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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

96

Past Year

21

Class I (Serious)

0

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 21–40 of 96 recalls

BD Alaris Pump Module (CareFusion) – safety clamp error (2025)

Due to User Manual/Direction for Use incorrectly instructing user to leave the safety clamp in the open position when reloading an infusion set. This issue potentially could result in an accidental over infusion if the roller clamp is left open.

FDAJan 23, 2025AL, AK, AZ +47 more• CareFusion 303, Inc.

BD Pyxis (CareFusion) – Medication Access Label (2025)

Automated dispensing device labeling is being updated to strengthen labeling around manual access to medications to address the risk of potential delays in retrieving contents/ accessing medications that may result from power loss or potential automated dispensing device malfunctions.

FDAJan 10, 2025Nationwide• CareFusion 303, Inc.

Pyxis MedStation (CareFusion) – Software Risks (2025)

Software issues could potentially result in: 1) delays in accessing dispensing software application, 2) wrong therapy (dose, item, timing, etc.), or 3) unauthorized access and/or compliance related issues

Page 2 of 5Next

Moderate

FDAJan 8, 2025Nationwide• CareFusion 303, Inc.

BD Pyxis MedBank (CareFusion) – Labeling Update (2025)

Labeling update to include a contraindication statement against the use of medicine cabinets in procedure and operating rooms.

FDAJan 8, 2025Nationwide• CareFusion 303, Inc.

BD Pyxis MedFlex (CareFusion) – Labeling Update (2025)

Labeling update to include a contraindication statement against the use of medicine cabinets in procedure and operating rooms.

FDAJan 8, 2025Nationwide• CareFusion 303, Inc.

BD Pyxis MedBank (CareFusion) – Labeling Update (2025)

Labeling update to include a contraindication statement against the use of medicine cabinets in procedure and operating rooms.

FDAJan 8, 2025Nationwide• CareFusion 303, Inc.

BD Pyxis MedBank (CareFusion) – Labeling Update (2025)

Labeling update to include a contraindication statement against the use of medicine cabinets in procedure and operating rooms.

FDAJan 8, 2025Nationwide• CareFusion 303, Inc.

BD Pyxis (CareFusion) – Medication Access Label (2025)

Labeling is insufficient regarding delays in access to medication. The firm is strengthening the label as an additional risk mitigation.

FDAJan 8, 2025Nationwide• CareFusion 303, Inc.

BD Pyxis CII Safe ES (CareFusion) – Wrong Cubie Pocket (2024)

Due to a software issue, automated dispensing cabinet devices may open the wrong cubie pocket or position, which can lead to: 1) Unintended and incorrect medication removal, or 2) Potential for a different medication (medication pulled in error) to be refilled/loaded, which may lead to may lead to low inventory or a stockout.

FDANov 14, 2024Nationwide• CareFusion 303, Inc.

BD Pyxis MedStation Auxiliary Tower (CareFusion) – Wrong Cubie Pocket (2024)

Due to a software issue, automated dispensing cabinet devices may open the wrong cubie pocket or position, which can lead to: 1) Unintended and incorrect medication removal, or 2) Potential for a different medication (medication pulled in error) to be refilled/loaded, which may lead to may lead to low inventory or a stockout.

FDANov 14, 2024Nationwide• CareFusion 303, Inc.

BD Pyxis MedStation ES (CareFusion) – Wrong Cubie Pocket (2024)

Due to a software issue, automated dispensing cabinet devices may open the wrong cubie pocket or position, which can lead to: 1) Unintended and incorrect medication removal, or 2) Potential for a different medication (medication pulled in error) to be refilled/loaded, which may lead to may lead to low inventory or a stockout.

FDANov 14, 2024Nationwide• CareFusion 303, Inc.

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

Due to affected devices that may have bent female IUI connector and may not be operable and potentially cause delays in the start of the infusion or monitoring.

FDAAug 15, 2024Nationwide• CareFusion 303, Inc.

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

Due to affected devices that may have bent female IUI connector and may not be operable and potentially cause delays in the start of the infusion or monitoring.

FDAAug 15, 2024Nationwide• CareFusion 303, Inc.

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

Due to affected devices that may have bent female IUI connector and may not be operable and potentially cause delays in the start of the infusion or monitoring.

FDAAug 15, 2024Nationwide• CareFusion 303, Inc.

CareFusion 303, Inc.: Alaris System PC Unit Model 8015 - a modular infusion pum...

Due to affected devices that may have bent female IUI connector and may not be operable and potentially cause delays in the start of the infusion or monitoring.

FDAAug 15, 2024Nationwide• CareFusion 303, Inc.

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

Due to affected devices that may have bent female IUI connector and may not be operable and potentially cause delays in the start of the infusion or monitoring.

FDAAug 15, 2024Nationwide• CareFusion 303, Inc.

CareFusion 303, Inc.: BKIT BD Pyxis QFill Replenishment Station, REF: 155197-01...

Due to software issue, there is a potential when a restock label is printed for a medication stored in a non-CUBIE location, that the incorrect bin for the medication is printed on the label.

FDAJul 9, 2024Nationwide• CareFusion 303, Inc.

CareFusion 303, Inc.: BD Pyxis QFill Replenishment Station, REF: 138904-01, med...

Due to software issue, there is a potential when a restock label is printed for a medication stored in a non-CUBIE location, that the incorrect bin for the medication is printed on the label.

FDAJul 9, 2024Nationwide• CareFusion 303, Inc.

CareFusion 303, Inc.: BD PYXIS MEDBANK MINI CR-2HH-1FH-P, REF: 169-114 containi...

Due to software issue, there is a potential when a restock label is printed for a medication stored in automated dispensing cabinets, that the incorrect bin for the medication is printed on the label.

FDAJun 24, 2024Nationwide• CareFusion 303, Inc.

CareFusion 303, Inc.: BD PYXIS MEDBANK TWR MN CR-10HH-2FH-P, REF: 169-82 contai...

Due to software issue, there is a potential when a restock label is printed for a medication stored in automated dispensing cabinets, that the incorrect bin for the medication is printed on the label.

FDAJun 24, 2024Nationwide• CareFusion 303, Inc.