CareFusion 303, Inc.

65 FDA enforcement actions

65 Total Recalls

6 Class I

58 Class II

1 Class III

Firm Details

Product Types: device
States: CA

All Recalls

Class II: Risk 12/03/2025 device

Due a software issue that may result in equipment not receiving timely updates of patient, medication, or related information from enterprise systems.
Class II: Risk 11/20/2025 device

Automated Dispensing Cabinets (ADC) received a Half Height CUBIE drawer firmware update, which caused a Cubie Insert event which prompts software to generate a duplicate address, which causes an error and the drawer to fail, which may lead to inability or delay in accessing stored items, delay in the replenishment of ADCs or patient specific medications stored outside of ADCs.
Class II: Risk 11/06/2025 device

Due to a number of modules flashed with a date and time associated with the daylight savings time (DST) adjustment that may cause connectivity issue with hospital networks. This issue only affects the Interoperability workflow for devices with a DST invalid timestamp, impacting connectivity of the PCU to the hospital network
Class I: Dangerous 10/17/2025 device

If infusion pump is dropped or severely jarred this may damage the pump module bezel assembly, which can cause under-infusion, over-infusion, unregulated flow, or pump module failure to calibrate; so dropped/jarred pumps should be removed from use, tested, and inspected by qualified service personnel prior to reuse; tip sheet, cleaning and disinfecting procedure and reference guide updated.
Class II: Risk 09/30/2025 device

Potential fluid ingress of anesthesia station or med station may result in smoke, system downtime and/or fire.
Class II: Risk 09/30/2025 device

Potential fluid ingress of anesthesia station or med station may result in smoke, system downtime and/or fire.
Class II: Risk 09/30/2025 device

Potential fluid ingress of anesthesia station or med station may result in smoke, system downtime and/or fire.
Class II: Risk 09/30/2025 device

Potential fluid ingress of anesthesia station or med station may result in smoke, system downtime and/or fire.
Class II: Risk 09/30/2025 device

Potential fluid ingress of anesthesia station or med station may result in smoke, system downtime and/or fire.
Class I: Dangerous 09/11/2025 device

Infusion pump module used with compatible pump infusion sets may perform outside the established performance ranges for flow rate and bolus accuracy, downstream and upstream occlusion time to alarm, and post-occlusion bolos volume.
Class III: Low Risk 07/10/2025 device

Reports of delayed access to medication in automated dispensing cabinets because of the override/Add Item workflow.
Class I: Dangerous 07/08/2025 device

Infusion pump module used with compatible pump infusion sets may perform outside the established performance ranges for flow rate and bolus accuracy, downstream and upstream occlusion time to alarm, and post-occlusion bolos volume.
Class I: Dangerous 07/08/2025 device

Infusion pump module used with compatible pump infusion sets may perform outside the established performance ranges for flow rate and bolus accuracy, downstream and upstream occlusion time to alarm, and post-occlusion bolos volume.
Class II: Risk 05/08/2025 device

During automated dispensing cabinet upgrade/installation/reimaging, component manager was left in installed mode, and if a Microsoft patch is then installed this may lead to an error preventing user access to the dispensing software application, which may lead to delay in access to medications/supplies, and delivery/replenishment of patient specific orders; which may lead to delay in patient care.
Class II: Risk 05/08/2025 device

Antivirus software was not consistently installed on impacted devices during the implementation process.
Class II: Risk 03/11/2025 device

Due to a software bug, automated dispensing cabinet is unable to calculate countback discrepancies during the issue process, which causes incorrect transaction quantity to be recorded. This bug can also result in the CUBIE opening more times than needed for the transaction to be completed, which may result in a patient receiving more than the intended dose of medication.
Class II: Risk 03/11/2025 device

Due to a software issue, when attempting to restock the automated dispensing cabinet, user have received the banner message "Stocking window has passed, or item has been removed from purchase order. Please contact Pharmacy for assistance". When this occurs, the medication cannot be restocked and can potentially lead to delays in accessing medication for patients.
Class II: Risk 03/11/2025 device

Users trying to restock a single bin location of an automated dispensing cabinet, during pocket exchange restocking workflow, may experience a software issue that results in 2 destock transactions and 2 stock transactions, which results in doubling the bin quantity, which may result in a delay in access to desired medications and/or supplies, which may lead to temporary body function impairment.
Class I: Dangerous 02/18/2025 device

