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CareFusion 303, Inc. FDA Recalls
104 recalls on file across devices, 10 of them Class I and 104 still open. Matched by name to CFN.
Newest first
Class I is the FDA's most serious grade: a reasonable probability of serious harm or death.
| Product |
|---|
| BD Pyxis MedStation 4000 REF: 303 Medication cabinetClass IIApr 30, 2026Fingerprint scanner may overheat to a temperature to cause |
| BD Pyxis MedStation ES Tower REF: 352 Medication cabinetClass IIApr 30, 2026Fingerprint scanner may overheat to a temperature to cause |
| BD Pyxis MedBank Mini REF: 1147-00 Medication cabinetClass IIApr 30, 2026Fingerprint scanner may overheat to a temperature to cause |
| BD Pyxis MedBank Tower REF: 1145-00 Medication cabinetClass IIApr 30, 2026Fingerprint scanner may overheat to a temperature to cause |
| BD Pyxis Anesthesia Station 4000 REF: 338 Medication cabinetClass IIApr 30, 2026Fingerprint scanner may overheat to a temperature to cause |
| BD Pyxis Anesthesia Station ES REF: 327 Medication cabinetClass IIApr 30, 2026Fingerprint scanner may overheat to a temperature to cause |
| BD Pyxis MedStation ES REF: 323 Medication cabinetClass IIApr 30, 2026Fingerprint scanner may overheat to a temperature to cause |
| BD Pyxis Mini Main REF: 349 Medication cabinetClass IIApr 30, 2026Fingerprint scanner may overheat to a temperature to cause |
| BD Alaris" System with Guardrails" Suite MX with Point of Care UnitClass IIFeb 11, 2026Due to product labeling not indicating which Transport Layer |
| BD Pyxis ES Enterprise Server Catalog Numbers 1115-00, 137672-02,137672-03 137671-02, 137671-03, 137670-02, 137670-03, Class IIDec 3, 2025Due a software issue that may result in equipment not receiv |
| BD Pyxis MedStation ES, REF: 323, BD Pyxis MedStation ES 7 Drawer Auxiliary, REF: 324, BD Pyxis MedStation ES TowerClass IINov 20, 2025Automated Dispensing Cabinets (ADC) received a Half Height C |
| BD Alaris" Pump Module model 8100 UDI-DI code: 10885403810046 The BD AlarisTM System with Guardrails" Suite MX is a Class IINov 6, 2025Due to a number of modules flashed with a date and time asso |
| BD Alaris infusion Pump Module 8100, REF: 8100; KIT, BEZEL ASSY 8100BD, REF: 49000437; KIT ASSY ONE PIECE BEZEL 8100,Class IOct 17, 2025If infusion pump is dropped or severely jarred this may dama |
| BD Pyxis Pro MedStation Main, REF: 1155-00Class IISep 30, 2025Potential fluid ingress of anesthesia station or med station |
| Various models of BD Pyxis MedFlex, Reference numbers: 1119-00 1139-00 139038-01 139039-01 139040-01 139041-01 13Class IISep 30, 2025Potential fluid ingress of anesthesia station or med station |
| Various models of BD Pyxis Medbank: Reference numbers: 1137-00 1145-00 1146-00 1147-00 1148-00 138902-01 138903-Class IISep 30, 2025Potential fluid ingress of anesthesia station or med station |
| Various models of BD Pyxis Pro 7-Drawer Auxiliary, Reference numbers: 1149-00 and 1152-00Class IISep 30, 2025Potential fluid ingress of anesthesia station or med station |
| All Serial Numbers/BD Pyxis CII Safe ES Tower Main, REF: 1116-00Class IISep 30, 2025Potential fluid ingress of anesthesia station or med station |
| BD Alaris Pump Infusion Sets for the following reference numbers: C24101E, Amber Tubing, 15 Micron Filter, 0.2 Micron Class ISep 11, 2025Infusion pump module used with compatible pump infusion set |
| Description/REF: BD PYXIS MEDBANK MINI 1FH-1FM/169-137, BD PYXIS MEDBANK MINI 4HM/169-113, BD PYXIS MEDBANK MINI 4HHClass IIIJul 10, 2025Reports of delayed access to medication in automated dispens |
