The Recall Desk

Manufacturer

CareFusion 303, Inc.

95 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.

1–25 of 95

  • ModerateFDA (Devices)·Z-1645-2026·2026-04-01

    Infusion Pump Labeling Deficiency: Missing TLS Version Information for Wi-Fi Security

    BD Alaris infusion systems lack TLS version specifications in product labeling, preventing hospitals from ensuring secure Wi-Fi network communication. The labeling deficiency could result in improper network security configuration of the Point-of-Care Units.

    Product
    BD Alaris" System with Guardrails" Suite MX with Point of Care Unit
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1217-2026·2026-02-04

    BD Alaris Pump Module with Invalid Timestamp Causes Network Connectivity Issues

    CareFusion is recalling 189 BD Alaris Pump Module model 8100 units with invalid daylight savings time timestamps that prevent connection to hospital networks, affecting device interoperability.

    Product
    BD Alaris" Pump Module model 8100 UDI-DI code: 10885403810046 The BD AlarisTM System with Guardrails" Suite MX is a modular infusion pump and monitoring system for the continuous or intermittent administration of fluids to adult, pediatric, and neonatal patients through clini
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1028-2026·2026-01-14

    BD Pyxis ES Enterprise Server Software Defect May Delay Medication Updates

    A software issue in the BD Pyxis ES Enterprise Server may prevent timely updates of patient and medication information. The defect affects 2,079 systems distributed nationwide and in Canada and Bermuda.

    Product
    BD Pyxis ES Enterprise Server Catalog Numbers 1115-00, 137672-02,137672-03 137671-02, 137671-03, 137670-02, 137670-03, 139676-01, 139421-01, 139420-01, 139419-01, 139419-02, 139673-01, 137081-01, 136451-01, 136451-02, 136450-01, 136450-02, 136449-01, 136449-02, 134148-01, 133760
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0962-2026·2025-12-31

    Automated Dispensing Cabinet Firmware Update Causes Drawer Malfunction

    A firmware update to BD Pyxis automated medication dispensing cabinets causes drawer failure, potentially delaying access to critical hospital medications.

    Product
    BD Pyxis MedStation ES, REF: 323, BD Pyxis MedStation ES 7 Drawer Auxiliary, REF: 324, BD Pyxis MedStation ES Tower, REF: 352, BD Pyxis Pro 7-Drawer Auxiliary, REF: 1149-00, BD Pyxis Pro 7- Drawer Auxiliary with Secure Tower, REF: 1152-00, BD Pyxis Pro MedStation Main,
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-0430-2026·2025-11-26

    BD Alaris Infusion Pump Module 8100 Recall: Risk of Malfunction if Dropped

    CareFusion recalls BD Alaris infusion pump modules distributed worldwide. Dropping or jarring may damage the bezel assembly, causing under-infusion, over-infusion, or pump failure; affected pumps must be removed from service and inspected by qualified personnel.

    Product
    BD Alaris infusion Pump Module 8100, REF: 8100; KIT, BEZEL ASSY 8100BD, REF: 49000437; KIT ASSY ONE PIECE BEZEL 8100, REF: 49000270. Used with the following new and updated documents: BD Alaris Infusion System Inspection Safety Reminder, Part: BD-163124, Revision: 00; Clean
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0370-2026·2025-11-05

    BD Pyxis Pro MedStation Recalled for Fire Risk from Fluid Ingress

    CareFusion 303, Inc. is recalling 27 BD Pyxis Pro MedStation units due to potential fluid ingress that may cause smoke, fire, or system failure. The recall affects units distributed worldwide including the US, Canada, UAE, and Australia.

    Product
    BD Pyxis Pro MedStation Main, REF: 1155-00
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0368-2026·2025-11-05

    Medication and Anesthesia Stations Recalled for Potential Fire and Smoke Hazard

    BD Pyxis MedFlex medication and anesthesia stations are being recalled due to potential fluid ingress that may cause smoke, system failures, or fire. The recall affects 2,755 units distributed worldwide.

