CareFusion 303, Inc.
106 recalls on record · Latest: Jan 14, 2026
FDA Devices Moderate Jun 5, 2024
BD Pyxis(TM) Anesthesia Station 4000, REF: 338
FDA Devices Moderate Jun 5, 2024
BD Pyxis" Anesthesia Station ES, REF: 327
FDA Devices Moderate Jun 5, 2024
BD Pyxis MedStation 4000 System, REF: 303, Medication Cabinet
FDA Devices Moderate Mar 13, 2024
BD Pyxis: MedStation ES, REF: 323; Anesthesia Station ES, REF: 327; MedStation ES Tower, REF: 352;
FDA Devices Critical Nov 15, 2023
Alaris PCA Module 8120
FDA Devices Critical Nov 15, 2023
BD Alaris Syringe Module, REF 8110
FDA Devices Moderate Oct 4, 2023
BD Pyxis MedBank MedPass Software, REF: 139088-01
FDA Devices Moderate Mar 8, 2023
Alaris PC Unit 8015 utilizing 802.11 b/g or 802.11 a/b/g wireless network cards, with IP addresses from x.x.x.224 to x.x.x.255
FDA Devices Moderate Oct 5, 2022
BD Pyxis MedBank Cabinet Software v2.1.2.9 Legacy MedBank Cabinets with Matrix Drawers include: . CUBEX MedFlex operating with Windows 7 . Me…
FDA Devices Critical Apr 7, 2021
BD Alaris Infusion Pump Module Model 8100 Pump Module Keypad; and Pump Module Door Assembly Replacement Kit with Pump Module Keypad, Parts: 49000239;…
FDA Devices Critical Sep 16, 2020
BD Alaris System PC Unit Model 8100 (Pump Module) and Pump Module Door Assembly Replacement Kits (P/N 49000239, 49000346, 49000438, 49000439) infusio…
FDA Devices Critical Sep 16, 2020
Alaris System PC Unit Model 8015
FDA Devices Critical Sep 16, 2020
BD Alaris System; Alaris Syringe Module Model 8110; BD Alaris System; Alaris PCA Module Model 8120; BD Alaris System; Syringe/PCA Sizer Sensor Re…
FDA Devices Moderate Sep 9, 2020
BD Alaris System. The EtCO2 module is a capnograph indicated for continuous, noninvasive monitoring of end tidal carbon dioxide (EtCO2), fractional i…
FDA Devices Moderate Aug 26, 2020
Alaris Syringe Module Model 8110 - Product Usage: is intended to provide trained healthcare caregivers a way to automate the programming of infusion …
FDA Devices Moderate Aug 26, 2020
Alaris Pump Module Model 8100 - Product Usage: is intended to provide trained healthcare caregivers a way to automate the programming of infusion par…
FDA Devices Moderate Aug 26, 2020
Alaris SpO2 Module Model 8210 and Model 8220 - Product Usage: is intended to provide trained healthcare caregivers a way to automate the programming …
FDA Devices Critical Aug 12, 2020
Alaris System PC Unit Model 8015, a modular infusion pump and monitoring system
FDA Devices Critical Aug 12, 2020
Alaris System PC Unit Model 8015. modular infusion pump and monitoring system
FDA Devices Critical Aug 12, 2020
Alaris Pump Module Model 8100, a modular infusion pump and monitoring system
FDA Devices Critical Aug 12, 2020
Alaris Pump Module Model 8100
FDA Devices Critical Aug 12, 2020
Alaris EtCO2 Module Model 8300, a modular infusion pump and monitoring system
FDA Devices Critical Aug 12, 2020
Alaris Auto ID Module Model 8600, a modular infusion pump and monitoring system
FDA Devices Critical Aug 12, 2020
Alaris SpO2 Module Model 8210 and Model 8220, a modular infusion pump and monitoring system
FDA Devices Critical Aug 12, 2020
Alaris System PC Unit Model 8000, a modular infusion pump and monitoring system
FDA Devices Critical Aug 12, 2020
