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.

126–150 of 173

  • SevereFDA (Devices)·Z-1362-2020·2020-03-11

    CareFusion Alaris PCA Module Recalled for Software Errors

    CareFusion 303, Inc. is recalling CareFusion Alaris PCA Module, Model 8120 units due to software errors that may cause infusion interruptions or incorrect medication concentrations.

    Product
    CareFusion Alaris PCA Module, Model 8120
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1360-2020·2020-03-11

    CareFusion Alaris Pump Module Recalled for Software Errors

    CareFusion 303, Inc. is recalling Alaris Pump Module Model 8100 units due to software errors that may cause infusion interruptions or incorrect medication concentrations.

    Product
    CareFusion Alaris Pump Module, Model 8100
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1361-2020·2020-03-11

    CareFusion Alaris Syringe Module Software Error Recall

    CareFusion 303, Inc. is recalling Alaris Syringe Module Model 8110 units due to software errors that may cause infusion interruptions or incorrect medication concentrations.

    Product
    CareFusion Alaris Syringe Module, Model 8110
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1359-2020·2020-03-11

    CareFusion Alaris PC Unit Software Error Recall

    CareFusion is recalling Alaris PC units due to software errors that may cause infusion interruptions, alarm failures, or incorrect medication concentrations.

    Product
    CareFusion Alaris System, Alaris PC unit models 8000 and 8015 (UDI: 10885403801518)
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-2443-2019·2019-09-11

    CareFusion Alaris EtCO2 Capnographs Recalled for Calibration Error

    CareFusion 303, Inc. is recalling 76 Alaris EtCO2 capnographs because they may have been calibrated with a lower-than-specified CO2 concentration.

    Product
    Alaris EtCO2, Model 8300, UDI: 10885403830013, CareFusion for models 11634567 and 8300ADXeN933
    Category
    Medical Device
    Distribution
    10 states
  • SevereFDA (Devices)·Z-1768-2019·2019-07-24

    CareFusion Recalls Alaris Pump Model 8100 Due to Bezel Plastic Weakening

    CareFusion is recalling Alaris Pump Model 8100 units manufactured between April 2011 and June 2017 because the bezel plastic may weaken, potentially causing infusion errors.

    Product
    Alaris Pump, Model 8100, with bezel mechanical assemblies manufactured with FR-110 plastic resin. The following products are affected by this recall as they are pumps or pump assemblies with bezels manufactured between April 2011 and June 2017 with the FR-110 plastic. Alar
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0385-2019·2018-11-14

    CareFusion Recalls Alaris Infusion Pump Administration Sets Due to Priming Issues

    CareFusion 303, Inc. is recalling Alaris Infusion Pump administration sets because users reported being unable to prime the devices.

    Product
    Alaris Infusion Pump administration sets labeled as: -Infusion Set Alaris Pump Module/Medley Pump Module/Gemini Infusion Pump, REF 10011301, CareFusion, WARNING: TO PREVENT FREE-FLOW, CLOSE SET CLAMP WHEN SAFETY CLAMP FITMENT ON PUMP SEGMENT IS OPEN, Fluid path is STERILE and
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2111-2018·2018-06-13

    CareFusion Recalls Alaris Extension Sets Due to Incorrect Tubing

    CareFusion 303, Inc. is recalling Alaris Extension Sets with microbore tubing because manufacturing errors resulted in incorrect priming volumes.

    Product
    Alaris Extension Sets with microbore tubing Model 20022 and 30914 Is used to administer fluid and medications from a syringe to the patient through a needle or catheter inserted into the patient's artery or vein. These model codes are extension sets that can be used with IV a
    Category
    Medical Device
    Distribution
    10 states
  • HighFDA (Devices)·Z-0322-2018·2018-01-17

    CareFusion Recalls Alaris Syringe Pumps Due to Plunger Gripper Failure

    CareFusion is recalling Alaris Syringe Pump Model 8110 units because the syringe plunger grippers may fail to close automatically, potentially affecting medication delivery.

