CareFusion 303, Inc. recalls
99 recalls in our records from 2012 to 2026: 99 FDA medical devices.
Recalls with full detail pages
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CareFusion 303, Inc. medical device recall: BD Alaris infusion Pump Module 8100
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…
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CareFusion 303, Inc. medical device recall: BD Alaris Pump Infusion Sets for the following reference numbers:…
Infusion pump module used with compatible pump infusion sets may perform outside the established performance ranges for flow rate and bolus accuracy, downstream and…
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CareFusion 303, Inc. medical device recall: BD Alaris Pump Module Model
Infusion pump module used with compatible pump infusion sets may perform outside the established performance ranges for flow rate and bolus accuracy, downstream and…
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CareFusion 303, Inc. medical device recall: BD Alaris Systems Manager
Software issue that may result in outdated automated programming request(APR) being sent to the progressive care unit (PCU).
Earlier and other recalls
These link to the official agency notice.
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CareFusion 303, Inc. medical device recall: BD Pyxis MedStation 4000 REF: 303 Medication cabinet Official notice ↗
Fingerprint scanner may overheat to a temperature to cause 1st degree burn.
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CareFusion 303, Inc. medical device recall: BD Alaris" System with Guardrails" Suite MX with Point of Care Unit Official notice ↗
Due to product labeling not indicating which Transport Layer Security (TLS) version that must be enabled on hospital network to ensure secure Wi-Fi communication with…
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CareFusion 303, Inc. medical device recall: BD Alaris" Pump Module model 8100 UDI-DI code: 10885403810046 The BD… Official notice ↗
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…
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CareFusion 303, Inc. medical device recall: BD Pyxis ES Enterprise Server Catalog Numbers 1115-00 Official notice ↗
Due a software issue that may result in equipment not receiving timely updates of patient, medication, or related information from enterprise systems.
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CareFusion 303, Inc. medical device recall: BD Pyxis MedStation ES Official notice ↗
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…
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CareFusion 303, Inc. medical device recall: Various models of BD Pyxis Medbank: Reference numbers: 1137-00… Official notice ↗
Potential fluid ingress of anesthesia station or med station may result in smoke, system downtime and/or fire.
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CareFusion 303, Inc. medical device recall: BD Pyxis Product Name / UDI-DI code / Catalog No. BD Pyxis"… Official notice ↗
Antivirus software was not consistently installed on impacted devices during the implementation process.
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CareFusion 303, Inc. medical device recall: Description/REF: BD PYXIS MEDBANK MINI 1FH-1FM/169-137 Official notice ↗
Reports of delayed access to medication in automated dispensing cabinets because of the override/Add Item workflow.
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CareFusion 303, Inc. medical device recall: Product Name [REF]: Supply Server Official notice ↗
During automated dispensing cabinet upgrade/installation/reimaging, component manager was left in installed mode, and if a Microsoft patch is then installed this may…
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CareFusion 303, Inc. medical device recall: Bd Pyxis Medbank Official notice ↗
Users trying to restock a single bin location of an automated dispensing cabinet, during pocket exchange restocking workflow, may experience a software issue that…
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CareFusion 303, Inc. medical device recall: Medflex Official notice ↗
If "Clear All" selected medications is selected on patient profile, the automated dispensing cabinet may allow dispensing of medication without first requiring the…
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CareFusion 303, Inc. medical device recall: BD Pyxis" MedBank" Mini and BD Pyxis" MedBank" Tower Official notice ↗
Due to a software bug, automated dispensing cabinet is unable to calculate countback discrepancies during the issue process, which causes incorrect transaction quantity…
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CareFusion 303, Inc. medical device recall: BD Pyxis MedBank CUBIE Replenishment Station Product / Material ID BD… Official notice ↗
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…
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CareFusion 303, Inc. medical device recall: BD Pyxis: Anesthesia Station ES Official notice ↗
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…
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CareFusion 303, Inc. medical device recall: BD Pyxis: MedFlex Official notice ↗
Automated dispensing device labeling is being updated to strengthen labeling around manual access to medications to address the risk of potential delays in retrieving…
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CareFusion 303, Inc. medical device recall: 138913-01 Bd Pyxis Medbank Mini Cr-2Hh-1Fh-P 169-114 Bd Pyxis Medbank… Official notice ↗
Labeling update to include a contraindication statement against the use of medicine cabinets in procedure and operating rooms.
