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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

47

Class I (Serious)

29

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 321–340 of 467 recalls

Lactated Ringer's Injection USP (Baxter) – Chemical Contamination (2012)

Chemical Contamination: The IV solutions were packaged in AVIVA containers which may contain trace levels of cumene hydroperoxide (CHP).

Class IIModerate

FDASep 21, 2012Nationwide• Baxter Healthcare Corp.

Dextrose/Sodium Chloride Injection (Baxter) – Chemical Contamination (2012)

Chemical Contamination: The IV solutions were packaged in AVIVA containers which may contain trace levels of cumene hydroperoxide (CHP).

Class IIModerate

FDASep 21, 2012Nationwide• Baxter Healthcare Corp.

10% Dextrose Injection USP (Baxter) – Chemical Contamination (2012)

Chemical Contamination: The IV solutions were packaged in AVIVA containers which may contain trace levels of cumene hydroperoxide (CHP).

1...15 161718 19...24

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Class IIModerate

FDASep 21, 2012Nationwide• Baxter Healthcare Corp.

Sodium Chloride Injection (Baxter) – Chemical Contamination (2012)

Chemical Contamination: The IV solutions were packaged in AVIVA containers which may contain trace levels of cumene hydroperoxide (CHP).

Class IIModerate

FDASep 21, 2012Nationwide• Baxter Healthcare Corp.

5% Dextrose Injection USP (Baxter) – Chemical Contamination (2012)

Chemical Contamination: The IV solutions were packaged in AVIVA containers which may contain trace levels of cumene hydroperoxide (CHP).

Class IIModerate

FDASep 21, 2012Nationwide• Baxter Healthcare Corp.

Baxter Healthcare Corp. Rt.: Buretrol Solution Sets, a sterile fluid pathway of 105 (2...

The tubing may separate from the distal Clearlink Y-site of the set, which could result in patient injury if the separation occurs during patient use.

FDANov 3, 2009Nationwide• Baxter Healthcare Corp. Rt.

Baxter Healthcare Corp.: Baxter's elastomeric infusion pumps are non-electronic, a...

There are reported incidents of leakage on the INFUSOR and FOLFUSOR pumps at the connection of the blue winged cap and the distal male Luer. Investigation of these reports indicates the incidence of leakage has only occurred after pumps are filled, primed, re-capped (using the blue winged Luer cap) and stored for a period of time, typically overnight. In addition, the reported instances of leakage

Class IIModerate

FDAJul 31, 2009Nationwide• Baxter Healthcare Corp.

Baxter Healthcare Corp.: Baxter's elastomeric infusion pumps are non-electronic, a...

There are reported incidents of leakage on the INFUSOR and FOLFUSOR pumps at the connection of the blue winged cap and the distal male Luer. Investigation of these reports indicates the incidence of leakage has only occurred after pumps are filled, primed, re-capped (using the blue winged Luer cap) and stored for a period of time, typically overnight. In addition, the reported instances of leakage

Class IIModerate

FDAJul 31, 2009Nationwide• Baxter Healthcare Corp.

Baxter Healthcare Corp.: Baxter's elastomeric infusion pumps are non-electronic, a...

There are reported incidents of leakage on the INFUSOR and FOLFUSOR pumps at the connection of the blue winged cap and the distal male Luer. Investigation of these reports indicates the incidence of leakage has only occurred after pumps are filled, primed, re-capped (using the blue winged Luer cap) and stored for a period of time, typically overnight. In addition, the reported instances of leakage

Class IIModerate

FDAJul 31, 2009Nationwide• Baxter Healthcare Corp.

Baxter Healthcare Corp.: Baxter's elastomeric infusion pumps are non-electronic, a...

There are reported incidents of leakage on the INFUSOR and FOLFUSOR pumps at the connection of the blue winged cap and the distal male Luer. Investigation of these reports indicates the incidence of leakage has only occurred after pumps are filled, primed, re-capped (using the blue winged Luer cap) and stored for a period of time, typically overnight. In addition, the reported instances of leakage

FDAJul 31, 2009Nationwide• Baxter Healthcare Corp.

Baxter Healthcare Corp. Rt.: Baxter Minicap Extended Life PD Transfer Set (6") with Tw...

The peritoneal dialysis transfer set has a defective white sleeve twist clamp. The twist clamp will not open or close completely, which could cause leakage and lead to peritonitis.

FDAJul 2, 2009AR, IL, MS +3 more• Baxter Healthcare Corp. Rt.

Baxter Healthcare Corp. Rt.: Baxter Colleague CX Infusion Pump, Single Channel Volumet...

There was no documentation to show the required tests were performed following the replacement of the battery and battery harness.

FDAMay 8, 2009PR• Baxter Healthcare Corp. Rt.

Baxter Healthcare Corp. Rt.: Baxter Colleague Single Channel Volumetric Infusion Pumps...

Baxter has identified failure codes that lead to an interruption of therapy, hazards associated with improper cleaning, and damaged battery messages for the Colleague Infusion Pumps.

FDAJan 23, 2009PR• Baxter Healthcare Corp. Rt.

Baxter Healthcare Corp. Rt.: Baxter Colleague Triple Channel Volumetric Infusion Pumps...

Baxter has identified failure codes that lead to a delay or an interruption of therapy, hazards associated with improper cleaning, and damaged battery messages for the Colleague Infusion Pumps.

FDAJan 23, 2009PR• Baxter Healthcare Corp. Rt.

Baxter Healthcare Corp. Rt.: Baxter Auto Syringe AS50 Infusion Pump, product code 1M85...

Non-conforming Electrostatic Discharge (ESD) grounding squares may cause the pump to be susceptible to shorting-out of circuitry, resulting in a loss of audio, and/or interruption of therapy.

FDASep 5, 2008PR• Baxter Healthcare Corp. Rt.

Baxter Healthcare Corp. Rt.: Logix TPN Software Solution, catalog 2M8410, consists of ...

Software anomaly results in inaccurate information being printed out on the Delivery Report, even though the compounder performed the compounding correctly.

FDAMar 28, 2008AZ, MN, WI +1 more• Baxter Healthcare Corp. Rt.

Baxter Healthcare Corp. Rt.: Baxter HEP LOCK (Heparin Lock Flush Solution, USP) 10 u/m...

Due to an increase of adverse events in Baxter single and multi-dose Heparin for injection products, which used the same active pharmaceutical ingredient (API) source as the HEP LOCK products

FDAFeb 28, 2008PR• Baxter Healthcare Corp. Rt.

Baxter Healthcare Corp. Rt.: Baxter HEP-LOCK (Preservative-Free Heparin Lock Flush Sol...

Due to an increase of adverse events in Baxter single and multi-dose Heparin for injection products, which used the same active pharmaceutical ingredient (API) source as the HEP LOCK products

FDAFeb 28, 2008PR• Baxter Healthcare Corp. Rt.

Baxter Healthcare Corp. Rt.: Baxter Single Day INFUSOR Portable Elastomeric Infusion S...

Leaking: leaks at the tubing flow restrictor connection to either the coupler or the male luer during filling.

FDANov 29, 2007Nationwide• Baxter Healthcare Corp. Rt.

Baxter Healthcare Corp. Rt.: Baxter Colleague CX Single Channel Volumetric Infusion Pu...

Some of the pumps were upgraded by one service technician who failed to replace prisms and batteries as required in the upgrade.

FDAAug 15, 2007CA, FL• Baxter Healthcare Corp. Rt.