The Recall Desk

Manufacturer

CareFusion 303, Inc.

103 recalls in our database name CareFusion 303, Inc. as the manufacturing or recalling firm.

About this listing

The manufacturer string comes from the agency’s own source notice — for FDA recalls, the “recalling firm” field; for NHTSA recalls, the vehicle manufacturer; for CPSC recalls, the firm-of-record on the joint press release. A single corporate family can appear under multiple manufacturer strings as agency notices aren’t standardized on a canonical name. If you don’t see recalls you expect, try a parent-company search or a broader full-text search.

Severity scores below are computed from the agency’s classification and the recall text, never from manufacturer behaviour or history. Many manufacturers issue routine corrective actions (software updates, labelling corrections) that are correctly scored low — having recalls on this list isn’t inherently a quality signal.

76–100 of 103

  • HighFDA (Devices)·Z-2487-2024·2024-08-14

    BD PYXIS medication cabinet software error causes incorrect bin labels

    A software issue in the BD PYXIS MDBNK medication dispensing cabinet may cause restock labels to print with incorrect bin locations, potentially affecting medication storage accuracy.

    Product
    BD PYXIS MDBNK TWR MN CR-4HH-5FM-P RxNow, REF: 169-131 containing software version 3.9.1.9
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2488-2024·2024-08-14

    BD PYXIS Automated Medication Cabinet Software Label Error Affects 11 Units

    CareFusion's BD PYXIS medication dispensing cabinet with software version 3.9.1.9 may print incorrect bin labels during restocking, potentially leading to wrong medication dispensing. Eleven units distributed nationwide are affected.

    Product
    BD PYXIS MEDBANK TWR MN CR-10HH-2FH-P, REF: 169-82 containing software version 3.9.1.9
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2494-2024·2024-08-14

    Medication Dispensing Cabinet Software Defect Causes Incorrect Bin Labels

    BD PYXIS automated medication dispensing cabinets contain a software issue that may print incorrect bin locations on restock labels. This could result in medications being placed in the wrong bin during restocking.

    Product
    BD PYXIS MEDBANK TWR MN CR-2HH-6FM, REF: 169-89 containing software version 3.9.1.9
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2485-2024·2024-08-14

    Automated medication cabinet software prints incorrect bin labels

    The BD PYXIS MEDBANK MINI automated dispensing cabinet software may print incorrect bin locations on restock labels, potentially causing medications to be placed in wrong locations.

    Product
    BD PYXIS MEDBANK MINI CR-2HH-1FH-P, REF: 169-114 containing software version 3.9.1.9
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2486-2024·2024-08-14

    Automated dispensing cabinet software issue causes incorrect medication bin labels

    CareFusion is recalling 232 automated medication dispensing cabinets due to a software issue that may print incorrect medication bin labels, potentially causing medication dispensing errors.

    Product
    BD PYXIS MEDBANK MINI CR-4HH-P, REF: 169-115 containing software version 3.9.1.9
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2499-2024·2024-08-14

    Automated Medication Dispenser Software Bug Causes Incorrect Bin Labels

    BD PYXIS MEDBANK automated medication dispensers may print incorrect medication bin labels due to a software defect, risking medication handling errors in healthcare settings.

    Product
    BD PYXIS MEDBANK TWR MN CR-6HH-4FM-P, REF: 169-94 containing software version 3.9.1.9
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2374-2024·2024-07-24

    BD Pyxis Automated Dispensing Cabinets Software Error Prevents Medication Access

    BD Pyxis automated dispensing cabinets with ES 1.7.x software may display errors preventing medication access when Component Manager is in 'installed mode' and patch KB 5033688 is applied.

    Product
    BD Pyxis: MedStation ES (Main), REF: 323; MedStation ES Tower, REF: 352; Anesthesia Station ES, REF: 327; CII Safe ES, REF: 1116-00; CII Safe ES, Desktop PC, Wired Scanner, REF: 107-254-01; CII Safe ES, Desktop PC, Wireless Scanner, REF: 107-255-01; CII Safe ES, Desktop PC,
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2256-2024·2024-07-10

    BD Pyxis automated dispensing cabinets with noncertified power strips

    BD Pyxis automated dispensing cabinets were shipped with socket-outlet power strips that lack IEC electrical certification, potentially exposing users to leakage currents and electric shock.

