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CareFusion 303 Recalls

173 recalls on record · August 1, 2012 to June 10, 2026 · Medical Devices

Recalls by year

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Count of recall notices naming this brand, by the year the recall was announced. A quiet year is not proof of a safe year.

March 19, 2025Medical DevicesFDA
CareFusion 303, Inc. recalls BD Alaris Systems Manager , REF 9601 Infusion Safety Management Software
Hazard: Software issue that may result in outdated automated programming request(APR) being sent to the progressive care unit (PCU).
March 5, 2025Medical DevicesFDA
CareFusion 303, Inc. recalls BD Alaris Pump Module REF 8100 The BD Alaris System with Guardrails Suite MX is a modular infusion pump and monitorin
Hazard: 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.
March 5, 2025Medical DevicesFDA
CareFusion 303, Inc. recalls 139088-01 BD PYXIS MEDBANK MEDPASS MODULE 169-151 BD PYXIS MEDBANK MINI 1FH-2HH MEDPASS 169-152 BD PYXIS MEDBANK MINI 2H
Hazard: Labeling update to include a contraindication statement against the use of medicine cabinets in procedure and operating rooms.
March 5, 2025Medical DevicesFDA
CareFusion 303, Inc. recalls 139054-01 BD PYXIS MEDFLEX MN 1000 10HH-1FM 139055-01 BD PYXIS MEDFLEX MN 1000 12HH 139053-01 BD PYXIS MEDFLEX MN 1000 2
Hazard: Labeling update to include a contraindication statement against the use of medicine cabinets in procedure and operating rooms.
March 5, 2025Medical DevicesFDA
CareFusion 303, Inc. recalls 155288-01 BD PYXIS MEDBANK MINI 1FH-1FM 169-137 BD PYXIS MEDBANK MINI 1FH-1FM 155311-01 BD PYXIS MEDBANK MINI 1FH-2HH 13
Hazard: Labeling update to include a contraindication statement against the use of medicine cabinets in procedure and operating rooms.
March 5, 2025Medical DevicesFDA
CareFusion 303, Inc. recalls 138913-01 BD PYXIS MEDBANK MINI CR-2HH-1FH-P 169-114 BD PYXIS MEDBANK MINI CR-2HH-1FH-P 138911-01 BD PYXIS MEDBANK MINI
Hazard: Labeling update to include a contraindication statement against the use of medicine cabinets in procedure and operating rooms.
March 5, 2025Medical DevicesFDA
CareFusion 303, Inc. recalls BD Pyxis MedFlex 2.0 REF 1139-00 Bio-ID Spare Parts REF 353200-01 The BD Pyxis" MedFlex is an Automated Dispensing
Hazard: Due to fingerprint scanner failing resulting in the scanner heating up.
March 5, 2025Medical DevicesFDA
CareFusion 303, Inc. recalls BD Pyxis: MedFlex, REF: 1119-00; MedBank Tower REF: 1145-00; MedBank MedPass, REF: 139088-01 and associated BD Pyxis use
Hazard: 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.
February 19, 2025Medical DevicesFDA
CareFusion 303, Inc. recalls BD Pyxis MedStation 4000 REF: 303. Intended to securely store and dispense medications to a qualified and authorized he
Hazard: Retroactive-Due to increase in complaints, their is a potential for drawer and/or door failures of the medication cabinet which could result in delay in accessing medications.
February 19, 2025Medical DevicesFDA
CareFusion 303, Inc. recalls BD Pyxis MedStation Auxiliary 4000 REF: 306. Intended to securely store and dispense medications to a qualified and aut
Hazard: Retroactive-Due to increase in complaints, their is a potential for drawer and/or door failures of the medication cabinet which could result in delay in accessing medications.
February 19, 2025Medical DevicesFDA
CareFusion 303, Inc. recalls BD Pyxis MedStation Auxiliary ES REF: 324. Intended to securely store and dispense medications to a qualified and autho
Hazard: Retroactive-Due to increase in complaints, their is a potential for drawer and/or door failures of the medication cabinet which could result in delay in accessing medications.
February 19, 2025Medical DevicesFDA
CareFusion 303, Inc. recalls BD Pyxis MedStation ES (Med ES Main) REF: 323. Intended to securely store and dispense medications to a qualified and
Hazard: Retroactive-Due to increase in complaints, their is a potential for drawer and/or door failures of the medication cabinet which could result in delay in accessing medications.
February 19, 2025Medical DevicesFDA
CareFusion 303, Inc. recalls (1) BD Pyxis MedStation ES, Catalog No. 323; (2) BD Pyxis Anesthesia Station (PAS), Catalog No. 327; (3) BD Pyxis MedSta
Hazard: Labeling is insufficient regarding delays in access to medication. The firm is strengthening the label as an additional risk mitigation.
February 19, 2025Medical DevicesFDA
CareFusion 303, Inc. recalls (1) Pyxis MedStation ES, Catalog No. 323; (2) Pyxis Anesthesia Station (PAS), Catalog No. 327; (3) Pyxis MedStation ES
Hazard: 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
February 5, 2025Medical DevicesFDA
