1)User presses O2 enrichment, 2)User disconnects endotracheal tube for open suctioning, 3)Sensor error initiated, sensor fail mode occurs, 4)Patient is re-connected with sensor fail mode active, 5) Ventilation is not re-initiated by the ventilator.

FDAMay 15, 2024Nationwide• Hamilton Medical AG Via Crusch 8 Bonaduz Switzerland

Xstar Safety Slit Knife (Beaver Visitec) – Blade Configuration Error (2024)

The wrong configuration of the blade was in the package. The bevel was on the opposite side, instead of being in front (bevel up) it was in the back (bevel down).

FDAMay 10, 2024Nationwide• Beaver Visitec International, Inc.