    Product
    Various models of BD Pyxis MedFlex, Reference numbers: 1119-00 1139-00 139038-01 139039-01 139040-01 139041-01 139043-01 139044-01 139045-01 139046-01 139049-01 139051-01 139052-01 139053-01 139054-01 139055-01 139056-01 139058-01 139059-01 139060-01 139061-0
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0369-2026·2025-11-05

    BD Pyxis Pro 7-Drawer Auxiliary medication dispensing unit fire hazard

    CareFusion is recalling 32 BD Pyxis Pro 7-Drawer Auxiliary medication dispensing units due to potential fluid ingress that could cause smoke, system failure, or fire in healthcare facilities worldwide.

    Product
    Various models of BD Pyxis Pro 7-Drawer Auxiliary, Reference numbers: 1149-00 and 1152-00
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0371-2026·2025-11-05

    BD Pyxis CII Safe ES Tower: Fluid Ingress Fire Risk Recall

    CareFusion 303, Inc. is recalling 443 BD Pyxis CII Safe ES Tower Main units due to potential fluid ingress that may cause smoke, system downtime, or fire in healthcare anesthesia and medication stations worldwide.

    Product
    All Serial Numbers/BD Pyxis CII Safe ES Tower Main, REF: 1116-00
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0367-2026·2025-11-05

    BD Pyxis Medbank Medication and Anesthesia Stations Recalled for Fire Risk

    CareFusion is recalling BD Pyxis Medbank medication and anesthesia dispensing stations due to potential fluid ingress that could cause fire or smoke. The recall affects approximately 8,262 units distributed worldwide.

    Product
    Various models of BD Pyxis Medbank: Reference numbers: 1137-00 1145-00 1146-00 1147-00 1148-00 138902-01 138903-01 138905-01 138906-01 138907-01 138908-01 138909-01 138910-01 138911-01 138912-01 138913-01 138914-01 138915-01 138916-01 138917-01 138918-01 13
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-0035-2026·2025-10-15

    BD Alaris Pump Infusion Sets May Deliver Inaccurate Doses

    BD Alaris Pump Infusion Sets may operate outside established performance ranges for flow rate, bolus accuracy, and occlusion detection, potentially delivering incorrect medication doses to patients receiving intravenous therapy.

    Product
    BD Alaris Pump Infusion Sets for the following reference numbers: C24101E, Amber Tubing, 15 Micron Filter, 0.2 Micron Filter, SmartSite Y-Site 10015414, 180 Micron Filter 2447-0007, Ball Valve SmartSite Port (Burette) 2 SmartSites Y-Sites 24201-0007, 2 SmartSite Y-sites
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-2477-2025·2025-09-03

    BD Pyxis automated medication systems recalled for missing antivirus software

    BD Pyxis automated medication dispensing systems are recalled because antivirus software was not consistently installed during the implementation process, affecting 8,353 devices worldwide.

    Product
    BD Pyxis Product Name / UDI-DI code / Catalog No. BD Pyxis" MedStation" 4000 Main / 10885403512629 / 303 BD Pyxis" MedStation" ES Tower / 10885403512674 / 352 BD Pyxis" Anesthesia Station ES / 10885403477836 / 327 BD Pyxis" MedStation" ES (Main) / 10885403512667 / 323
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-2321-2025·2025-08-20

    BD PYXIS MEDBANK Automated Dispensing Cabinets: Delayed Medication Access Risk

    Automated medication dispensing cabinets may delay access to medications due to a workflow defect in the override/Add Item function. The issue affects healthcare facilities nationwide.