    Product
    Alaris Syringe Pump, Model 8110. The firm name on the label is CareFusion. The Alaris Syringe Pump module and Alaris PCA module are infusion pump modules for the Alaris System. The syringe pump and PCA pump delivers medication or fluids in a manner similar to current syringe
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0323-2018·2018-01-17

    CareFusion Alaris PCA Pump Recall Due to Syringe Plunger Gripper Failure

    CareFusion is recalling Alaris PCA Pumps because the syringe plunger grippers may fail to close automatically, potentially affecting medication delivery.

    Product
    Alaris PCA Pump, Model 8120. The firm name on the label is CareFusion. The Alaris Syringe Pump module and Alaris PCA module are infusion pump modules for the Alaris System. The syringe pump and PCA pump delivers medication or fluids in a manner similar to current syringe pump
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0026-2018·2017-10-25

    CareFusion Recalls Alaris Pump Modules Due to Flow Rate Variations

    CareFusion 303, Inc. is recalling Alaris Pump Module model 8100 units due to reports of increased or decreased medication flows.

    Product
    Alaris Pump Module model 8100 manufactured between November 2011 and March 2012; Alaris Pump Module serviced with LVP Mechanism Sub Assembly (P/N) 10942012 between November 2011 and March 2012; Alaris Pump module Bezel Kit Assembly (P/N) 10964559) shipped between November 201
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-3030-2017·2017-08-23

    CareFusion Recalls VersaSafe Plastic Cannulas Due to Packaging Punctures

    CareFusion 303, Inc. is recalling 1,546,800 units of VersaSafe Plastic Cannulas because punctures were detected in the blister packaging during the manufacturing process.

    Product
    VersaSafe Plastic Cannula - 11 Gauge, Model 9391-0200 Product Usage: Used with secondary IV sets or syringes with a female luer lock adapter to administer fluid and medications through a needle or catheter inserted into a patients artery or vein.
    Category
    Medical Device
    Distribution
    8 states
  • HighFDA (Devices)·Z-2700-2017·2017-07-19

    CareFusion Recalls Alaris Pump Module 8100 Due to Latch Design Risk

    CareFusion 303, Inc. is recalling 35,940 Alaris Pump Module model 8100 units in the US and Canada due to a potential risk of unintended flow caused by the sear door latch design.

    Product
    Alaris Pump Module model 8100
    Category
    Medical Device
    Distribution
    0 states
  • HighFDA (Devices)·Z-1883-2017·2017-05-03

    CareFusion Recalls SmartSite Add-On Bag Access Device Due to Leakage

    CareFusion is recalling 384,923 units of the SmartSite Add-On Bag Access Device because the spike port may separate or leak, potentially interrupting medication infusion.

    Product
    SmartSite Add-On Bag Access Device, Model No. 10013365
    Category
    Medical Device
    Distribution
    0 states
  • HighFDA (Devices)·Z-1520-2017·2017-03-29

    CareFusion Alaris System PC Unit Recall for Battery Alarm Failure

    CareFusion is recalling Alaris System PC units because low battery alarms may fail to trigger before the battery discharges, stopping all infusion channels.

    Product
    Alaris System PC unit, model no. 8000 and 8015. The central programming, monitoring and power supply component for the Alaris infusion pump System.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1482-2017·2017-03-22

    CareFusion Recalls MaxGuard Extension Sets Due to Filter Leaks

    CareFusion is recalling 12,850 MaxGuard Extension Sets because the 0.2 micron filter may leak. These medical devices are used to administer fluids to patients.

