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CareFusion 303, Inc.

CareFusion 303, Inc. Recalls

All product recalls associated with CareFusion 303, Inc..

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Recall Summary

Total Recalls

197

Past Year

Class I (Serious)

Most Recent

Dec 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 141–160 of 197 recalls

CareFusion 303, Inc.: BD Alaris System. The EtCO2 module is a capnograph indica...

Infusion pump component defect may result in interruption of patient monitoring

FDAAug 4, 2020Nationwide• CareFusion 303, Inc.

CareFusion 303, Inc.: BD Alaris System PC Unit Model 8100 (Pump Module) and Pum...

Pump Module keypad may exhibit keys that are unresponsive or stuck as a result of fluid ingress potentially resulting in a delay to the start of infusion or interruption of infusion. Delays in an infusion or interruption can cause serious injury or death in high-risk patient populations.

FDAAug 4, 2020AL, AK, AZ +49 more• CareFusion 303, Inc.

ChloraPrep With Tint (CareFusion) – Product Contamination (2020)

Microbial Contamination of Non-Sterile Products:Product is being recalled to climatic Zone IV regions of the world where at the labeled storage conditions of 30*C/75% Relative Humidity for more than 6 months, there is the potential for growth of Aspergillus penicillioides, a type of fungus, resulting in a breach of the package integrity.

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Class IHigh

FDAJul 7, 2020IN, PR• CareFusion 213, LLC

BD ChloraPrep Clear (CareFusion) – Non-Sterility Risk (2020)

Non-sterility: Product is being recalled to climatic Zone IV regions of the world where at the labeled storage conditions of 30*C/75% Relative Humidity for more than 6 months, there is the potential for growth of Aspergillus penicillioides, a type of fungus, resulting in a breach of the package integrity.

Class IHigh

FDAJul 7, 2020IN, PR• CareFusion 213, LLC

BD ChloraPrep Hi-Lite Orange (CareFusion) – Non-Sterility Risk (2020)

Class IHigh

FDAJul 7, 2020IN, PR• CareFusion 213, LLC

ChloraPrep One-Step (CareFusion) – Microbial Contamination (2020)

Microbial Contamination of Non-Sterile Product: Product is being recalled to climatic Zone IV regions of the world where at the labeled storage conditions of 30*C/75% Relative Humidity for more than 6 months, there is the potential for growth of Aspergillus penicillioides, a type of fungus, resulting in a breach of the package integrity.

Class IHigh

FDAJul 7, 2020IN, PR• CareFusion 213, LLC

CareFusion 303, Inc.: Alaris Auto ID Module Model 8600, a modular infusion pump...

Cleaning agents may damage Inter-Unit Interface (IUI) Connectors, which may lead to interruption of communication or power between PC Unit and modules, which may result in an infusion that stops with a CHANNEL DISCONNECTED message, and an audio/visual alarm on the PC Unit and an interruption of therapy or monitoring.

FDAJun 30, 2020Nationwide• CareFusion 303, Inc.

CareFusion 303, Inc.: Alaris Syringe Module Model 8110 - Product Usage: is inte...

LED display, which provides infusion or patient monitoring values, on the module may have segments that appear dim.

FDAJun 30, 2020Nationwide• CareFusion 303, Inc.

CareFusion 303, Inc.: Alaris Syringe Module Model 8110, a modular infusion pump...

FDAJun 30, 2020Nationwide• CareFusion 303, Inc.

CareFusion 303, Inc.: Alaris SpO2 Module Model 8210 and Model 8220, a modular i...

FDAJun 30, 2020Nationwide• CareFusion 303, Inc.

CareFusion 303, Inc.: Alaris EtCO2 Module Model 8300 - Product Usage: is intend...

LED display, which provides infusion or patient monitoring values, on the module may have segments that appear dim.

FDAJun 30, 2020Nationwide• CareFusion 303, Inc.

CareFusion 303, Inc.: Alaris SpO2 Module Model 8210 and Model 8220 - Product Us...

LED display, which provides infusion or patient monitoring values, on the module may have segments that appear dim.

FDAJun 30, 2020Nationwide• CareFusion 303, Inc.

CareFusion 303, Inc.: Alaris EtCO2 Module Model 8300, a modular infusion pump a...

FDAJun 30, 2020Nationwide• CareFusion 303, Inc.

CareFusion 303, Inc.: Alaris System PC Unit Model 8000, a modular infusion pump...

FDAJun 30, 2020Nationwide• CareFusion 303, Inc.

CareFusion 303, Inc.: Alaris Pump Module Model 8100 - Product Usage: is intende...

LED display, which provides infusion or patient monitoring values, on the module may have segments that appear dim.

FDAJun 30, 2020Nationwide• CareFusion 303, Inc.

CareFusion 303, Inc.: Alaris Pump Module Model 8100

Broken elements on pump module platen such as broken upper hinge post, lower hinge, and membrane frame can occur when the door is forcefully closed on an object, the device is dropped, or if improper cleaners are used on the membrane frame assembly. These may prevent devices from delivering accurate amounts of fluid, which may result in an over infusion, free-flow conditions, or under infusion.

FDAJun 30, 2020AL, AK, AZ +48 more• CareFusion 303, Inc.

CareFusion 303, Inc.: Alaris PCA Module Model 8120, a modular infusion pump and...

FDAJun 30, 2020Nationwide• CareFusion 303, Inc.

CareFusion 303, Inc.: Alaris PCA Module Model 8120 - Product Usage: is intended...

LED display, which provides infusion or patient monitoring values, on the module may have segments that appear dim.

FDAJun 30, 2020Nationwide• CareFusion 303, Inc.

CareFusion 303, Inc.: Alaris System PC Unit Model 8000 modular infusion pump an...

If one or more screws or washers are loose or missing causing the battery not to be properly secured to the PC Unit, that is running on battery power, the system may experience a power loss with a prolonged, non-silenceable alarm. Power loss may result in an interruption of patient therapy or monitoring.

FDAJun 30, 2020AL, AK, AZ +49 more• CareFusion 303, Inc.

CareFusion 303, Inc.: Alaris Pump Module Model 8100, a modular infusion pump an...

FDAJun 30, 2020Nationwide• CareFusion 303, Inc.