FDA Device Recalls

Recalls / Firms / CareFusion 303, Inc.

CareFusion 303, Inc.

166 FDA device recalls on record.

DateClassProductReason
2026-02-11BD Alaris" System with Guardrails" Suite MX with Point of Care Unit
2025-12-03BD Pyxis ES Enterprise Server Catalog Numbers 1115-00, 137672-02,137672-03 137671-02, 137671-03, 137
2025-11-20BD Pyxis MedStation ES, REF: 323, BD Pyxis MedStation ES 7 Drawer Auxiliary, REF: 324, BD Pyxis M
2025-11-06BD Alaris" Pump Module model 8100 UDI-DI code: 10885403810046 The BD AlarisTM System with Guardrail
2025-10-17BD Alaris infusion Pump Module 8100, REF: 8100; KIT, BEZEL ASSY 8100BD, REF: 49000437; KIT ASSY ONE
2025-09-30Various models of BD Pyxis Medbank: Reference numbers: 1137-00 1145-00 1146-00 1147-00 1148-00 138
2025-09-30All Serial Numbers/BD Pyxis CII Safe ES Tower Main, REF: 1116-00
2025-09-30Various models of BD Pyxis MedFlex, Reference numbers: 1119-00 1139-00 139038-01 139039-01 139040-0
2025-09-30BD Pyxis Pro MedStation Main, REF: 1155-00
2025-09-30Various models of BD Pyxis Pro 7-Drawer Auxiliary, Reference numbers: 1149-00 and 1152-00
2025-09-11BD Alaris Pump Infusion Sets for the following reference numbers: C24101E, Amber Tubing, 15 Micron
2025-07-10Description/REF: BD PYXIS MEDBANK MINI 1FH-1FM/169-137, BD PYXIS MEDBANK MINI 4HM/169-113, BD PY
2025-07-08BD Alaris Pump Infusion Sets REF: 10013186, BD Alaris Pump Infusion Set, Back Check Valve, 3 Smar
2025-07-08BD Alaris Pump Module Model, 8100 with Guardrails, Suite MX software versions
2025-05-08Product Name [REF]: Supply Server, CCE Enterprise SW Site License (2-5), BD Pyxis Logistics [806], B
2025-05-08BD Pyxis Product Name / UDI-DI code / Catalog No. BD Pyxis" MedStation" 4000 Main / 10885403512629
2025-03-11BD PYXIS MEDBANK (Name, REF): MEDPASS MODULE, 139088-01; MINI 1FH-1FM, 169-137; MINI 1HH-1FH-1HM,
2025-03-11BD Pyxis MedBank CUBIE Replenishment Station Product / Material ID BD PYXIS MEDBANK TWR MN CR-10
2025-03-11BD Pyxis" MedBank" Mini and BD Pyxis" MedBank" Tower, BD Pyxis" MedFlex, BD Pyxis" MedBank" MedPass
2025-02-18BD Care Coordination Engine (CCE) Infusion Adapter, Safety Management Software
2025-02-18BD Alaris Systems Manager , REF 9601 Infusion Safety Management Software
2025-02-06BD Pyxis: Anesthesia Station ES, REF: 327, MedStation ES, REF: 323, MedStation ES Tower, REF: 35
2025-01-23BD Pyxis MedFlex 2.0 REF 1139-00 Bio-ID Spare Parts REF 353200-01 The BD Pyxis" MedFlex is an
2025-01-23BD Alaris Pump Module REF 8100 The BD Alaris System with Guardrails Suite MX is a modular infusio
2025-01-10BD Pyxis: MedFlex, REF: 1119-00; MedBank Tower REF: 1145-00; MedBank MedPass, REF: 139088-01 and ass
2025-01-08138913-01 BD PYXIS MEDBANK MINI CR-2HH-1FH-P 169-114 BD PYXIS MEDBANK MINI CR-2HH-1FH-P 138911-01 BD
2025-01-08139054-01 BD PYXIS MEDFLEX MN 1000 10HH-1FM 139055-01 BD PYXIS MEDFLEX MN 1000 12HH 139053-01 BD PYX