    Product
    BD Pyxis, Name/REF: BD PYXIS MB TOWER MAIN/ 169-153, BD PYXIS MB TOWER MAIN CR/ 169-154, BD PYXIS MB TOWER MAIN W/MP/ 169-157, BD PYXIS MB TWR MN 1FM-10HH-1FH MP/ 169-143, BD PYXIS MB TWR MN 2FH-1FM-4HH-2FM MP/ 169-145, BD PYXIS MB TWR MN 2FM-8HH-1FH MP/ 169-144, BD PYXIS MB TWR
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2255-2024·2024-07-10

    BD Pyxis Medication Cabinets Recalled for Uncertified Power Strip Safety Risk

    BD Pyxis MEDBANK medication cabinets contain power strips not certified to electrical safety standards, potentially exposing users to leakage currents. The recall affects 677 units distributed nationwide.

    Product
    BD Pyxis, Name/REF: MEDBANK MINI 1FH-1FM/ 169-137, MEDBANK MINI 1FH-2HH MEDPASS/ 169-151, MEDBANK MINI 1HH-1FH-1HM/ 169-101, MEDBANK MINI 1HH-1HM-1FM/ 169-102, MEDBANK MINI 1HH-3HM/ 169-103, MEDBANK MINI 2FH/ 169-104, MEDBANK MINI 2FM/ 169-105, MEDBANK MINI 2HH-1FH/ 169-
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2262-2024·2024-07-10

    BD Alaris System Manager Software Connectivity Issue Recalled Nationwide

    A software issue in BD Alaris System Manager version 12.5.1 may prevent the PC unit from connecting to the server, potentially affecting wireless data transmission. CareFusion 303, Inc. is recalling the affected software version nationwide.

    Product
    BD Alaris System Manager REF: 9601, compatible with BD Alaris PC Units
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1929-2024·2024-06-05

    BD Pyxis MedStation ES 7-Drawer Auxiliary Tower Recalled for Fire Risk

    CareFusion recalled 87,302 units of the BD Pyxis MedStation ES 7-Drawer Auxiliary Tower due to potential fluid ingress that could cause smoke, system downtime, or fire.

    Product
    BD Pyxis" MedStation ES 7-Drawer Auxiliary Tower, REF: 324
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1931-2024·2024-06-05

    BD Pyxis Anesthesia Station ES units recalled for potential fire and smoke risk

    CareFusion 303, Inc. is recalling approximately 71,569 BD Pyxis Anesthesia Station ES units worldwide due to potential fluid ingress that could cause smoke, system downtime, or fire.

    Product
    BD Pyxis" Anesthesia Station ES, REF: 327
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1930-2024·2024-06-05

    BD Pyxis MedStation 4000 Auxiliary Tower: Potential Fluid Ingress Fire Risk

    The BD Pyxis MedStation 4000 Auxiliary Tower may allow fluid to enter the system, potentially causing smoke, system downtime, and fire. The FDA Class II recall affects 35,029 units distributed worldwide.

    Product
    BD Pyxis MedStation 4000 7-Drawer Auxiliary Tower, REF: 306
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1928-2024·2024-06-05

    BD Pyxis MedStation 4000 Medication Cabinet Fire Risk Recall

    CareFusion 303, Inc. is recalling approximately 91,933 units of the BD Pyxis MedStation 4000 System medication cabinet worldwide due to potential fluid ingress that may cause smoke, fire, or system downtime.

    Product
    BD Pyxis MedStation 4000 System, REF: 303, Medication Cabinet
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1927-2024·2024-06-05

    BD Pyxis MedStation ES Medication Cabinet Fluid Ingress Fire Hazard

    BD Pyxis MedStation ES medication cabinets may experience fluid ingress, potentially causing smoke, fire, or system downtime. CareFusion is recalling 212,367 units globally.

    Product
    BD Pyxis MedStation ES, REF: 323, Medication Cabinet
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1932-2024·2024-06-05

    BD Pyxis Anesthesia Station 4000 Recalled for Fluid Ingress Fire Risk

    CareFusion's BD Pyxis Anesthesia Station 4000 is recalled due to potential fluid ingress that may cause smoke, fire, or system downtime. The recall involves 11,875 units distributed worldwide.

