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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

631

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 161–180 of 10391 recalls

CLEARLINK Paclitaxel Set (Baxter) – IV Set Leak (2025)

IV sets may leak.

Low

FDAAug 29, 2025Nationwide• Baxter Healthcare Corporation

CLEARLINK Extension Set (Baxter) – IV Set Leak (2025)

IV sets may leak.

Low

FDAAug 29, 2025Nationwide• Baxter Healthcare Corporation

CLEARLINK Extension Set (Baxter) – Potential Leakage (2025)

IV sets may leak.

Low

FDAAug 29, 2025Nationwide• Baxter Healthcare Corporation

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CLEARLINK NON-DEHP Solution Set (Baxter) – IV Set Leak (2025)

IV sets may leak.

Low

FDAAug 29, 2025Nationwide• Baxter Healthcare Corporation

CLEARLINK System Solution Set (Baxter) – IV Set Leak (2025)

IV sets may leak.

Low

FDAAug 29, 2025Nationwide• Baxter Healthcare Corporation

Sharesource Connectivity Platform (Vantive) – Software Prescription Error (2025)

Vantive has identified a software defect within the Sharesource Claria software, which may cause a patient s updated prescription program settings to not be properly saved on the actual cycler that the patient is using to perform their therapy. As a result, the clinician may think that the patient is receiving the correct prescribed therapy because of what is erroneously displayed on the clinician's remote Sharesource application, when in fact the cycler that is with the patient is actually delivering an outdated and incorrect therapy.

High

FDAAug 28, 2025Nationwide• Vantive US Healthcare LLC

12-Drawer Dressers (Lulive) – tip-over risk (2025)

This recall involves Lulive 12-drawer dressers. The recalled dressers were sold in white and have a metal frame and wooden top, 12 collapsing fabric drawers of different sizes with handles, four side-pockets, and two hooks. The dressers measure about 12 inches by 39 inches by 45 inches and weigh 30 pounds. "KF-X9Y1" is printed on the product packaging.

Very High

CPSCAug 28, 2025Nationwide• Changzhou Hengze Home Furnishing Co., of China

Chlorpromazine Tablets (Amerisource) – Foreign Substance Detected (2025)

Presence of a foreign substance.A specific lot of auxiliary polyester coil, used in product packaging at the manufacturing site, was detected with presence of a micro-organism. No micro-organism was detected on any tablets.

Class IIModerate

FDAAug 27, 2025Nationwide• Amerisource Health Services LLC

Cyclobenzaprine Tablets (Unichem) – Labeling Mix-Up (2025)

Labeling: Label Mix Up; Bottles of Meloxicam USP, 7.5mg, 90-count tablets (yellow in color), were labeled as Cyclobenzaprine Hydrochloride Tablets USP, 10 mg 90-count tablets (blue in color).

Class IHigh

FDAAug 27, 2025Nationwide• Unichem Pharmaceuticals USA Inc.

Osstem Dental X-Ray System (Osstem) – Labeling Issue (2025)

Osstem Implant Co. Ltd, is voluntarily initiating a medical device correction involving the current labeling for this electronic product may be missing a required Certification Statement under 21 CFR Subchapter J (Radiological Health Regulations). Specifically, the following statement may have been omitted: Certification Statement: This electronic product complies with all applicable performance standards prescribed under 21 CFR Subchapter J, as enforced by the U.S. Food and Drug Administration at the date of manufacturing.

Low

FDAAug 26, 2025Nationwide• OSSTEM Implant Co., Ltd. 66-16 Bansong-Ro 513beon-Gil Busan City Haeundae District Korea (the Republic of)

Acetaminophen Injection (Baxter Healthcare) - Discoloration (2025)

Discoloration

Class IIModerate

FDAAug 20, 2025Nationwide• Baxter Healthcare Corporation

Sulfamethoxazole Trimethoprim Tablets (Northwind Pharmaceuticals) - Foreign Substance (2025)

Presence of a Foreign Substance: A specific lot of auxiliary polyester coil, used in product packaging by manufacturer (Amneal Pharmaceuticals LLC) was detected with presence of a micro-organism. No micro-organism was detected on any tablets.

Class IIModerate

FDAAug 20, 2025Nationwide• Northwind Pharmaceuticals LLC

Carvedilol Tablets (Harvard Drug Group) - Impurity Concern (2025)

CGMP Deviations: Results for N-Nitroso Carvedilol Impurity-1 (NNCI) impurity observed to be above the FDA-recommended limit of NMT 4.0 ppm

Class IIModerate

FDAAug 20, 2025Nationwide• The Harvard Drug Group LLC dba Major Pharmaceuticals and Rugby Laboratories

Green Mint Chip Ice Cream (Hershey Creamery) – elevated coliform (2025)

Product tested elevated coliform counts during routine testing

Class IIModerate

FDAAug 19, 2025DE, FL, IN +4 more• HERSHEY CREAMERY CO.

CorNeat EverPatch (CorNeat Vision) – Surgical Patch Exposure (2025)

Reviewed complaints have identified that conjunctival wound dehiscence may result in early exposure of the surgical patch.

FDAAug 18, 2025Nationwide• CORNEAT VISION, LTD. 4, Ha-Sheizaf Ra'Anana Israel

EverPatch+ (CorNeat Vision) – Surgical Patch Exposure (2025)

Reviewed complaints have identified that conjunctival wound dehiscence may result in early exposure of the surgical patch.

FDAAug 18, 2025Nationwide• CORNEAT VISION, LTD. 4, Ha-Sheizaf Ra'Anana Israel

Philips CT System (Philips) – Patient Table Descent Risk (2025)

The patient support table (couch) may descend unexpectedly to the lowermost position due to a component (ball screw) misalignment after a replacement.

FDAAug 13, 2025Nationwide• Philips North America Llc

Stay Informed

Baxter Healthcare Corporation Recalls

Recall Summary

CLEARLINK Paclitaxel Set (Baxter) – IV Set Leak (2025)

CLEARLINK Extension Set (Baxter) – IV Set Leak (2025)

CLEARLINK Extension Set (Baxter) – Potential Leakage (2025)

CLEARLINK NON-DEHP Solution Set (Baxter) – IV Set Leak (2025)

CLEARLINK System Solution Set (Baxter) – IV Set Leak (2025)

Sharesource Connectivity Platform (Vantive) – Software Prescription Error (2025)

12-Drawer Dressers (Lulive) – tip-over risk (2025)

Chlorpromazine Tablets (Amerisource) – Foreign Substance Detected (2025)

Chlorpromazine Tablets (Amerisource) – Foreign Substance Detected (2025)

Chlorpromazine Tablets (Amerisource) – Foreign substance packaging (2025)

Chlorpromazine Tablets (Amerisource) – Foreign substance packaging (2025)

Cyclobenzaprine Tablets (Unichem) – Labeling Mix-Up (2025)

Osstem Dental X-Ray System (Osstem) – Labeling Issue (2025)

Acetaminophen Injection (Baxter Healthcare) - Discoloration (2025)

Sulfamethoxazole Trimethoprim Tablets (Northwind Pharmaceuticals) - Foreign Substance (2025)

Carvedilol Tablets (Harvard Drug Group) - Impurity Concern (2025)

Green Mint Chip Ice Cream (Hershey Creamery) – elevated coliform (2025)

CorNeat EverPatch (CorNeat Vision) – Surgical Patch Exposure (2025)

EverPatch+ (CorNeat Vision) – Surgical Patch Exposure (2025)

Philips CT System (Philips) – Patient Table Descent Risk (2025)