2025-01-08139088-01 BD PYXIS MEDBANK MEDPASS MODULE 169-151 BD PYXIS MEDBANK MINI 1FH-2HH MEDPASS 169-152 BD P
2025-01-08(1) Pyxis MedStation ES, Catalog No. 323; (2) Pyxis Anesthesia Station (PAS), Catalog No. 327; (3)
2025-01-08155288-01 BD PYXIS MEDBANK MINI 1FH-1FM 169-137 BD PYXIS MEDBANK MINI 1FH-1FM 155311-01 BD PYXIS MED
2025-01-08(1) BD Pyxis MedStation ES, Catalog No. 323; (2) BD Pyxis Anesthesia Station (PAS), Catalog No. 327;
2024-11-14BD Pyxis MedStation ES, REF: 323
2024-11-14BD Pyxis MedStation ES 7 Drawer Auxiliary Tower, REF: 324
2024-11-14BD Pyxis CII Safe ES, REF: 1116-00
2024-08-15Alaris PCA Module Model 8120, a modular infusion pump and monitoring system
2024-08-15Alaris Syringe Module Model 8110, a modular infusion pump and monitoring system
2024-08-15Alaris System PC Unit Model 8015 - a modular infusion pump and monitoring system
2024-08-15Alaris Pump Module Model 8100, a modular infusion pump and monitoring system
2024-08-15Alaris EtCO2 Module Model 8300, a modular infusion pump and monitoring system
2024-07-09BD Pyxis QFill Replenishment Station, REF: 138904-01, medication cabinet system
2024-07-09BKIT BD Pyxis QFill Replenishment Station, REF: 155197-01, medication cabinet system
2024-06-24BD PYXIS MEDBANK TWR MN CR-6HH-4FM-P, REF: 169-94 containing software version 3.9.1.9
2024-06-24BD PYXIS MEDBANK TWR MN CR-8HH-2FH-1FM-P, REF: 169-97 containing software version 3.9.1.9
2024-06-24BD PYXIS MEDBANK TWR MN CR-2HH-6FH, REF: 169-88 containing software version 3.9.1.9
2024-06-24BD PYXIS MEDBANK TWR MN CR-8HH-3FM-P, REF: 169-99 containing software version 3.9.1.9
2024-06-24BD PYXIS MEDBANK TWR MN CR-6HH-1FH-3FM-P, REF: 169-92 containing software version 3.9.1.9
2024-06-24BD PYXIS MEDBANK MINI CR-2HH-1FH-P, REF: 169-114 containing software version 3.9.1.9
2024-06-24BD PYXIS MEDBANK TWR MN CR-6HH-2FH-2FM-P, REF: 169-93 containing software version 3.9.1.9
2024-06-24BD PYXIS MEDBANK TWR MN CR-4HH-1FH-4FM-P, REF: 169-90 containing software version 3.9.1.9
2024-06-24BD PYXIS MEDBANK TWR MN CR-14HH-P, REF: 169-86 containing software version 3.9.1.9
2024-06-24BD PYXIS MEDBANK TWR MN CR-4HH-5FM-P, REF: 169-91 containing software version 3.9.1.9
2024-06-24BD PYXIS MEDBANK MINI CR-4HH-P, REF: 169-115 containing software version 3.9.1.9
2024-06-24BD PYXIS MEDBANK TWR MN CR-8HH-3FH-P, REF: 169-98 containing software version 3.9.1.9
2024-06-24BD PYXIS MEDBANK TWR MN CR-12HH-1FH, REF: 169-84 containing software version 3.9.1.9
2024-06-24BD PYXIS MEDBANK TWR MN CR-10HH-2FM-P, REF: 169-83 containing software version 3.9.1.9
2024-06-24BD PYXIS MDBNK TWR MN CR-4HH-5FM-P RxNow, REF: 169-131 containing software version 3.9.1.9
2024-06-24BD PYXIS MEDBANK TWR MN CR-2HH-6FM, REF: 169-89 containing software version 3.9.1.9
2024-06-24BD PYXIS MEDBANK TWR MN CR-10HH-2FH-P, REF: 169-82 containing software version 3.9.1.9
2024-06-24BD PYXIS MEDBANK TWR MN CR-12HH-1FM-P, REF: 169-85 containing software version 3.9.1.9