    Product
    BD Pyxis(TM) Anesthesia Station 4000, REF: 338
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1223-2024·2024-03-13

    Automated medication dispensing cabinets may randomly freeze, crash, or hang

    BD Pyxis automated dispensing cabinets with affected software may randomly hang, freeze, or crash, potentially delaying medication access and causing data loss. Approximately 20,443 units are affected worldwide.

    Product
    BD Pyxis: MedStation ES, REF: 323; Anesthesia Station ES, REF: 327; MedStation ES Tower, REF: 352;
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-0184-2024·2023-11-15

    Alaris PCA Module 8120 infusion pump recalled for unvalidated syringes

    CareFusion 303, Inc. is recalling the Alaris PCA Module 8120 infusion pump because its labeling lists compatible syringes that have not been validated. This Class I recall affects 867,362 units worldwide.

    Product
    BD Alaris PCU REF 8015
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0185-2024·2023-11-15

    BD Alaris Syringe Module includes non-validated compatible syringes in labeling

    CareFusion is recalling 133,727 units of the BD Alaris Syringe Module because the labeling lists compatible syringes that have not been validated for use with the infusion pump.

    Product
    BD Alaris Syringe Module, REF 8110
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0093-2024·2023-10-18

    BD Pyxis CII Safe ES Software Flaw Disables Controlled Substance Safeguards

    Certain BD Pyxis CII Safe ES software versions (1.7.3 and 1.7.4) can silently disable critical controlled substance tracking safeguards when multiple settings are updated at once, potentially allowing diversion. No incidents have been reported.

    Product
    BD Pyxis CII Safe ES, REF: 1116-00; and BD Pyxis : CII Safe ES Desktop PC, Wired SCNR, REF: 107-254-01; CII Safe ES Desktop PC, W-LESS SCNR, BIO, REF: 107-255-01; Enterprise Server, REF: 1115-00, 134157-01, 137670-02, 134148-01, 135292-01, 136449-01, 133760-01
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2646-2023·2023-10-04

    Medical Device Software May Display Duplicate Medication Doses

    BD Pyxis MedBank MedPass Software may continue displaying dispensed medication doses as available, risking duplicate medication administration to patients.

    Product
    BD Pyxis MedBank MedPass Software, REF: 139088-01
    Category
    Medical Device
    Distribution
    3 states
  • HighFDA (Devices)·Z-2094-2023·2023-07-12

    BD Pyxis CII Safe Dispensing Cabinets Recalled for Electrical Current Leakage

    BD Pyxis CII Safe automated dispensing cabinets may leak excessive electrical current when connected to multi-socket power strips, risking electric shock and system downtime.

    Product
    BD Pyxis CII Safe, Software: V7, REF: 107-96, 107-97, 107-97-201; BD Pyxis CII Safe, Software: V7, REF: 107-223, 107-224, 111-191, 111-192, 111-193, 111-194, 111-195, 111-196, 111-197, 111-198; BD Pyxis CII Safe, Software: V8, 111-199-01, 111-200-01, 111-201-01, 111-202-01, 111-2
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1579-2023·2023-05-17

    BD Pyxis MedStation ES software failure causes patient data loss

    BD Pyxis automated dispensing cabinet software versions 1.7.0 through 1.7.4 experience download failures causing partial loss of patient information and transaction data. This may result in dispensing incorrect medication doses, allergenic medications, or discontinued medications.

    Product
    BD Pyxis MedStation ES (Med ES Main), REF: 323; BD Pyxis MedStation ES (Med ES Main Tower), REF: 352; BD Pyxis Anesthesia Station ES, REF: 327; BD Pyxis CII Safe ES Tower Main, REF: 1116-00; BD Pyxis CII Safe ES, Desktop PC, W-LESS SCNR, BIO, REF: 107-255-01
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1207-2023·2023-03-29

    BD Pyxis Automated Medication Dispensing Systems Firmware Downgrade Recall

    CareFusion recalls 7,914 units of BD Pyxis automated medication dispensing systems after firmware was inadvertently downgraded during installation, potentially causing drawer failures and medication delivery delays.

    Product
    BD Pyxis Anesthesia ES System (PAS ES), REF: 327; BP Pyxis MedStation ES (Med ES Main), REF: 323; BD Pyxis MedStation ES Tower (Med ES Tower), REF: 352; all with BD Pyxis ES version 1.6.1 drawer firmware (version 1.10.2.5). Pyxis MedStation Enterprise Server (ES) System is an a
    Category
    Medical Device
    Distribution
    Distributed nationwide