Brand
Carefusion 303, Inc. Recalls
101 recalls on record. Search official CPSC, FDA, and USDA datasets for every recall issued for Carefusion 303, Inc..
101Total Recalls
32Critical
56.0MUnits Affected
Feb 11, 2026Most Recent
All Recalls
Every Carefusion 303, Inc. Recall
Sorted by most recent. Click any recall for full details.
101 recalls
CriticalFDA
Carefusion 303, Inc.
BD Alaris Syringe Module, REF 8110
Medical Devices133,727 affectedSep 15, 2023
High RiskFDA
Carefusion 303, Inc.
BD Pyxis MedBank MedPass Software, REF: 139088-01
Medical Devices37 affectedAug 18, 2023
High RiskFDA
Carefusion 303, Inc.
BD Pyxis MedStation ES (Med ES Main), REF: 323; and BD Pyxis MedStation ES (Med ES Main Tower), REF: 352
Medical Devices622 affectedApr 5, 2023
High RiskFDA
Carefusion 303, Inc.
BD Pyxis Med ES Auxiliary (AUX), REF 343
Medical Devices5,918 affectedFeb 14, 2023
High RiskFDA
Carefusion 303, Inc.
BD Pyxis MedStation ES AUX Tower REF 343 BD Pyxis " MedStation 4000 AUX Tower REF 314 The BD Pyxis" MedStation ES and Pyxis" MedSta...
Medical Devices27,666 affectedFeb 14, 2023
High RiskFDA
Carefusion 303, Inc.
BD Pyxis MedStation 4000 Main, REF 303
Medical Devices13,055 affectedFeb 14, 2023
High RiskFDA
Carefusion 303, Inc.
BD Pyxis Med 4000 Auxiliary (AUX), REF 314
Medical Devices5 affectedFeb 14, 2023
High RiskFDA
Carefusion 303, Inc.
BD Pyxis MedStation ES (Med ES Main), REF 323
Medical Devices94,466 affectedFeb 14, 2023
High RiskFDA
Carefusion 303, Inc.
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
Medical Devices83,185 affectedJan 24, 2023
High RiskFDA
Carefusion 303, Inc.
BD Pyxis MedBank Cabinet Software v2.1.2.9 Legacy MedBank Cabinets with Matrix Drawers include: . CUBEX MedFlex operating with Wind...
Medical Devices686 affectedMay 24, 2022
CriticalFDA
Carefusion 303, Inc.
BD Alaris Infusion Pump Module Model 8100 Pump Module Keypad; and Pump Module Door Assembly Replacement Kit with Pump Module Keypad, Part...
Medical Devices160,300 affectedMar 3, 2021
CriticalFDA
Carefusion 303, Inc.
BD Alaris System PC Unit Model 8100 (Pump Module) and Pump Module Door Assembly Replacement Kits (P/N 49000239, 49000346, 49000438, 49000...
Medical Devices248,519 affectedAug 4, 2020
CriticalFDA
Carefusion 303, Inc.
Alaris System PC Unit Model 8015
Medical Devices313,740 affectedAug 4, 2020
CriticalFDA
Carefusion 303, Inc.
BD Alaris System; Alaris Syringe Module Model 8110; BD Alaris System; Alaris PCA Module Model 8120; BD Alaris System; Syringe/PCA Siz...
Medical Devices180,186 affectedAug 4, 2020
High RiskFDA
Carefusion 303, Inc.
BD Alaris System. The EtCO2 module is a capnograph indicated for continuous, noninvasive monitoring of end tidal carbon dioxide (EtCO2), ...
Respiratory Devices680 affectedAug 4, 2020
CriticalFDA
Carefusion 303, Inc.
Alaris System PC Unit Model 8015, a modular infusion pump and monitoring system
Medical Devices824,277 affectedJun 30, 2020
CriticalFDA
Carefusion 303, Inc.
Alaris System PC Unit Model 8015. modular infusion pump and monitoring system
Medical Devices824,277 affectedJun 30, 2020
High RiskFDA
Carefusion 303, Inc.
Alaris Syringe Module Model 8110 - Product Usage: is intended to provide trained healthcare caregivers a way to automate the programming ...
Medical Devices130,612 affectedJun 30, 2020
CriticalFDA
Carefusion 303, Inc.
Alaris Pump Module Model 8100, a modular infusion pump and monitoring system
Medical Devices1,332,354 affectedJun 30, 2020
CriticalFDA
Carefusion 303, Inc.
Alaris Pump Module Model 8100
Medical Devices1,093,588 affectedJun 30, 2020
CriticalFDA
Carefusion 303, Inc.
Alaris EtCO2 Module Model 8300, a modular infusion pump and monitoring system
Medical Devices38,982 affectedJun 30, 2020
CriticalFDA
Carefusion 303, Inc.
Alaris Auto ID Module Model 8600, a modular infusion pump and monitoring system
Medical Devices17,767 affectedJun 30, 2020
CriticalFDA
Carefusion 303, Inc.
Alaris SpO2 Module Model 8210 and Model 8220, a modular infusion pump and monitoring system
Medical Devices7,854 affectedJun 30, 2020
High RiskFDA
Carefusion 303, Inc.
Alaris Pump Module Model 8100 - Product Usage: is intended to provide trained healthcare caregivers a way to automate the programming of ...
