The Recall Desk

Manufacturer

CareFusion 303, Inc.

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

What the numbers show

Total
173
Critical
2
Severe
14
Most recent
2026-06-10

Of the 173 recalls from CareFusion 303, Inc. we have scored against our rubric, 2 (1%) are Critical — deaths or serious injuries reported, or the agency’s own highest classification — and 14 (8%) are Severe.

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.

151–173 of 173

  • HighFDA (Devices)·Z-0445-2016·2015-12-30

    CareFusion Recalls Alaris Pump SmartSite Infusion Sets Due to Leakage Risk

    CareFusion is recalling Alaris Pump SmartSite Infusion Sets because disconnection and leakage may occur during infusion.

    Product
    Alaris Pump SmartSite Infusion Set, Model No. 2420-0500. Used to administer fluid and medications through a needle or catheter inserted into the patient's artery or vein.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0455-2016·2015-12-30

    CareFusion Recalls Alaris EtCO2 Module 8300 Due to Calibration Error

    CareFusion is recalling 157 Alaris EtCO2 Module 8300 units because they may have been tested with high CO2 concentrations, potentially causing incorrect measurements.

    Product
    Alaris EtCO2 Module, Model 8300. A capnograph that continuously monitors end tidal carbon dioxide (EtCO2), fractional inspired carbon dioxide (FiCO2), and respiratory rate (RR).
    Category
    Medical Device
    Distribution
    0 states
  • HighFDA (Devices)·Z-0221-2016·2015-11-11

    CareFusion Recalls SmartSite Extension Sets Due to Disconnection and Leakage

    CareFusion is recalling SmartSite Extension Sets because they may disconnect or leak. The recall affects 21,000 units distributed in the US and Canada.

    Product
    SmartSite Extension Set, Model No. 20029E. Used to administer fluid and medications through a needle or catheter inserted into the patient's artery or vein.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2362-2015·2015-08-26

    CareFusion Alaris Syringe Pump Recall for Unresponsive Control Defect

    CareFusion 303, Inc. is recalling Alaris Syringe Pumps, Model 8110, because they may become unresponsive to key presses after a channel error is cleared.

    Product
    Alaris Syringe Pump, Model No. 8110. Delivers fluids. Expansion of Affected Units: BOM Housing Assembly Service, Part No. 49000226, and Lower Housing/Carriage Block Assembly, Part No. 148188-100.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1811-2015·2015-06-24

    CareFusion Alaris PC Unit Infusion Pump Software Recall

    CareFusion 303, Inc. is recalling 63 Alaris PC unit model 8015 infusion pumps due to a software defect that may allow infusions to start outside hospital-established limits.

    Product
    Alaris PC unit model 8015, Infusion pump. software version 9.17 Product Usage: The Alaris PC unit is the central programming, monitoring and power supply component for the Alaris System. The software is embedded in the Alaris PC unit.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1311-2015·2015-04-01

    CareFusion Recalls Alaris PC Infusion Pumps Due to Keypad Error Code

    CareFusion 303, Inc. is recalling 56,015 Alaris PC infusion pumps because a keypad issue may trigger an error code during the power-on self-test.

    Product
    Alaris PC units, Model No. 8015. Infusion pump.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1053-2015·2015-02-11

    CareFusion Recalls SmartSite Infusion Sets Due to Disconnection and Leakage

    CareFusion is recalling 7,440 SmartSite Low Sorbing Infusion Sets due to disconnection and leakage issues.

    Product
    SmartSite Low Sorbing Infusion Set, Model No. 10015862 The SmartSite Infusion Sets are used to administer fluid and medications through a needle or catheter inserted into the patient's artery or vein. The set is comprised of components commonly found on intravascular administrat
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2025-2014·2014-07-16

    CareFusion Recalls SmartSite Infusion Sets Due to Unlabeled Filter

    CareFusion is recalling SmartSite Low Sorbing Infusion Sets because the drip chamber contains a 15-micron filter not listed in the instructions, posing a risk of occlusion if used with blood.

    Product
    SmartSite Low Sorbing Infusion Set, Model Codes: 10014855A, 10015861A, 10061661A 14035457 14035485 14046894 14035458
    Category
    Medical Device
    Distribution
    5 states
  • HighFDA (Devices)·Z-1567-2014·2014-05-21

    CareFusion Recalls Alaris Pump 8100 Due to Software Delay Issue

    CareFusion is recalling Alaris Pump model 8100 units with specific software versions because a defect may prevent the pump from properly delaying infusions.

    Product
    Alaris Pump model 8100 with software version 9.1.18 and software upgrade kits with "Delay Until" Option and "Multidose" Feature The Alaris Pump module is a large volume infusion pump offered under the Alaris System. The Alaris Pump module will deliver medication and fluids usi
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1459-2014·2014-04-23

    CareFusion SmartSite Extension Set Recalled for Tubing Disconnections and Leaks

    CareFusion 303, Inc. is recalling 7,700 SmartSite Extension Sets due to disconnections and leakages at the tubing and Y-port connection.

    Product
    SmartSite Extension Set, Model No. 20029E, intravascular administration set.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0931-2014·2014-02-12

    CareFusion Recalls Trifurcated Extension Sets Due to Potential Component Leak

    CareFusion 303, Inc. is recalling Trifurcated Extension Sets (models ME 1224 and MP 9230) because a defect in the trifurcated component could result in a leak.

    Product
    Trifurcated Extension Set, model no. ME 1224. Trifurcated Extension Set, model no. MP 9230.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0925-2014·2014-02-12

    CareFusion Recalls SmartSite Needleless Connectors Due to Connection Issues

    CareFusion is recalling SmartSite Needleless Connectors because they may unintentionally disconnect, be difficult to disconnect, or fail to disconnect from a female luer.