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CareFusion 303, Inc. medical device recall: BD Alaris Pump Module REF 8100 The BD Alaris System with Guardrails… Official notice ↗
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…
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CareFusion 303, Inc. medical device recall: BD Pyxis MedFlex 2.0 REF 1139-00 Bio-ID Spare Parts REF 353200-01 The… Official notice ↗
Due to fingerprint scanner failing resulting in the scanner heating up.
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CareFusion 303, Inc. medical device recall: (1) BD Pyxis MedStation ES Official notice ↗
Labeling is insufficient regarding delays in access to medication. The firm is strengthening the label as an additional risk mitigation.
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CareFusion 303, Inc. medical device recall: (1) Pyxis MedStation ES Official notice ↗
Software issues could potentially result in: 1) delays in accessing dispensing software application, 2) wrong therapy (dose, item, timing, etc.), or 3) unauthorized…
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CareFusion 303, Inc. medical device recall: BD Pyxis MedStation ES Official notice ↗
Retroactive-Due to increase in complaints, their is a potential for drawer and/or door failures of the medication cabinet which could result in delay in accessing…
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CareFusion 303, Inc. medical device recall: BD Pyxis MedStation ES AUX Tower REF 343 BD Pyxis " MedStation 4000… Official notice ↗
Due to an increase in complaints of door latch assembly failures that may cause the doors to be left in an open state potentially causing inventory discrepancies, a…
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CareFusion 303, Inc. medical device recall: BD Pyxis MedStation ES Official notice ↗
Drawer and/or door failures that may lead to a delay in access to medications. The following three situations in which drawer and/or door failures may occur have been…
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CareFusion 303, Inc. medical device recall: BD Pyxis MedStation ES Official notice ↗
Due to an automated dispensing cabinet software issue, when a medication single order contains more than one component and at least one is unavailable for a multi-item…
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CareFusion 303, Inc. medical device recall: BD Pyxis MedStation ES Official notice ↗
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…
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CareFusion 303, Inc. medical device recall: Alaris System PC Unit Model 8015 - a modular infusion pump and… Official notice ↗
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.
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CareFusion 303, Inc. medical device recall: BD Pyxis QFill Replenishment Station Official notice ↗
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…
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CareFusion 303, Inc. medical device recall: Bd Pyxis Medbank Mini Cr-2Hh-1Fh-P Official notice ↗
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…
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CareFusion 303, Inc. medical device recall: BD Pyxis: MedStation ES Official notice ↗
If automated dispensing cabinets have specific software versions, and Component Manager was configured to "installed mode", and software patch KB 5033688 was installed…
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CareFusion 303, Inc. medical device recall: BD Pyxis Official notice ↗
Multiple socket-outlet power strips that shipped with automated dispensing cabinet devices have not been certified to International Electrotechnical Commission (IEC)…
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CareFusion 303, Inc. medical device recall: BD Alaris System Manager REF: 9601 Official notice ↗
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.
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CareFusion 303, Inc. medical device recall: BD Pyxis MedStation ES Official notice ↗
Potential fluid ingress of anesthesia station or med station may result in smoke, system downtime and/or fire.
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CareFusion 303, Inc. medical device recall: BD Pyxis: MedStation ES Official notice ↗
Automated dispensing cabinets, running affected software, and Windows 10 operating system may experience the application randomly hang, freeze and/or crash, which may…
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CareFusion 303, Inc. medical device recall: BD Alaris PCU REF 8015 Official notice ↗
Alaris PCA Module 8120, Patient Controlled Analgesia infusion pump: compatible syringes labeling contains syringes that have not been validated.