Medical Devices1,442,097 affectedJun 30, 2020
High RiskFDA
Carefusion 303, Inc.
Alaris SpO2 Module Model 8210 and Model 8220 - Product Usage: is intended to provide trained healthcare caregivers a way to automate the ...
Medical Devices8,558 affectedJun 30, 2020
CriticalFDA
Carefusion 303, Inc.
Alaris System PC Unit Model 8000, a modular infusion pump and monitoring system
Medical Devices37,141 affectedJun 30, 2020
CriticalFDA
Carefusion 303, Inc.
CareFusion Alaris System, Alaris PC unit models 8000 and 8015 (UDI: 10885403801518)
Medical Devices870,070 affectedFeb 4, 2020
CriticalFDA
Carefusion 303, Inc.
CareFusion Alaris PCA Module, Model 8120
Medical Devices83,015 affectedFeb 4, 2020
CriticalFDA
Carefusion 303, Inc.
CareFusion Alaris Pump Module, Model 8100
Medical Devices1,286,898 affectedFeb 4, 2020
CriticalFDA
Carefusion 303, Inc.
CareFusion Alaris Syringe Module, Model 8110
Medical Devices114,835 affectedFeb 4, 2020
CriticalFDA
Carefusion 303, Inc.
Alaris Pump, Model 8100, with bezel mechanical assemblies manufactured with FR-110 plastic resin. The following products are affected ...
Medical Devices607,618 affectedApr 13, 2018
High RiskFDA
Carefusion 303, Inc.
Alaris PCA Pump, Model 8120. The firm name on the label is CareFusion. The Alaris Syringe Pump module and Alaris PCA module are infus...
Medical Devices73,611 affectedNov 17, 2017
High RiskFDA
Carefusion 303, Inc.
Alaris Extension Sets with microbore tubing Model 20022 and 30914 Is used to administer fluid and medications from a syringe to the p...
Surgical Devices25,400 affectedNov 6, 2017
High RiskFDA
Carefusion 303, Inc.
Alaris Pump Module model 8100 manufactured between November 2011 and March 2012; Alaris Pump Module serviced with LVP Mechanism Sub Ass...
Medical Devices31,622 affectedAug 9, 2017
High RiskFDA
Carefusion 303, Inc.
VersaSafe Plastic Cannula - 11 Gauge, Model 9391-0200 Product Usage: Used with secondary IV sets or syringes with a female luer lock ...
Surgical Devices1,546,800 affectedJun 30, 2017
High RiskFDA
Carefusion 303, Inc.
Alaris Pump Module model 8100
Medical Devices35,940 affectedJun 12, 2017
High RiskFDA
Carefusion 303, Inc.
SmartSite Add-On Bag Access Device, Model No. 10013365
Medical Devices384,923 affectedNov 17, 2016
High RiskFDA
Carefusion 303, Inc.
Alaris System PC unit, model no. 8000 and 8015. The central programming, monitoring and power supply component for the Alaris infusion p...
Medical Devices613,800 affectedNov 1, 2016
High RiskFDA
Carefusion 303, Inc.
Alaris System PC Unit Model 8015 with software versions 9.17 and 9.19; Central programming, monitoring and power supply component for th...
Medical Devices69,693 affectedMay 12, 2016
High RiskFDA
Carefusion 303, Inc.
Alaris Pump VersaSafe Infusion Set, Model No. 2122-0007
Medical Devices5,760 affectedFeb 15, 2016
High RiskFDA
Carefusion 303, Inc.
Alaris PC Unit, Infusion Pump Model 8000, Part No. TC10005092
Medical Devices170 affectedFeb 12, 2016
High RiskFDA
Carefusion 303, Inc.
Jadak Barcode Scanner, Part No. 350587-32, 350587-41, 351377-32. Product Usage: An accessory for the Pyxis Anesthesia ES system an...
Medical Devices9,345 affectedJan 15, 2016
High RiskFDA
Carefusion 303, Inc.
Alaris Pump SmartSite Infusion Set, Model No. 2420-0500. Used to administer fluid and medications through a needle or catheter inserte...
Surgical Devices1,445,180 affectedNov 5, 2015
CriticalFDA
Carefusion 303, Inc.
Alaris Syringe Pump, Model No. 8110. Delivers fluids. Expansion of Affected Units: BOM Housing Assembly Service, Part No. 49000226...
Medical Devices68,460 affectedJul 21, 2015
High RiskFDA
Carefusion 303, Inc.
Alaris PC unit model 8015, Infusion pump. software version 9.17 Product Usage: The Alaris PC unit is the central programming, monitori...
Medical Devices63 affectedMay 13, 2015
High RiskFDA
Carefusion 303, Inc.
Alaris PC units, Model No. 8015. Infusion pump.
Medical Devices56,015 affectedMar 12, 2015
High RiskFDA
Carefusion 303, Inc.
SmartSite Needleless Connector, Model No. 2000E The SmartSite Needleless Connectors are sterile, individually packaged connectors. Th...
Medical Devices3,500,000 affectedJan 22, 2014
High RiskFDA
Carefusion 303, Inc.
Trifurcated Extension Set, model no. ME 1224. Trifurcated Extension Set, model no. MP 9230.
Medical Devices9,550 affectedJan 16, 2014