2024-06-24BD PYXIS MEDBANK TWR MN CR-8HH-1FH-2FM-P, REF: 169-96 containing software version 3.9.1.9
2024-05-21BD Alaris System Manager REF: 9601, compatible with BD Alaris PC Units
2024-05-13BD Pyxis, Name/REF: MEDBANK MINI 1FH-1FM/ 169-137, MEDBANK MINI 1FH-2HH MEDPASS/ 169-151, MEDBANK M
2024-05-13BD Pyxis, Name/REF: BD PYXIS MB TOWER MAIN/ 169-153, BD PYXIS MB TOWER MAIN CR/ 169-154, BD PYXIS M
2024-05-02BD Pyxis: MedStation ES (Main), REF: 323; MedStation ES Tower, REF: 352; Anesthesia Station ES, REF:
2024-04-15BD Pyxis" Anesthesia Station ES, REF: 327
2024-04-15BD Pyxis(TM) Anesthesia Station 4000, REF: 338
2024-04-15BD Pyxis MedStation 4000 System, REF: 303, Medication Cabinet
2024-04-15BD Pyxis" MedStation ES 7-Drawer Auxiliary Tower, REF: 324
2024-04-15BD Pyxis MedStation 4000 7-Drawer Auxiliary Tower, REF: 306
2024-04-15BD Pyxis MedStation ES, REF: 323, Medication Cabinet
2024-02-23BD Pyxis MedStation Auxiliary ES REF: 324. Intended to securely store and dispense medications to a
2024-02-23BD Pyxis MedStation ES (Med ES Main) REF: 323. Intended to securely store and dispense medication
2024-02-23BD Pyxis MedStation 4000 REF: 303. Intended to securely store and dispense medications to a qualifi
2024-02-23BD Pyxis MedStation Auxiliary 4000 REF: 306. Intended to securely store and dispense medications to
2024-02-01BD Pyxis: MedStation ES, REF: 323; Anesthesia Station ES, REF: 327; MedStation ES Tower, REF: 352;
2023-10-05MEDFLEX, REF: 1119-00; MEDBANK MAIN, REF: 1137-00; MEDFLEX 2.0, REF: 1139-00; MEDBANK TOWER MAIN, RE
2023-09-15BD Alaris Syringe Module, REF 8110
2023-09-15BD Alaris PCU REF 8015
2023-09-15Alaris PCA Module 8120
2023-09-06BD Pyxis CII Safe ES, REF: 1116-00; and BD Pyxis : CII Safe ES Desktop PC, Wired SCNR, REF: 107-254-
2023-08-18BD Pyxis MedBank MedPass Software, REF: 139088-01
2023-05-22BD Pyxis CII Safe, Software: V7, REF: 107-96, 107-97, 107-97-201; BD Pyxis CII Safe, Software: V7, R
2023-04-05BD Pyxis MedStation ES (Med ES Main), REF: 323; BD Pyxis MedStation ES (Med ES Main Tower), REF: 352
2023-04-05BD Pyxis MedStation ES (Med ES Main), REF: 323; and BD Pyxis MedStation ES (Med ES Main Tower), RE
2023-02-14BD Pyxis Med ES Auxiliary (AUX), REF 343
2023-02-14BD Pyxis MedStation 4000 AUX, REF 306
2023-02-14BD Pyxis MedStation 4000 Main, REF 303
2023-02-14BD Pyxis MedStation ES AUX Tower REF 343 BD Pyxis " MedStation 4000 AUX Tower REF 314 The BD P
2023-02-14BD Pyxis Anesthesia ES System (PAS ES), REF: 327; BP Pyxis MedStation ES (Med ES Main), REF: 323; BD
2023-02-14BD Pyxis MedStation ES AUX, REF 324
2023-02-14BD Pyxis Med 4000 Auxiliary (AUX), REF 314
2023-02-14BD Pyxis MedStation ES (Med ES Main), REF 323
2023-01-24Alaris PC Unit 8015 utilizing 802.11 b/g or 802.11 a/b/g wireless network cards, with IP addresses f
2022-12-12BD Pyxis MedBank System - Product Label/labeling pending
2022-05-24BD Pyxis MedBank Cabinet Software v2.1.2.9 Legacy MedBank Cabinets with Matrix Drawers include: .