    Product
    MaxGuard Extension Set, Model No. ME2064, MP9009C, MP9209, MP9254C The MaxGuard extension sets are used to administer fluids from a container to a patient s vascular system through a needle or catheter inserted into the patient s artery or vein. The extension sets may incorporat
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1464-2017·2017-03-22

    CareFusion Recalls MaxGuard Extension Sets Due to Leakage Reports

    CareFusion is recalling 1,200 MaxGuard Extension Sets because of reports of separation and leakage between the Y-connector and tubing.

    Product
    MaxGuard Extension Set with Injection Site and 0.2 micron filter, Model No. ME3305
    Category
    Medical Device
    Distribution
    2 states
  • HighFDA (Devices)·Z-0950-2017·2017-01-25

    CareFusion Recalls Alaris Pump Modules Due to False Air-in-Line Alarms

    CareFusion is recalling Alaris Pump Modules and AIL sensor kits because false Air-in-Line alarms can interrupt medication infusions.

    Product
    Alaris Pump Module, Model No. 8100 and AIL sensor kits, P/N 147083-102 and P/N 49000221. The Alaris Pump module is a large volume infusion pump offered under the Alaris System. The Alaris Pump module will deliver medication and fluids using IV administration sets for continuou
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2879-2016·2016-10-05

    CareFusion Recalls Alaris Syringe Modules Due to Software Anomaly

    CareFusion 303, Inc. is recalling Alaris Syringe Module Model 8110 units with software version 9.15 because a software anomaly may cause infusions to stop unexpectedly.

    Product
    Alaris Syringe Module Model 8110 with software version 9.15 The Alaris Syringe Pump module is part of the Alaris System. The syringe pump delivers fluids in a manner similar to current syringe pumps on the market. Up to four Alaris Syringe pump modules can be connected to the
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2064-2016·2016-07-06

    CareFusion Alaris System PC Unit Recall for Incorrect Patient Weight Data

    CareFusion 303, Inc. is recalling 69,693 Alaris System PC Units because the RESTORE feature may incorrectly populate patient weight for specific infusion modules.

    Product
    Alaris System PC Unit Model 8015 with software versions 9.17 and 9.19; Central programming, monitoring and power supply component for the Alaris System.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1606-2016·2016-05-11

    CareFusion Alaris PC Unit Model 8015 Recalled for Power-Up Error

    CareFusion 303, Inc. is recalling 23,397 Alaris PC units, Model 8015, because a super capacitor failure may cause a system error code at power-up.

    Product
    Alaris PC unit, Model 8015 The Alaris PC unit is the central programming, monitoring and power supply component for the Alaris System.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1239-2016·2016-03-30

    CareFusion Recalls Alaris PC Infusion Pump Units Due to Power Supply Error

    CareFusion is recalling 170 Alaris PC Unit Infusion Pump Model 8000 devices because a power supply component may cause system error codes.

    Product
    Alaris PC Unit, Infusion Pump Model 8000, Part No. TC10005092
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1179-2016·2016-03-23

    CareFusion Recalls Alaris VersaSafe Infusion Sets Due to Leakage

    CareFusion is recalling 5,760 Alaris VersaSafe Infusion Sets distributed in Michigan because the split septum port may separate or leak.

    Product
    Alaris Pump VersaSafe Infusion Set, Model No. 2122-0007
    Category
    Medical Device
    Distribution
    1 state
  • HighFDA (Devices)·Z-0814-2016·2016-02-24

    CareFusion Recalls Jadak Barcode Scanners for Pyxis Anesthesia Systems

    CareFusion 303, Inc. is recalling 9,345 Jadak Barcode Scanners used with Pyxis Anesthesia systems because they may transmit incorrect medication information to the dispensing system.

    Product
    Jadak Barcode Scanner, Part No. 350587-32, 350587-41, 351377-32. Product Usage: An accessory for the Pyxis Anesthesia ES system and Pyxis Anesthesia system 4000 stations. The Jadak Barcode Scanner is used to scan medication labels during refill of the Pyxis Anesthesia ES s
    Category
    Medical Device
    Distribution
    Distributed nationwide