    Product
    Description/REF: BD PYXIS MEDBANK MINI 1FH-1FM/169-137, BD PYXIS MEDBANK MINI 4HM/169-113, BD PYXIS MEDBANK MINI 4HH/169-112, BD PYXIS MEDBANK MINI 3HH-1HM/169-111, BD PYXIS MEDBANK MINI 3HH-1FG/169-110, BD PYXIS MEDBANK MINI 2HM-1FM/169-109, BD PYXIS MEDBANK MINI 2HH-
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-2180-2025·2025-08-13

    BD Alaris Pump Infusion Sets may deliver medication outside safe parameters

    BD Alaris Pump Infusion Sets may operate outside established performance ranges for flow rate and bolus accuracy, potentially delivering incorrect medication doses. Patients and healthcare providers should contact CareFusion.

    Product
    BD Alaris Pump Infusion Sets REF: 10013186, BD Alaris Pump Infusion Set, Back Check Valve, 3 SmartSite Y-sites LVP 60D DEHP FREE 3SS CV; REF: 2452-0007, BD Alaris Pump Infusion Set, 2 Back Check Valves, 3 SmartSite Y-sitesAS LVP 10D 3SS 2CV; REF: 2204-0007, BD Alaris Pum
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-2179-2025·2025-08-13

    BD Alaris Infusion Pump Module 8100 May Deliver Inaccurate Doses

    The BD Alaris Pump Module 8100 may deliver medication at incorrect flow rates, inaccurate bolus volumes, and may fail to detect occlusions on time. Over 33 million units are affected.

    Product
    BD Alaris Pump Module Model, 8100 with Guardrails, Suite MX software versions
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2017-2025·2025-07-02

    Software error in BD Pyxis cabinets can delay medication dispensing

    BD Pyxis medication dispensing cabinets may experience a software error during installation that prevents user access to the medication application, potentially delaying access to patient medications and supplies.

    Product
    Product Name [REF]: Supply Server, CCE Enterprise SW Site License (2-5), BD Pyxis Logistics [806], BD Pyxis MedStation 4000 Main 10885403512629 [303], BD Pyxis MedStation ES Tower 10885403512674 [352], BD Pyxis Anesthesia Station ES 10885403477836 [327], BD Pyxis MedStation ES (M
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1639-2025·2025-04-30

    Automated Dispensing Cabinet Software Bug Causes Double Inventory Quantities

    BD PYXIS automated dispensing cabinets have a software bug that can double bin quantities during restocking, potentially delaying medication access.

    Product
    BD PYXIS MEDBANK (Name, REF): MEDPASS MODULE, 139088-01; MINI 1FH-1FM, 169-137; MINI 1HH-1FH-1HM, 169-101; MINI 1HH-1HM-1FM, 169-102; MINI 2FH, 138902-01; MINI 2FH, 169-104; MINI 2FM, 169-105; MINI 2HH-1FH, 169-106; MINI 2HH-1FH, 138908-01; MINI 2HH-1FM, 169-107; MINI
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1552-2025·2025-04-23

    BD Pyxis MedBank software bypass allows incorrect medication dispensing

    CareFusion's BD Pyxis MedBank receiving cabinet software contains a flaw that can bypass pharmacist validation when 'Clear All' is selected, potentially allowing unintended medication removal. The recall affects 2,679 units distributed nationwide.

    Product
    MEDFLEX, REF: 1119-00; MEDBANK MAIN, REF: 1137-00; MEDFLEX 2.0, REF: 1139-00; MEDBANK TOWER MAIN, REF: 1145-00; MEDBANK MINI MAIN, REF: 1147-00 BD PYXIS MEDBANK Facility Software, REF: 139090-01; BD PYXS MEDBNK TWR MN 2HH1FH2HM2FM2FG1FF, REF: 169-100; BD PYXIS MEDBANK MINI 1HH-1F
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1545-2025·2025-04-16

    Automated Dispensing Cabinets Software Bug Risk of Medication Overdose

    CareFusion's BD Pyxis automated medication dispensing cabinets contain a software bug that prevents proper tracking of medication quantities, potentially causing patients to receive more medication than prescribed.

