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Baxter Healthcare Corp.

Baxter Healthcare Corp. Recalls

All product recalls associated with Baxter Healthcare Corp..

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Recall Summary

Total Recalls

467

Past Year

Class I (Serious)

Most Recent

Oct 2025

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 281–300 of 467 recalls

Fluconazole Injection (Baxter) – Seal Leak Risk (2014)

Lack of Assurance of Sterility: Complaints of leaks due to an incomplete seal at the bag seam.

Class IIModerate

FDADec 23, 2014Nationwide• Baxter Healthcare Corp.

Baxter Healthcare Corp.: Baxter Integrated APD Set with Cassette 3-Prong, Sterile,...

Baxter is issuing a recall for one lot of Integrated Automated Peritoneal Dialysis set with Cassette 3 prong due to complaints received for leakage.

Class IIModerate

FDADec 8, 2014Nationwide• Baxter Healthcare Corp.

Sodium Chloride Injection (Baxter) - Plastic Contamination (2014)

Presence of Particulate Matter: Confirmed customer complaints received for the presence of blue plastic, identified as fragments of the frangible from the vial adapter.

1...13 141516 17...24

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Class IHigh

FDADec 4, 2014Nationwide• Baxter Healthcare Corp

Clinimix E Solution (Baxter) – Sterility Concerns (2014)

Lack of Assurance of Sterility; leaks were observed from the bag seam and port seal

Class IIModerate

FDANov 25, 2014Nationwide• Baxter Healthcare Corp.

Potassium Chloride Injection (Baxter) – Incorrect Label (2014)

Labeling: Label Error On Declared Strength: Bags of Potassium Chloride 10 mEq per 100 mL were incorrectly overpouched with wraps labeled as Potassium Chloride Injection, 20 mEq per 100 mL.

Class IIModerate

FDANov 10, 2014Nationwide• Baxter Healthcare Corp.

Heparin Sodium Injection (Baxter Healthcare) – low potency (2014)

Subpotent Drug: Heparin raw material was found to have low potency

Class IIModerate

FDAOct 30, 2014Nationwide• Baxter Healthcare Corp.

Baxter Healthcare Corp.: HomeChoice/HomeChoice Pro Automated Personal Cycler, for ...

The keypad buttons on HomeChoice devices may be activated without the operator pressing them.

Class IIModerate

FDAOct 21, 2014AL, AZ, AR +33 more• Baxter Healthcare Corp.

Baxter Healthcare Corp.: HomeChoice Automated PD system and HomeChoice Pro Automat...

There are additional and updated warning and cautions that are not in the Patient At-Home Guide for HomeChoice Automated PD Systems and HomeChoice PRO Automated PD Systems.

Class IIModerate

FDAOct 6, 2014Nationwide• Baxter Healthcare Corp.

DOPamine Hydrochloride Injection (Baxter) – Sterility Risk (2014)

Laceration Risk

Lack of Assurance of Sterility: A small cut in the solution bag may have been introduced during the manufacturing process, resulting in a leak of the bag into the overpouch.

Class IIModerate

FDASep 29, 2014Nationwide• Baxter Healthcare Corp.

Baxter Healthcare Corp: Baxter 2B8011 Empty INTRA VIA Container with PVC Ports, ...

Particulate matter found inside the fluid path.

Class IHigh

FDASep 16, 2014Nationwide• Baxter Healthcare Corp

Baxter Healthcare Corp: Baxter 2B8013 Empty INTRA VIA Container with PVC Ports (...

Particulate matter found inside the fluid path.

Class IHigh

FDASep 16, 2014Nationwide• Baxter Healthcare Corp

Potassium Chloride Injection (Baxter) – Product Mispack (2014)

Correct Labeled Product Mispack: Shipping cartons labeled as containing Potassium Chloride injection actually contained bags labeled and containing Gentamicin Sulfate injection inside.

Class IIModerate

FDASep 8, 2014Nationwide• Baxter Healthcare Corp

Baxter Healthcare Corp.: SPECTRUM Pump, Model No. 35700BAX. Intended to be use...

One Service Technician may not have correctly serviced specific Sigma Spectrum Infusion Pumps according to established procedures during the time period of 5/5/2014 through 6/3/2014.