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CareFusion 303, Inc. medical device recall: BD Pyxis CII Safe ES Official notice ↗
When global edit is used to update multiple formulary properties simultaneously, the following properties: 1) Require Lot Number on Recall, 2) Access Destruction Bin…
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CareFusion 303, Inc. medical device recall: BD Pyxis MedBank MedPass Software Official notice ↗
After dispensing a timed dose medication for a patient, the automated dispensing cabinet software may continue to show the already dispensed medication dose is still…
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CareFusion 303, Inc. medical device recall: BD Pyxis CII Safe Official notice ↗
Automated dispensing cabinet devices plugged into any multi-socket outlet power strips may present unacceptable levels of current leakage, which could expose users to…
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CareFusion 303, Inc. medical device recall: BD Pyxis MedStation ES Official notice ↗
Automated dispensing cabinet software is experiencing: 1) ES device download failure resulting in partial patient information loss that leads to 2) partial loss of…
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CareFusion 303, Inc. medical device recall: BD Pyxis Anesthesia ES System Official notice ↗
Automated dispensing cabinet drawer firmware may have inadvertently been downgraded to an earlier version of drawer firmware during new device installations or device…
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CareFusion 303, Inc. medical device recall: Alaris PC Unit 8015 utilizing 802.11 b/g or 802.11 a/b/g wireless… Official notice ↗
Infusion pump PCs with specific software/network cards/IP addresses can have network/wireless connection failure. Could cause inability to receive new datasets and…
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CareFusion 303, Inc. medical device recall: BD Pyxis MedBank System - Product Label/labeling pending Official notice ↗
Due to customer complaints related to the MedBank software which may indicate that a different medication is loaded in a cubie (drawer) pocket than what is physically…
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CareFusion 303, Inc. medical device recall: BD Pyxis MedBank Cabinet Software v2.1.2.9 Legacy MedBank Cabinets… Official notice ↗
The automated dispensing cabinet software update included a .dll file that is not compatible with MedBank Cabinet stations with MedCart Matrix drawers. The cabinet…
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CareFusion 303, Inc. medical device recall: BD Alaris Infusion Pump Module Model 8100 Pump Module Keypad Official notice ↗
Pump Module keypad lifting, and Fluid ingress could result in 1) Unresponsive keys: module continues infusion, PC unit will not alarm and must be used for programming…
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CareFusion 303, Inc. medical device recall: BD Alaris System Official notice ↗
The Alaris PC unit can display incorrect syringe type and/or syringe sizes. This could result in delays in infusion, under-infusion, or over-infusion.
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CareFusion 303, Inc. medical device recall: BD Alaris System PC Unit Model 8100 Official notice ↗
Pump Module keypad may exhibit keys that are unresponsive or stuck as a result of fluid ingress potentially resulting in a delay to the start of infusion or interruption…
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CareFusion 303, Inc. medical device recall: Alaris System PC Unit Model 8015 Official notice ↗
The pump module keypad may exhibit keys that are unresponsive or stuck as a result of fluid ingress potentially resulting in a delay to the start of infusion,…
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CareFusion 303, Inc. medical device recall: BD Alaris System. The EtCO2 module is a capnograph indicated for… Official notice ↗
Infusion pump component defect may result in interruption of patient monitoring
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CareFusion 303, Inc. medical device recall: Alaris Pump Module Model 8100 - Product Usage: is intended to provide… Official notice ↗
LED display, which provides infusion or patient monitoring values, on the module may have segments that appear dim.
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CareFusion 303, Inc. medical device recall: Alaris Pump Module Model 8100 Official notice ↗
Broken elements on pump module platen such as broken upper hinge post, lower hinge, and membrane frame can occur when the door is forcefully closed on an object, the…
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CareFusion 303, Inc. medical device recall: Alaris System PC Unit Model 8000 modular infusion pump and monitoring… Official notice ↗
If one or more screws or washers are loose or missing causing the battery not to be properly secured to the PC Unit, that is running on battery power, the system may…
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CareFusion 303, Inc. medical device recall: Alaris System PC Unit Model 8000 Official notice ↗
Cleaning agents may damage Inter-Unit Interface (IUI) Connectors, which may lead to interruption of communication or power between PC Unit and modules, which may result…
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CareFusion 303, Inc. medical device recall: CareFusion Alaris System Official notice ↗
1)Error 255-XX-XXX results in inability to edit settings 2)Delay options programming may result in no KVO rate/therapy interruption 3)Software errors results in no low…
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CareFusion 303, Inc. medical device recall: Alaris EtCO2 Official notice ↗
Calibration; it has been determined that the capnographs may have been calibrated during manufacturing using a lower than specified concentration of CO2
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CareFusion 303, Inc. medical device recall: Alaris Pump Official notice ↗
The bezel manufacturing process for the FR-110 plastic may have resulted in its weakening. A bezel with weakened plastic may, over time, lead to separation of the bezel…
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CareFusion 303, Inc. medical device recall: Alaris Infusion Pump administration sets labeled as: -Infusion Set… Official notice ↗
Complaints where users were unable to prime the administration set.
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CareFusion 303, Inc. medical device recall: Alaris Extension Sets with microbore tubing Model 20022 and 30914 Is… Official notice ↗
Reports of incorrect priming volume due to manufacturing with incorrect tubing.
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CareFusion 303, Inc. medical device recall: Alaris Syringe Pump Official notice ↗
The syringe plunger grippers may fail to automatically close around the syringe plunger press when the gripper control knob has been closed.
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CareFusion 303, Inc. medical device recall: Alaris Pump Module model 8100 manufactured between November 2011 and… Official notice ↗
The recalling firm has received reports of increased or decreased flows that have occurred in certain pumps.