    Product
    BD Pyxis" MedBank" Mini and BD Pyxis" MedBank" Tower, BD Pyxis" MedFlex, BD Pyxis" MedBank" MedPass are automated dispensing cabinets (ADC) intended to securely store and dispense medications to a qualified and authorized user in a clinical settings.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1550-2025·2025-04-16

    Software defect in automated medication dispensing cabinet prevents restocking

    A software defect in BD Pyxis MedBank dispensing cabinets prevents medication restocking, potentially delaying patient access. Affected cabinets display an error message blocking the restocking process.

    Product
    BD Pyxis MedBank CUBIE Replenishment Station Product / Material ID BD PYXIS MEDBANK TWR MN CR-10HH-2FM-P / 155141-01 BD PYXIS MEDBANK TWR MN CR-10HH-2FH-P / 155140-01 BD PYXIS MEDBANK TWR MN CR-12HH-1FH / 155142-01 BD PYXIS MEDBANK TWR MN CR-12HH-1FM-P / 155143-01 BD PYXI
    Category
    Medical Device
    Distribution
    32 states
  • HighFDA (Devices)·Z-1375-2025·2025-03-26

    BD Pyxis Medication Dispensing Systems Software Sync Error Recall

    BD Pyxis medication dispensing systems may disconnect from their server due to a software error, preventing them from receiving medication updates. This could lead to incorrect medication administration or delayed access to medications.

    Product
    BD Pyxis: Anesthesia Station ES, REF: 327, MedStation ES, REF: 323, MedStation ES Tower, REF: 352, CII Safe ES, REF: 1116-00, CII Safe ES Desktop PC, REF: 1156-00, CII Safe ES Desktop PC, Wired SCNR, REF: 107-254-01, CII Safe ES Desktop PC, W-less SCNR, REF: 107-255-01,
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-1305-2025·2025-03-19

    BD Care Coordination Engine Software May Send Outdated Programming Requests

    BD Care Coordination Engine infusion software may send outdated automated programming requests to care units. Healthcare facilities in affected US states should review their systems.

    Product
    BD Care Coordination Engine (CCE) Infusion Adapter, Safety Management Software
    Category
    Medical Device
    Distribution
    21 states
  • SevereFDA (Devices)·Z-1304-2025·2025-03-19

    BD Alaris Systems Manager Infusion Software Affected by Programming Request Issue

    BD Alaris Systems Manager software may transmit outdated automated programming requests to progressive care units. The FDA has classified this as a Class I recall.

    Product
    BD Alaris Systems Manager , REF 9601 Infusion Safety Management Software
    Category
    Medical Device
    Distribution
    21 states
  • HighFDA (Devices)·Z-1231-2025·2025-03-05

    Infusion Pump Manual Instructs Users to Leave Safety Clamp Open

    BD Alaris Pump Module user manual incorrectly instructs users to leave the safety clamp open when reloading infusion sets, potentially causing accidental over-infusion.

    Product
    BD Alaris Pump Module REF 8100 The BD Alaris System with Guardrails Suite MX is a modular infusion pump and monitoring system for the continuous or intermittent administration of fluids to adult, pediatric, and neonatal patients through clinically accepted routes of administra
    Category
    Medical Device
    Distribution
    51 states
  • HighFDA (Devices)·Z-1230-2025·2025-03-05

    BD Pyxis MedBank medication cabinets recalled for operating room contraindication labeling

    CareFusion is recalling BD Pyxis MedBank medication management cabinets due to inadequate labeling. A contraindication statement must be added to warn against use in procedure and operating rooms.

    Product
    139088-01 BD PYXIS MEDBANK MEDPASS MODULE 169-151 BD PYXIS MEDBANK MINI 1FH-2HH MEDPASS 169-152 BD PYXIS MEDBANK MINI 2HH-1FM MEDPASS 169-150 BD PYXIS MEDBANK MINI 4HH MEDPASS 169-140 BD PYXIS MEDBANK TWR MN 3FH-8HH MEDPASS
    Category
    Medical Device
    Distribution
    Distributed nationwide