Class IIModerate

FDASep 3, 2014Nationwide• Baxter Healthcare Corp.

Dianeal Low Calcium Dialysis Solution (Baxter) – Particulate Contamination (2014)

Presence of Particulate Matter: particulate matter was found during the manufacturing process.

Class IHigh

FDAAug 7, 2014Nationwide• Baxter Healthcare Corp.

ProSol Amino Acid Injection (Baxter) – Particulate Contamination (2014)

Presence of Particulate Matter: identification of particulates in a retention sample that have been identified as a mixture of the amino acid leucine and inorganic material (containing iron, silicone and chlorine).

Class IIModerate

FDAAug 4, 2014Nationwide• Baxter Healthcare Corp

Sodium Chloride Injection (Baxter) – mold contamination (2014)

Lack of Assurance of Sterility; complaints of mold in the overpouch

Class IIModerate

FDAJul 30, 2014Nationwide• Baxter Healthcare Corp.

Baxter Healthcare Corp: BaxterBuretrol Solution Set105" (2.7 m)150 mL...

Baxter Healthcare Corporation is voluntarily issuing a recall for specific lots of Buretrol Solution set product codes due to complaints for separation between the burette chamber and the drip chamber. Affected product codes are: 2C7564, 2C8864 and 2H8864.

Class IIModerate

FDAJul 14, 2014Nationwide• Baxter Healthcare Corp

Potassium Chloride Injection (Baxter) – Particulate Contamination (2014)

Presence of Particulate Matter: particulate matter identified as fibers and/or plastics

Class IHigh

FDAJul 11, 2014Nationwide• Baxter Healthcare Corp.

Sodium Chloride Injection (Baxter) – Particulate Contamination (2014)

Presence of Particulate Matter: particulate matter identified as fibers and/or plastics.

Class IHigh

FDAJul 11, 2014Nationwide• Baxter Healthcare Corp.

Sodium Chloride Injection (Baxter) – Particulate Contamination (2014)

Presence of Particulate Matter: particulate matter identified as fibers and/or plastics.

Class IHigh

FDAJul 11, 2014Nationwide• Baxter Healthcare Corp.

Stay Informed

Baxter Healthcare Corp. Recalls

Recall Summary

Fluconazole Injection (Baxter) – Seal Leak Risk (2014)

Baxter Healthcare Corp.: Baxter Integrated APD Set with Cassette 3-Prong, Sterile,...

Sodium Chloride Injection (Baxter) - Plastic Contamination (2014)

Clinimix E Solution (Baxter) – Sterility Concerns (2014)

Potassium Chloride Injection (Baxter) – Incorrect Label (2014)

Heparin Sodium Injection (Baxter Healthcare) – low potency (2014)

Baxter Healthcare Corp.: HomeChoice/HomeChoice Pro Automated Personal Cycler, for ...

Baxter Healthcare Corp.: HomeChoice Automated PD system and HomeChoice Pro Automat...

DOPamine Hydrochloride Injection (Baxter) – Sterility Risk (2014)

Baxter Healthcare Corp: Baxter 2B8011 Empty INTRA VIA Container with PVC Ports, ...

Baxter Healthcare Corp: Baxter 2B8013 Empty INTRA VIA Container with PVC Ports (...

Potassium Chloride Injection (Baxter) – Product Mispack (2014)

Baxter Healthcare Corp.: SPECTRUM Pump, Model No. 35700BAX. Intended to be use...

Dianeal Low Calcium Dialysis Solution (Baxter) – Particulate Contamination (2014)

ProSol Amino Acid Injection (Baxter) – Particulate Contamination (2014)

Sodium Chloride Injection (Baxter) – mold contamination (2014)

Baxter Healthcare Corp: ***Baxter***Buretrol Solution Set***105" (2.7 m)***150 mL...

Potassium Chloride Injection (Baxter) – Particulate Contamination (2014)

Sodium Chloride Injection (Baxter) – Particulate Contamination (2014)

Sodium Chloride Injection (Baxter) – Particulate Contamination (2014)

Baxter Healthcare Corp: BaxterBuretrol Solution Set105" (2.7 m)150 mL...