2021-03-03BD Alaris Infusion Pump Module Model 8100 Pump Module Keypad; and Pump Module Door Assembly Replacem
2020-08-04BD Alaris System PC Unit Model 8100 (Pump Module) and Pump Module Door Assembly Replacement Kits (P/
2020-08-04BD Alaris System; Alaris Syringe Module Model 8110; BD Alaris System; Alaris PCA Module Model 8120
2020-08-04BD Alaris System. The EtCO2 module is a capnograph indicated for continuous, noninvasive monitoring
2020-08-04PC Unit Front Case with Keypad Replacement Kits: TC10008389 ASSY CASE FRONT W/KEYPAD 8015LS, TC10010
2020-08-04Alaris System PC Unit Model 8015
2020-06-30Alaris Auto ID Module Model 8600, a modular infusion pump and monitoring system
2020-06-30Alaris System PC Unit Model 8000, a modular infusion pump and monitoring system
2020-06-30Alaris Syringe Module Model 8110 - Product Usage: is intended to provide trained healthcare caregive
2020-06-30Alaris PCA Module Model 8120, a modular infusion pump and monitoring system
2020-06-30Alaris System PC Unit Model 8000 modular infusion pump and monitoring system
2020-06-30Alaris System PC Unit Model 8015, a modular infusion pump and monitoring system
2020-06-30Alaris SpO2 Module Model 8210 and Model 8220 - Product Usage: is intended to provide trained healthc
2020-06-30Alaris Syringe Module Model 8110, a modular infusion pump and monitoring system
2020-06-30Alaris PCA Module Model 8120 - Product Usage: is intended to provide trained healthcare caregivers a
2020-06-30Alaris Pump Module Model 8100, a modular infusion pump and monitoring system
2020-06-30Alaris Pump Module Model 8100
2020-06-30Alaris System PC Unit Model 8015. modular infusion pump and monitoring system
2020-06-30Alaris SpO2 Module Model 8210 and Model 8220, a modular infusion pump and monitoring system
2020-06-30Alaris EtCO2 Module Model 8300, a modular infusion pump and monitoring system
2020-06-30Alaris Pump Module Model 8100 - Product Usage: is intended to provide trained healthcare caregivers
2020-06-30Alaris EtCO2 Module Model 8300 - Product Usage: is intended to provide trained healthcare caregivers
2020-02-04CareFusion Alaris System, Alaris PC unit models 8000 and 8015 (UDI: 10885403801518)
2020-02-04CareFusion Alaris PCA Module, Model 8120
2020-02-04CareFusion Alaris Pump Module, Model 8100
2020-02-04CareFusion Alaris Syringe Module, Model 8110
2019-07-01Alaris EtCO2, Model 8300, UDI: 10885403830013, CareFusion for models 11634567 and 8300ADXeN933
2018-04-20Alaris Infusion Pump administration sets labeled as: -Infusion Set Alaris Pump Module/Medley Pump Mo
2018-04-13Alaris Pump, Model 8100, with bezel mechanical assemblies manufactured with FR-110 plastic resin. T
2017-11-17Alaris Syringe Pump, Model 8110. The firm name on the label is CareFusion. The Alaris Syringe Pump
2017-11-17Alaris PCA Pump, Model 8120. The firm name on the label is CareFusion. The Alaris Syringe Pump mod
2017-11-06Alaris Extension Sets with microbore tubing Model 20022 and 30914 Is used to administer fluid and
2017-08-09Alaris Pump Module model 8100 manufactured between November 2011 and March 2012; Alaris Pump Module
2017-06-30VersaSafe Plastic Cannula - 11 Gauge, Model 9391-0200 Product Usage: Used with secondary IV sets or
2017-06-12Alaris Pump Module model 8100
2017-06-12Alaris PC Unit, Model 8015
2017-02-20MaxGuard Extension Set with Injection Site and 0.2 micron filter, Model No. ME3305