    Product
    SmartSite Needleless Connector, Model No. 2000E The SmartSite Needleless Connectors are sterile, individually packaged connectors. The connectors are used to administer fluid and medications. The needle free connector allows the user to add medication into the primary line wi
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0534-2014·2014-01-01

    CareFusion Recalls Alaris PC Units Due to System Error Messages

    CareFusion is recalling Alaris PC units because they may produce audible alarms and display System Error messages.

    Product
    Alaris PC unit model 8000 and 8015 with Alaris PCA module model 8120 and Auto ID barcode scanner model 8600. Product Usage: The Alaris PC unit is the central programming, monitoring and power supply component for the Alaris System. The Alaris PCA (Patient Controlled Analgesia
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0435-2014·2013-12-11

    CareFusion Recalls VersaSafe Extension Sets Due to Adhesive Defect

    CareFusion is recalling VersaSafe Extension Sets because excessive adhesive may prevent the male spin collar from operating as intended.

    Product
    VersaSafe Extension Set, Model No. 21000M-007
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0450-2014·2013-12-11

    CareFusion Recalls SmartSite Infusion Sets Due to Tubing Assembly Error

    CareFusion is recalling 480 units of SmartSite Low Sorbing Infusion Sets because they were not assembled with low-sorbing tubing.

    Product
    SmartSite Low Sorbing Infusion Set with Texium Close Male Luer, Model No. 24301-0007T The SmartSite Low Sorbing Infusion Sets with Texium Male Luer are used to administer fluid and medications through a needle or catheter inserted into the patient's artery or vein.
    Category
    Medical Device
    Distribution
    5 states
  • HighFDA (Devices)·Z-2285-2013·2013-10-02

    CareFusion Recalls SmartSite Infusion Sets Due to Tubing Separation Risk

    CareFusion is recalling SmartSite Low Sorbing Infusion Sets because the tubing sleeve may separate below the drip chamber.

    Product
    SmartSite Low Sorbing Infusion Set, Model# 10015048. Intravascular administration set.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-2281-2013·2013-10-02

    CareFusion Recalls Gravity Sets Due to Incorrect Expiration Date Labeling

    CareFusion is recalling 2,850 units of Gravity Set Model 44000-07 because they are labeled with a 5-year expiration date instead of the correct 3-year date.

    Product
    CareFusion Gravity Set, Model #44000-07 The CareFusion Gravity Sets are used to administer fluid and medication through a needle or catheter inserted into the patient's artery or vein. The CareFusion Gravity Set is comprised of components commonly found on intravascular admini
    Category
    Medical Device
    Distribution
    1 state
  • ModerateFDA (Devices)·Z-2279-2013·2013-10-02

    CareFusion Recalls SmartSite Infusion Sets Due to Incorrect Filter Assembly

    CareFusion is recalling 600 units of SmartSite Low Sorbing Infusion Sets because an incorrect 0.2 micron filter may have been assembled instead of the required 1.2 micron filter.

    Product
    SmartSite Low Sorbing Infusion Set, Model#72313E The SmartSite Low Sorbing Infusion Sets are used to administer fluid and medications through a needle or catheter inserted into the patient's artery or vein. The SmartSite Low Sorbing set is comprised of components commonly foun
    Category
    Medical Device
    Distribution
    4 states
  • ModerateFDA (Devices)·Z-1835-2013·2013-08-14

    CareFusion Recalls Alaris PC Units Due to Voltage and Communication Issues

    CareFusion is recalling Alaris PC units model 8015 because they operate at incorrect voltage and may lose communication between processors.

    Product
    Alaris PC unit, model 8015, with version 9.12-Keyboard Processor and logic board assembly part number TC10006584. The Alaris PC Unit is the main user interface unit and power supply of the Alaris System, a modular system to be used with Alaris System modules intended for use i
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0832-2013·2013-02-27

    CareFusion Recalls SmartSite Gravity Blood Sets Due to Connection Separation

    CareFusion is recalling 5,050 units of SmartSite Gravity Blood Sets because the drip chamber and tubing may separate, potentially delaying treatment.

    Product
    CareFusion SmartSite Gravity Blood Set Model 42082E. Used to administer blood and blood products through a needle or catheter inserted into the patient's artery or vein.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-2205-2012·2012-08-29

    CareFusion Recalls Alaris Pump Module 8100 Due to Keypad Overlay Separation

    CareFusion 303, Inc. is recalling Alaris Pump Module 8100 units because the keypad overlay may separate from the assembly, posing a potential risk.

    Product
    Alaris Pump Module Model 8100 (formerly Medley Pump Module) Subsequent Product Code: FPA. The Pump module is intended for facilities that utilize infusion for the delivery of fluids, medications, blood, and blood products using continuous or intermittent delivery through cl
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2185-2012·2012-08-22

    CareFusion Recalls Alaris Pump Module 8100 Due to Motor Stalls

    CareFusion 303, Inc. is recalling Alaris Pump Module model 8100 units due to reports of motor stalls during infusion.

    Product
    Alaris Pump Module model 8100. Subsequent product code: FPA The Pump module is intended for facilities that utilize infusion for the delivery of fluids, medications, blood, and blood products using continuous or intermittent delivery through clinically acceptable routes of
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-2076-2012·2012-08-01

    CareFusion Alaris PC Unit Model 8015 Recalled for Power Supply Board Error

    CareFusion 303, Inc. is recalling Alaris PC unit model 8015 devices because a power supply board component causes startup error codes and alarms.

    Product
    Alaris PC unit model 8015 Product Usage: The device is labeled for prescription use only.
    Category
    Medical Device
    Distribution
    Distributed nationwide