CareFusion 303, Inc. recalls BD Pyxis MedStation ES AUX Tower REF 343 BD Pyxis " MedStation 4000 AUX Tower REF 314 The BD Pyxis" MedStation ES
Hazard: Due to an increase in complaints of door latch assembly failures that may cause the doors to be left in an open state potentially causing inventory discrepancies, a delay in access to medication and/or diversion of medication.
January 29, 2025Medical DevicesFDA
CareFusion 303, Inc. recalls BD Pyxis Med 4000 Auxiliary (AUX), REF 314
Hazard: Drawer and/or door failures that may lead to a delay in access to medications. The following three situations in which drawer and/or door failures may occur have been identified: Situation 1: Door Latch Failure, Situation 2: Cable Ribbon Damage, Situation 3: Magnet Falling Out,
January 29, 2025Medical DevicesFDA
CareFusion 303, Inc. recalls BD Pyxis Med ES Auxiliary (AUX), REF 343
Hazard: Drawer and/or door failures that may lead to a delay in access to medications. The following three situations in which drawer and/or door failures may occur have been identified: Situation 1: Door Latch Failure, Situation 2: Cable Ribbon Damage, Situation 3: Magnet Falling Out,
January 29, 2025Medical DevicesFDA
CareFusion 303, Inc. recalls BD Pyxis MedStation 4000 AUX, REF 306
Hazard: Drawer and/or door failures that may lead to a delay in access to medications. The following three situations in which drawer and/or door failures may occur have been identified: Situation 1: Door Latch Failure, Situation 2: Cable Ribbon Damage, Situation 3: Magnet Falling Out,
January 29, 2025Medical DevicesFDA
CareFusion 303, Inc. recalls BD Pyxis MedStation 4000 Main, REF 303
Hazard: Drawer and/or door failures that may lead to a delay in access to medications. The following three situations in which drawer and/or door failures may occur have been identified: Situation 1: Door Latch Failure, Situation 2: Cable Ribbon Damage, Situation 3: Magnet Falling Out,
January 29, 2025Medical DevicesFDA
CareFusion 303, Inc. recalls BD Pyxis MedStation ES AUX, REF 324
Hazard: Drawer and/or door failures that may lead to a delay in access to medications. The following three situations in which drawer and/or door failures may occur have been identified: Situation 1: Door Latch Failure, Situation 2: Cable Ribbon Damage, Situation 3: Magnet Falling Out,
January 29, 2025Medical DevicesFDA
CareFusion 303, Inc. recalls BD Pyxis MedStation ES (Med ES Main), REF 323
Hazard: Drawer and/or door failures that may lead to a delay in access to medications. The following three situations in which drawer and/or door failures may occur have been identified: Situation 1: Door Latch Failure, Situation 2: Cable Ribbon Damage, Situation 3: Magnet Falling Out,
January 22, 2025Medical DevicesFDA
CareFusion 303, Inc. recalls BD Pyxis MedStation ES (Med ES Main), REF: 323; and BD Pyxis MedStation ES (Med ES Main Tower), REF: 352
Hazard: Due to an automated dispensing cabinet software issue, when a medication single order contains more than one component and at least one is unavailable for a multi-item or combination order, the order may display as grayed out; alternate location tooltip will display "Server connection failed," not listing other area devices where unavailable item(s) may be found, which may lead to delayed therapy.
December 18, 2024Medical DevicesFDA
CareFusion 303, Inc. recalls BD Pyxis CII Safe ES, REF: 1116-00
Hazard: 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.
December 18, 2024Medical DevicesFDA
CareFusion 303, Inc. recalls BD Pyxis MedStation ES 7 Drawer Auxiliary Tower, REF: 324
Hazard: 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.
December 18, 2024Medical DevicesFDA
CareFusion 303, Inc. recalls BD Pyxis MedStation ES, REF: 323
Hazard: 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.
September 25, 2024Medical DevicesFDA
CareFusion 303, Inc. recalls Alaris Pump Module Model 8100, a modular infusion pump and monitoring system
Hazard: 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.
September 25, 2024Medical DevicesFDA
CareFusion 303, Inc. recalls Alaris Syringe Module Model 8110, a modular infusion pump and monitoring system
Hazard: 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.
September 25, 2024Medical DevicesFDA
CareFusion 303, Inc. recalls Alaris EtCO2 Module Model 8300, a modular infusion pump and monitoring system
Hazard: 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.
September 25, 2024Medical DevicesFDA
CareFusion 303, Inc. recalls Alaris PCA Module Model 8120, a modular infusion pump and monitoring system
Hazard: 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.
September 25, 2024Medical DevicesFDA
CareFusion 303, Inc. recalls Alaris System PC Unit Model 8015 - a modular infusion pump and monitoring system
Hazard: 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.