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CareFusion 303, Inc. medical device recall: VersaSafe Plastic Cannula - 11 Gauge Official notice ↗
Punctures in blister packaging that was detected during the packaging process.
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CareFusion 303, Inc. medical device recall: Alaris Pump Module model 8100 Official notice ↗
There is a potential risk that could cause unintended flow in the older, centered sear door latch design in the Alaris Pump module model 8100.
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CareFusion 303, Inc. medical device recall: Alaris PC Unit Official notice ↗
BD initiated the recall of Alaris PC unit model 8015 after the firm identified five scenarios which can result in the occurrence of Systems Error Code 255-16-275 and can…
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CareFusion 303, Inc. medical device recall: SmartSite Add-On Bag Access Device Official notice ↗
CareFusion is recalling the SmartSite Add-On Bag Device due to reports of separation and/or leakages between the spike port and the drip chamber spike. A separation or…
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CareFusion 303, Inc. medical device recall: Alaris System PC unit Official notice ↗
Reports where the Low Battery alarm and/or the Very Low Battery alarm are not being triggered before the battery is discharged and all infusion channels are stopped.
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CareFusion 303, Inc. medical device recall: MaxGuard Extension Set Official notice ↗
CareFusion is recalling the MaxGuard Extension Set due to reports of leaks occurring with the 0.2 micron filter.
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CareFusion 303, Inc. medical device recall: MaxGuard Extension Set with Injection Site and 0.2 micron filter Official notice ↗
CareFusion is recalling the MaxGuard Extension Set with Injection Site and 0.2 micron filter because of reports of separation and/or leakages between the Y-connector and…
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CareFusion 303, Inc. medical device recall: Alaris Pump Module Official notice ↗
During an infusion, a false Air-in-Line (AIL) alarm would cause the infusion to be interrupted.
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CareFusion 303, Inc. medical device recall: Alaris Syringe Module Model 8110 with software version 9.15 The… Official notice ↗
A software anomaly with the Alaris Syringe module software version 9.15 may cause an infusion to unexpectedly stop when the Syringe module is transitioning from one rate…
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CareFusion 303, Inc. medical device recall: Alaris System PC Unit Model 8015 with software versions 9.17 and 9.19 Official notice ↗
A patient weight can be populated incorrectly under certain conditions when using the RESTORE feature to restore infusions running on the Alaris LVP module model 8100…
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CareFusion 303, Inc. medical device recall: Alaris PC unit Official notice ↗
The Alaris PC units model 8015 may display a system error code 133.6080 due to failure with the super capacitor (C245) at power up on the Alaris PC unit logic boards.
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CareFusion 303, Inc. medical device recall: Alaris PC Unit Official notice ↗
CareFusion is recalling the Alaris PC unit because a component on the PC unit power supply may cause a "System Error" or "Missing Battery" error code (120.4630).
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CareFusion 303, Inc. medical device recall: Alaris Pump VersaSafe Infusion Set Official notice ↗
CareFusion is recalling the Alaris VersaSafe Infusion Set because of separation and/or leakages at the VersaSafe split septum port and tubing may lead to leakage of the…
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CareFusion 303, Inc. medical device recall: Jadak Barcode Scanner Official notice ↗
Customers reported issues when scanning medications with the scanners. When a user scans a medication using the affected barcode scanner, information on a different…
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CareFusion 303, Inc. medical device recall: Alaris EtCO2 Module Official notice ↗
CareFusion is recalling the Alaris EtCO2 module model 8300 because it may have been tested during service using a higher than specified concentration of CO2. The effect…
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CareFusion 303, Inc. medical device recall: Alaris Pump SmartSite Infusion Set Official notice ↗
CareFusion is recalling the Alaris Pump Module SmartSite Infusion Set because the disconnection and leakage may occur during infusion.
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CareFusion 303, Inc. medical device recall: SmartSite Extension Set Official notice ↗
CareFusion is recalling the SmartSite Extension Set due to disconnection and leakage issues.
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CareFusion 303, Inc. medical device recall: Alaris Syringe Pump Official notice ↗
Channel Error code is displayed on the PC unit with an audio and visual alarm, and on the syringe module. After the error is cleared on the PCU, the syringe pump is…
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CareFusion 303, Inc. medical device recall: Alaris PC unit model 8015 Official notice ↗
An issue with the cancel functionality used during atypical infusion programming to cancel user inputted values. An infusion may start that is greater than or less than…
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CareFusion 303, Inc. medical device recall: Alaris PC units Official notice ↗
CareFusion is recalling the Alaris PC unit because of an error code. The error code may occur upon power on during the "Power-On Self Test" due to a keypad issue.
