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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 541–560 of 7756 recalls

Sigma Spectrum Infusion System (Baxter) – mounting screw issue (2025)

There is the potential for missing motor mounting screws, which may have occurred during the servicing process.

FDAFeb 5, 2025Nationwide• Baxter Healthcare Corporation

Access 2 Analyzer (Beckman Coulter) – sample motor alignment (2025)

Beckman Coulter identified that an issue for Access 2 Sample Motors (B48016) due to improper alignment, causing the motors to rub against the sample wheelbase plate and index sensor. The issue was traced to a worn tool used in production (at the supplier), affecting Access 2 sample motors. This could lead to a potential delay in reporting patient test results.

FDAFeb 5, 2025Nationwide• Beckman Coulter, Inc.

IntelePACS Software (Intelerad) – image calculation error (2025)

A software application that receives digital images and data from various sources has a bug in specific software versions that will calculate the Standard Uptake Value (SUV) incorrectly for PET/CT studies acquired on the days of Daylight Savings Time (DST); only on dates in which DST transition occurs; all other dates are unaffected. An incorrect SUV may lead to an incorrect diagnosis.

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FDAFeb 5, 2025Nationwide• INTELERAD MEDICAL SYSTEMS INCORPORATED 800, Boul. de Maisonneuve Est 12th floor Montreal Canada

HemosIL LMW Heparin Controls (Instrumentation Laboratory) – QC results (2025)

Multiple complaints indicating lower than expected quality control (QC) results and in some instances QC recovery below the lower limit of the package insert acceptance range when testing is performed with HemosIL Liquid Anti-Xa and HemosIL Heparin Calibrator. In some complaints, failure to pass QC resulted in patient testing delays.

FDAFeb 3, 2025Nationwide• Instrumentation Laboratory

Access Erythropoietin (Beckman Coulter) – reagent lot variation (2025)

Affected lot (439363) exhibited a negative dose drop of -22% with native patient samples compared to alternate reagent lots. Patient samples tested with the affected lot may demonstrate repeatable falsely decreased results, which may lead to improper diagnosis or repeat testing.

FDAFeb 3, 2025AL, AZ, AR +21 more• Beckman Coulter, Inc.

SIGNA MR380 MRI System (GE Healthcare) – SAR monitoring (2025)

For certain MR systems, a scan can be resumed following a Power Monitor trip when the "6-minute average SAR" is above the limit indicated on the "SAR Display". The user interface may incorrectly enable a scan to proceed earlier than intended. If resumed by the operator, such a scan can result in potential excessive tissue heating, especially if the patient is in contact with a conductive material or has an implant.

FDAJan 31, 2025Nationwide• GE Healthcare (China) Co., Ltd. 1F-5F BLD 1, No.1 Tongji South Road, Beijing Economic-Technological Development Area Beijing China

Refillable Medicine Bottles (Cabinet Health) – Child-Resistance Failure (2025)

This recall involves certain Cabinet Health 4 oz. Refillable Medicine Bottles with ABS plastic lids. The bottles are made of clear glass with blue, turquoise, orange or purple plastic lids labeled \"CABINET.\" Cabinet Health sold the bottles filled with over-the-counter drugs or as empty 4 oz. bottles. The recalled empty 4 oz. bottles were sold via cabinethealth.com from March 2023 through July 2024. Consumers with recalled empty bottles can identify them by the date of purchase. The recalled bottles filled with over-the-counter drugs have the following date codes on a sticker on the bottom of the bottle. Medication Name Lid Color Date Codes Tension Headache - Refillable Glass Bottle (Acetaminophen 500mg Caffeine 65mg) - 100 Count Blue 2029J07223 2029J07623 2029J07723 Allergy Relief - Refillable Glass Bottle (Diphenhydramine HCl 25mg) - 120 Count Turquoise 2265J07323 Pain Reliever and Nighttime Sleep Aid - Refillable Glass Bottle (Acetaminophen 500mg, Diphenhydramine 25mg) - 120 Count Blue 2127J06823 2127J23323 3040J23323 3051J23323 3051J23423Pain Reliever and Fever Reducer - Refillable Glass Bottle (Acetaminophen 500mg) - 120 Count Blue 2286J06323 2286J06523 2286J06623 2287J06623 2287J06723 Cough Relief - Refillable Glass Bottle (Dextromethorphan Hbr 15mg) - 60 Count Orange 2010J06923 2010J07023 3004J29623 3010J29623 3025J29623 Sleep Aid - Refillable Glass Bottle (Diphenhydramine HCl 50mg) - 70 Count Purple 3021J06823 3021J06923 3034J23423 3034J23523

CPSCJan 30, 2025Nationwide• Cabinet Health Inc., of Washington, D.C.

Potassium Chloride Tablets (Harvard Drug) – Dissolution Failure (2025)

Failed Dissolution Specifications.

Class IIModerate

FDAJan 30, 2025Nationwide• The Harvard Drug Group LLC dba Major Pharmaceuticals and Rugby Laboratories

Dark Chocolate Pretzels (Woodstock Farms) – Undeclared Milk (2025)

Undeclared Allergen

Undeclared Allergen - Milk

Class IHigh

FDAJan 27, 2025NY• United Natural Trading Inc. dba Woodstock Farms

Lorazepam Tablets 1mg (Major) – Potency Concern (2025)

Failed impurities/degradation specifications and Sub-potent Drug: Out-of-specification results were obtained during routine stability testing for Assay and Impurities.

Class IIModerate

FDAJan 21, 2025Nationwide• The Harvard Drug Group LLC dba Major Pharmaceuticals and Rugby Laboratories

Lorazepam Tablets 0.5mg (Major) – Potency Concern (2025)

Failed impurities/degradation specifications and Sub-potent Drug: Out-of-specification results were obtained during routine stability testing for Assay and Impurities.

Class IIModerate

FDAJan 21, 2025Nationwide• The Harvard Drug Group LLC dba Major Pharmaceuticals and Rugby Laboratories

Lorazepam Tablets 2mg (Major) – Potency Concern (2025)

Failed impurities/degradation specifications and Sub-potent Drug: Out-of-specification results were obtained during routine stability testing for Assay and Impurities.

Class IIModerate

FDAJan 21, 2025Nationwide• The Harvard Drug Group LLC dba Major Pharmaceuticals and Rugby Laboratories

RayStation Planning System (RaySearch) – density uncertainty (2025)

Inconsistency in the use of Density uncertainty in the RayStation functions Robust optimization, Robust evaluation and Compute perturbed dose for proton and light ion treatment plans when a HU-to-mass density CT calibration curve used in RayStation version 4.5 to 2024B including some service packs.

FDAJan 16, 2025Nationwide• RAYSEARCH LABORATORIES AB Eugeniavagen 18c Stockholm Sweden