Software issue that may result in outdated automated programming request(APR) being sent to the progressive care unit (PCU).
Class I: Dangerous 02/18/2025 device

Software issue that may result in outdated automated programming request(APR) being sent to the progressive care unit (PCU).
Class II: Risk 02/06/2025 device

Sync timeout may occur between the server and automated dispensing device, due to a server software error which may occur if syncing a large amount of data that takes excessive time, which may cause the dispensing devices to become disconnected from the ES server; dispensing devices will not receive updated information, which may lead to incorrect therapy, and delay in accessing medication.
Class II: Risk 01/23/2025 device

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.
Class II: Risk 01/23/2025 device

Due to fingerprint scanner failing resulting in the scanner heating up.
Class II: Risk 01/10/2025 device

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.
Class II: Risk 01/08/2025 device

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
Class II: Risk 01/08/2025 device

Labeling update to include a contraindication statement against the use of medicine cabinets in procedure and operating rooms.
Class II: Risk 01/08/2025 device

Labeling update to include a contraindication statement against the use of medicine cabinets in procedure and operating rooms.
Class II: Risk 01/08/2025 device

Labeling update to include a contraindication statement against the use of medicine cabinets in procedure and operating rooms.
Class II: Risk 01/08/2025 device

Labeling update to include a contraindication statement against the use of medicine cabinets in procedure and operating rooms.
Class II: Risk 01/08/2025 device

Labeling is insufficient regarding delays in access to medication. The firm is strengthening the label as an additional risk mitigation.
Class II: Risk 11/14/2024 device

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.
Class II: Risk 11/14/2024 device

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.
Class II: Risk 11/14/2024 device

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.
Class II: Risk 08/15/2024 device

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.
Class II: Risk 08/15/2024 device

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.
Class II: Risk 08/15/2024 device

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.
Class II: Risk 08/15/2024 device

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.
Class II: Risk 08/15/2024 device

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.
Class II: Risk 07/09/2024 device

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.
Class II: Risk 07/09/2024 device

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.
Class II: Risk 06/24/2024 device

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.
Class II: Risk 06/24/2024 device

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.
Class II: Risk 06/24/2024 device

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.
Class II: Risk 06/24/2024 device

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.
Class II: Risk 06/24/2024 device

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.
Class II: Risk 06/24/2024 device

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.
Class II: Risk 06/24/2024 device

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.
Class II: Risk 06/24/2024 device

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.
Class II: Risk 06/24/2024 device

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.
Class II: Risk 06/24/2024 device

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.
Class II: Risk 06/24/2024 device

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.
Class II: Risk 06/24/2024 device

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.
Class II: Risk 06/24/2024 device

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.
Class II: Risk 06/24/2024 device

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.
Class II: Risk 06/24/2024 device

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.
Class II: Risk 06/24/2024 device

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.
Class II: Risk 06/24/2024 device

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.
Class II: Risk 06/24/2024 device

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.
Class II: Risk 06/24/2024 device

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.
Class II: Risk 05/21/2024 device

Due to a software issue the PC unit may not connect to the server which could impact wireless data transmission to and from the server.
Class II: Risk 05/13/2024 device

Multiple socket-outlet power strips that shipped with automated dispensing cabinet devices have not been certified to International Electrotechnical Commission (IEC) electrical standards when used as a system with automated dispensing cabinet devices, so use may expose user to leakage currents that could cause varying degrees of harm from a minor shock to permanent impairment.
Class II: Risk 05/13/2024 device

Multiple socket-outlet power strips that shipped with automated dispensing cabinet devices have not been certified to International Electrotechnical Commission (IEC) electrical standards when used as a system with automated dispensing cabinet devices, so use may expose user to leakage currents that could cause varying degrees of harm from a minor shock to permanent impairment.
Class II: Risk 05/02/2024 device

If automated dispensing cabinets have specific software versions, and Component Manager was configured to "installed mode", and software patch KB 5033688 was installed in the production environment, then this will will lead to an error that prevents the user from accessing the dispensing software application, which may delay accessing medication.
Class II: Risk 04/15/2024 device

Potential fluid ingress of anesthesia station or med station may result in smoke, system downtime and/or fire.
Class II: Risk 04/15/2024 device

Potential fluid ingress of anesthesia station or med station may result in smoke, system downtime and/or fire.

Data from FDA openFDA enforcement reports. This site is not affiliated with or endorsed by the FDA. Recall information may be updated by the FDA at any time.