2017-02-20MaxGuard Extension Set, Model No. ME2064, MP9009C, MP9209, MP9254C The MaxGuard extension sets are u
2016-12-02Alaris Pump Module, Model No. 8100 and AIL sensor kits, P/N 147083-102 and P/N 49000221. The Alaris
2016-11-17SmartSite Add-On Bag Access Device, Model No. 10013365
2016-11-01Alaris System PC unit, model no. 8000 and 8015. The central programming, monitoring and power suppl
2016-08-08Alaris Syringe Module Model 8110 with software version 9.15 The Alaris Syringe Pump module is part
2016-05-12Alaris System PC Unit Model 8015 with software versions 9.17 and 9.19; Central programming, monitori
2016-03-24Alaris PC unit, Model 8015 The Alaris PC unit is the central programming, monitoring and power supp
2016-02-15Alaris Pump VersaSafe Infusion Set, Model No. 2122-0007
2016-02-12Alaris PC Unit, Infusion Pump Model 8000, Part No. TC10005092
2016-01-15Jadak Barcode Scanner, Part No. 350587-32, 350587-41, 351377-32. Product Usage: An accessory for
2015-11-12Alaris EtCO2 Module, Model 8300. A capnograph that continuously monitors end tidal carbon dioxide (
2015-11-05Alaris Pump SmartSite Infusion Set, Model No. 2420-0500. Used to administer fluid and medications t
2015-10-09SmartSite Extension Set, Model No. 20029E. Used to administer fluid and medications through a needle
2015-07-21Alaris Syringe Pump, Model No. 8110. Delivers fluids. Expansion of Affected Units: BOM Housing As
2015-05-13Alaris PC unit model 8015, Infusion pump. software version 9.17 Product Usage: The Alaris PC unit i
2015-03-12Alaris PC units, Model No. 8015. Infusion pump.
2015-01-13SmartSite Low Sorbing Infusion Set, Model No. 10015862 The SmartSite Infusion Sets are used to admin
2014-06-17SmartSite Low Sorbing Infusion Set, Model Codes: 10014855A, 10015861A, 10061661A 14035457 14035
2014-04-23Alaris Pump model 8100 with software version 9.1.18 and software upgrade kits with "Delay Until" Opt
2014-03-19SmartSite Extension Set, Model No. 20029E, intravascular administration set.
2014-01-22SmartSite Needleless Connector, Model No. 2000E The SmartSite Needleless Connectors are sterile, i
2014-01-16Trifurcated Extension Set, model no. ME 1224. Trifurcated Extension Set, model no. MP 9230.
2013-12-05Alaris PC unit model 8000 and 8015 with Alaris PCA module model 8120 and Auto ID barcode scanner mod
2013-11-08VersaSafe Extension Set, Model No. 21000M-007
2013-11-08SmartSite Low Sorbing Infusion Set with Texium Close Male Luer, Model No. 24301-0007T The SmartSite
2013-08-30SmartSite Low Sorbing Infusion Set, Model#72313E The SmartSite Low Sorbing Infusion Sets are used t
2013-08-30CareFusion Gravity Set, Model #44000-07 The CareFusion Gravity Sets are used to administer fluid an
2013-08-30SmartSite Low Sorbing Infusion Set, Model# 10015048. Intravascular administration set.
2013-06-17Alaris PC unit, model 8015, with version 9.12-Keyboard Processor and logic board assembly part numbe
2012-06-29Alaris Pump Module model 8100. Subsequent product code: FPA The Pump module is intended for facili
2012-06-15Alaris Pump Module Model 8100 (formerly Medley Pump Module) Subsequent Product Code: FPA. The Pump
2012-05-25Alaris PC unit model 8015 Product Usage: The device is labeled for prescription use only.
2011-09-13Alaris PC unit model 8015. The Alaris PC unit is the central programming, monitoring and power supp
2011-04-20MaxPlus bifuse extension set (minibore) needleless connectors, Model Number: MP9232-C Product Usag