Alaris PCA Module Model 8120, a modular infusion pump and monitoring system
FDA Devices Critical Mar 11, 2020
CareFusion Alaris System, Alaris PC unit models 8000 and 8015 (UDI: 10885403801518)
FDA Devices Critical Mar 11, 2020
CareFusion Alaris PCA Module, Model 8120
FDA Devices Critical Mar 11, 2020
CareFusion Alaris Pump Module, Model 8100
FDA Devices Critical Mar 11, 2020
CareFusion Alaris Syringe Module, Model 8110
FDA Devices Critical Jul 24, 2019
Alaris Pump, Model 8100, with bezel mechanical assemblies manufactured with FR-110 plastic resin. The following products are affected by this reca…
FDA Devices Moderate Nov 14, 2018
Alaris Infusion Pump administration sets labeled as: -Infusion Set Alaris Pump Module/Medley Pump Module/Gemini Infusion Pump, REF 10011301, CareFu…
FDA Devices Moderate Jun 13, 2018
Alaris Extension Sets with microbore tubing Model 20022 and 30914 Is used to administer fluid and medications from a syringe to the patient throu…
FDA Devices Moderate Jan 17, 2018
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 mod…
FDA Devices Moderate Oct 25, 2017
Alaris Pump Module model 8100 manufactured between November 2011 and March 2012; Alaris Pump Module serviced with LVP Mechanism Sub Assembly (P/N) …
FDA Devices Moderate Aug 23, 2017
VersaSafe Plastic Cannula - 11 Gauge, Model 9391-0200 Product Usage: Used with secondary IV sets or syringes with a female luer lock adapter to a…
FDA Devices Moderate Jul 19, 2017
Alaris Pump Module model 8100
FDA Devices Moderate May 3, 2017
SmartSite Add-On Bag Access Device, Model No. 10013365
FDA Devices Moderate Mar 29, 2017
Alaris System PC unit, model no. 8000 and 8015. The central programming, monitoring and power supply component for the Alaris infusion pump System.
FDA Devices Moderate Jul 6, 2016
Alaris System PC Unit Model 8015 with software versions 9.17 and 9.19; Central programming, monitoring and power supply component for the Alaris Sys…
FDA Devices Moderate Mar 30, 2016
Alaris PC Unit, Infusion Pump Model 8000, Part No. TC10005092
FDA Devices Moderate Mar 23, 2016
Alaris Pump VersaSafe Infusion Set, Model No. 2122-0007
FDA Devices Moderate Feb 24, 2016
Jadak Barcode Scanner, Part No. 350587-32, 350587-41, 351377-32. Product Usage: An accessory for the Pyxis Anesthesia ES system and Pyxis Anes…
FDA Devices Moderate Dec 30, 2015
Alaris Pump SmartSite Infusion Set, Model No. 2420-0500. Used to administer fluid and medications through a needle or catheter inserted into the p…
FDA Devices Critical Aug 26, 2015
Alaris Syringe Pump, Model No. 8110. Delivers fluids. Expansion of Affected Units: BOM Housing Assembly Service, Part No. 49000226, and Lower …
FDA Devices Moderate Jun 24, 2015
Alaris PC unit model 8015, Infusion pump. software version 9.17 Product Usage: The Alaris PC unit is the central programming, monitoring and power…
FDA Devices Moderate Apr 1, 2015
Alaris PC units, Model No. 8015. Infusion pump.
FDA Devices Moderate Feb 11, 2015
SmartSite Low Sorbing Infusion Set, Model No. 10015862 The SmartSite Infusion Sets are used to administer fluid and medications through a needle or …
FDA Devices Moderate Jul 16, 2014
SmartSite Low Sorbing Infusion Set, Model Codes: 10014855A, 10015861A, 10061661A 14035457 14035485 14046894 14035458
FDA Devices Moderate Feb 12, 2014