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CareFusion 303, Inc. medical device recall: SmartSite Low Sorbing Infusion Set Official notice ↗
CareFusion is recalling the SmartSite Low Sorbing Infusion set due to disconnection and leakage issues.
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CareFusion 303, Inc. medical device recall: SmartSite Low Sorbing Infusion Set Official notice ↗
CareFusion is recalling the SmartSite Low Sorbing Infusion Set because they were assembled with a drip chamber that consist of a 15 micron filter. The Directions For Use…
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CareFusion 303, Inc. medical device recall: Alaris Pump model 8100 with software version 9.1.18 and software… Official notice ↗
CareFusion is recalling the Alaris Pump model 8100 version 9.1.18 because it may have a software issue that results in situation where the pump module will not properly…
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CareFusion 303, Inc. medical device recall: SmartSite Extension Set Official notice ↗
Disconnections and leakages at the connection of the smallbore tubing and the SmartSite Y-port.
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CareFusion 303, Inc. medical device recall: SmartSite Needleless Connector Official notice ↗
CareFusion is recalling the SmartSite Needlefree Connector, model number 2000E, because of connection issues. The affected SmartSite connector lots may unintentionally…
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CareFusion 303, Inc. medical device recall: Trifurcated Extension Set Official notice ↗
CareFusion is recalling the Trifurcated Extension Set, models ME 1224 and MP 9230, because they may have a defect in the trifurcated component that could result in a…
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CareFusion 303, Inc. medical device recall: Alaris PC unit model 8000 and 8015 with Alaris PCA module model 8120… Official notice ↗
CareFusion is recalling the Alaris PC unit (model 8000 and 8015) because the Alaris PC unit will produce an audible alarm and the Alaris PC unit will display a System…
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CareFusion 303, Inc. medical device recall: SmartSite Low Sorbing Infusion Set with Texium Close Male Luer Official notice ↗
CareFusion is recalling the SmartSite Low Sorbing Infusion Set with Texium Closed Male Luer because it is not assembled with low-sorbing tubing.
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CareFusion 303, Inc. medical device recall: VersaSafe Extension Set Official notice ↗
CareFusion is recalling the VersaSafe Extension Intravascular Administration Set because it may have excessive adhesive which will prevent the male spin collar to…
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CareFusion 303, Inc. medical device recall: CareFusion Gravity Set Official notice ↗
CareFusion is recalling the Gravity Set (Model 44000-07) because of an incorrect expiration date. The affected lot numbers of the Gravity Set are labeled with a 5 year…
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CareFusion 303, Inc. medical device recall: SmartSite Low Sorbing Infusion Set Official notice ↗
CareFusion is recalling the SmartSite Low Sorbing Infusion Set, Model# 10015048, because there is a potential for separation at the tubing sleeve below the drip chamber.
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CareFusion 303, Inc. medical device recall: SmartSite Low Sorbing Infusion Set Official notice ↗
CareFusion is recalling the SmartSite Low Sorbing Infusion Set, Model 72313E, Lot Number 13016314, because of an incorrect filter was assembled on this lot. The correct…
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CareFusion 303, Inc. medical device recall: Alaris PC unit Official notice ↗
CareFusion is recalling the Alaris PC units model 8015 (PC unit), version 9.12, because it is operating at an incorrect voltage and it could potentially experience a…
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Carefusion 303 Inc medical device recall: CareFusion SmartSite Gravity Blood Set Model 42082E. Used to… Official notice ↗
CareFusion is recalling the SmartSite¿ Gravity Blood Set as a result of a potential for separation at the connection of the drip chamber and tubing . The separation may…
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CareFusion 303, Inc. medical device recall: Alaris Pump Module Model 8100 Official notice ↗
The recall was initiated because Carefusion has identified a potential risk associated with the Alaris Pump module model 8100. The pump module door keypad overlay may…
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CareFusion 303, Inc. medical device recall: Alaris Pump Module model 8100. Subsequent product code: FPA The Pump… Official notice ↗
The recall was initiated because Carefusion identified a potential risk associated with the Alaris Pump module model 8100. Carefusion has received reports of customers…
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CareFusion 303, Inc. medical device recall: Alaris PC unit model 8015 Product Usage: The device is labeled for… Official notice ↗
The recall was initiated because the Alaris PC unit model 8015 has a component on the PC unit power supply board that is causing an error code(120.4630) "System Error"…
Firm names are matched across agencies by name only. Different companies with similar names may be grouped together; check each official notice.