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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 801–820 of 7756 recalls

Dianeal Low Calcium Dialysis Solution (Baxter) – Sterility Risk (2024)

Lack of Assurance of Sterility: Potential presence of leaks originating from the Connector Assembly component.

Class IIModerate

FDAJun 17, 2024Nationwide• Baxter Healthcare Corporation

Methylphenidate Hydrochloride (Trigen) – Dissolution Failure (2024)

Failed dissolution specifications: this product is being recalled due to this batch not meeting dissolution specifications.

Class IIModerate

FDAJun 17, 2024Nationwide• Trigen Laboratories

Alinity hq Analyzer (Abbott) - Sample Processing Issue (2024)

1)If Complete Blood Count with differential and reticulocyte(CBC+Diff+Retic) sample is run, then immediately following on same rack CBC+Diff sample is run, then falsely low red blood cell count may occur, generating falsely high Mean Cell Hemoglobin(MCH)/MCHC and falsely low hematocrit results. 2)Cell events may be incorrectly counted as basophil(BASO), resulting in increased BASO and %BASO counts

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FDAJun 14, 2024Nationwide• Abbott Laboratories

SIGMA Spectrum Infusion Pump (Baxter) - Testing Concern (2024)

Improperly performed testing prior to release

FDAJun 14, 2024Nationwide• Baxter Healthcare Corporation

Chemistry Analyzer (Beckman Coulter) - Carousel Motion Error (2024)

Beckman Coulter, Inc. has identified a rise in reagent carousel motion errors in Access 2 Immunoassay System Analyzers that appear to be caused by misaligned index wheels housed within the reagent carousel module. Customers affected by this issue may observe an increase in reagent carousel motion errors or QSMC errors that occur while unloading or loading reagent packs during system initialization and sample processing, which causes a non-operational system status and cancels tests; and patient results may be delayed if these errors cancel test processing.

FDAJun 14, 2024Nationwide• Beckman Coulter, Inc.

Braun Thermoscan PRO 6000 (Baxter) - Outdated Instructions (2024)

The Braun Thermoscan PRO 6000 ear thermometers may have been shipped with a compact disc (CD) containing an outdated version of the Instructions for Use (IFU).

FDAJun 13, 2024Nationwide• Baxter Healthcare Corporation

Autotome RX Sphincterotome (Boston Scientific) - Wire Contamination (2024)

Laceration Risk

Foreign material may be present on the enclosed section of the cutting wire which may lead to inability to optimally bow the sphincterotome. This issue may lead to prolongation of procedure.

FDAJun 12, 2024Nationwide• Boston Scientific Corporation

BIOFIRE FILMARRAY Pneumonia Panel (BioFire) - Control Failure (2024)

Pneumonia panels have an increased risk of control failures due to an issue in the manufacturing process, which could lead to delayed results for the customer.

FDAJun 10, 2024Nationwide• BioFire Diagnostics, LLC

Oatmeal Body Lotion (Brands International) – Mold Contamination (2024)

Microbial Contamination of Non-Sterile Products: confirmed presence of mold contamination

Class IIModerate

FDAJun 10, 2024Nationwide• Brands International Corporation

OMTech Desktop Laser Engraver (Rygel Advanced Machines) – Interlocks Missing (2024)

Lack of redundant interlocks, missing required labels and certification labels as required by 21 1010.2.

FDAJun 7, 2024Nationwide• Rygel Advanced Machines d/b/a Omtech Laser

RX Series Cystatin C Reagent (Randox) - 510k Compliance (2024)

Cystatin C Reagent marketed without a 510 (k)

FDAJun 7, 2024Nationwide• Randox Laboratories Ltd. 55 Diamond Road Crumlin (North) Ireland

Allopurinol Tablets (Dr. Reddy's) – Foreign Substance (2024)

Presence of foreign substance.

Class IIModerate

FDAJun 7, 2024IL, MS, OH• Dr. Reddy's Laboratories, Inc.

Wabash National Van (Wabash National) – Improper Base Rail Bonding (2024)

Wabash National Corporation (Wabash) is recalling certain 2024-2025 RFCVHSC refrigerated van trailers. The base rails may not be bonded properly and can detach, reducing the structural strength of the trailer.

NHTSAJun 5, 2024Nationwide• WABASH NATIONAL

Stellalife Vega Oral Spray (Homeocare) – Microbial Contamination (2024)

Microbial Contamination of Non-Sterile Products: multiple Bacillus species organisms

Class IHigh

FDAJun 5, 2024Nationwide• Homeocare Laboratories, Inc.

Stellalife Vega Oral Rinse (Homeocare) – Microbial Contamination (2024)

Microbial Contamination of Non-Sterile Products: presence of Terribacillus species organism

Class IIModerate

FDAJun 5, 2024Nationwide• Homeocare Laboratories, Inc.

Trulight 5000/3000 Surgical Light (Baxter) – Thermal Injury Risk (2024)

Baxter Healthcare Corporation is issuing an Urgent Medical Device Correction due to customer reports of thermal skin injuries when using the iLED 7 surgical light system products listed below. Specific VidiaPort and Trulight product codes are also impacted as they are equipped with iLED 7 light-heads

FDAJun 4, 2024Nationwide• Baxter Healthcare Corporation

Beckman Coulter DXL 9000 Analyzer (Beckman Coulter) – Cable Corrosion Risk (2024)

The analyzers were built with nonconforming USB cables made with brass contacts instead of specified gold contacts. Brass contacts may corrode over time, leading to loss of internal instrument communication and delayed patient results.

FDAJun 4, 2024Nationwide• Beckman Coulter, Inc.

VidiaPort Carrying Arm (Baxter) – Thermal Injury Risk (2024)

FDAJun 4, 2024Nationwide• Baxter Healthcare Corporation

iLED 7 Surgical Lights (Baxter) – Thermal Injury Risk (2024)

FDAJun 4, 2024Nationwide• Baxter Healthcare Corporation

Eszopiclone Tablets (Dr. Reddy's) – Impurity Specifications (2024)

Failed Impurities/Degradation Specifications: Related Substances

Class IIILow

FDAJun 4, 2024MS, OH• Dr. Reddy's Laboratories, Inc.