| BD Alaris Pump Infusion Sets REF: 10013186, BD Alaris Pump Infusion Set, Back Check Valve, 3 SmartSite Y-sites LVP 60Class IJul 8, 2025Infusion pump module used with compatible pump infusion set |
| BD Alaris Pump Module Model, 8100 with Guardrails, Suite MX software versionsClass IJul 8, 2025Infusion pump module used with compatible pump infusion set |
| Product Name [REF]: Supply Server, CCE Enterprise SW Site License (2-5), BD Pyxis Logistics [806], BD Pyxis MedStation 4Class IIMay 8, 2025During automated dispensing cabinet upgrade/installation/rei |
| BD Pyxis Product Name / UDI-DI code / Catalog No. BD Pyxis" MedStation" 4000 Main / 10885403512629 / 303 BD Pyxis" Class IIMay 8, 2025Antivirus software was not consistently installed on impacte |
| BD Pyxis MedBank CUBIE Replenishment Station Product / Material ID BD PYXIS MEDBANK TWR MN CR-10HH-2FM-P / 155141-01Class IIMar 11, 2025Due to a software issue, when attempting to restock the auto |
| BD Pyxis" MedBank" Mini and BD Pyxis" MedBank" Tower, BD Pyxis" MedFlex, BD Pyxis" MedBank" MedPass are automated dispenClass IIMar 11, 2025Due to a software bug, automated dispensing cabinet is unabl |
| BD PYXIS MEDBANK (Name, REF): MEDPASS MODULE, 139088-01; MINI 1FH-1FM, 169-137; MINI 1HH-1FH-1HM, 169-101; MINI 1HH-Class IIMar 11, 2025Users trying to restock a single bin location of an automate |
| BD Care Coordination Engine (CCE) Infusion Adapter, Safety Management SoftwareClass IFeb 18, 2025Software issue that may result in outdated automated program |
| BD Alaris Systems Manager , REF 9601 Infusion Safety Management SoftwareClass IFeb 18, 2025Software issue that may result in outdated automated program |
| BD Pyxis: Anesthesia Station ES, REF: 327, MedStation ES, REF: 323, MedStation ES Tower, REF: 352, CII Safe ES, REFClass IIFeb 6, 2025Sync timeout may occur between the server and automated disp |
| BD Alaris Pump Module REF 8100 The BD Alaris System with Guardrails Suite MX is a modular infusion pump and monitorinClass IIJan 23, 2025Due to User Manual/Direction for Use incorrectly instructing |
| BD Pyxis MedFlex 2.0 REF 1139-00 Bio-ID Spare Parts REF 353200-01 The BD Pyxis" MedFlex is an Automated DispensingClass IIJan 23, 2025Due to fingerprint scanner failing resulting in the scanner |
| BD Pyxis: MedFlex, REF: 1119-00; MedBank Tower REF: 1145-00; MedBank MedPass, REF: 139088-01 and associated BD Pyxis useClass IIJan 10, 2025Automated dispensing device labeling is being updated to str |
| 138913-01 BD PYXIS MEDBANK MINI CR-2HH-1FH-P 169-114 BD PYXIS MEDBANK MINI CR-2HH-1FH-P 138911-01 BD PYXIS MEDBANK MINI Class IIJan 8, 2025Labeling update to include a contraindication statement agai |
| 139088-01 BD PYXIS MEDBANK MEDPASS MODULE 169-151 BD PYXIS MEDBANK MINI 1FH-2HH MEDPASS 169-152 BD PYXIS MEDBANK MINI 2HClass IIJan 8, 2025Labeling update to include a contraindication statement agai |
| (1) BD Pyxis MedStation ES, Catalog No. 323; (2) BD Pyxis Anesthesia Station (PAS), Catalog No. 327; (3) BD Pyxis MedStaClass IIJan 8, 2025Labeling is insufficient regarding delays in access to medic |
| 155288-01 BD PYXIS MEDBANK MINI 1FH-1FM 169-137 BD PYXIS MEDBANK MINI 1FH-1FM 155311-01 BD PYXIS MEDBANK MINI 1FH-2HH 13Class IIJan 8, 2025Labeling update to include a contraindication statement agai |
| 139054-01 BD PYXIS MEDFLEX MN 1000 10HH-1FM 139055-01 BD PYXIS MEDFLEX MN 1000 12HH 139053-01 BD PYXIS MEDFLEX MN 1000 2Class IIJan 8, 2025Labeling update to include a contraindication statement agai |
| (1) Pyxis MedStation ES, Catalog No. 323; (2) Pyxis Anesthesia Station (PAS), Catalog No. 327; (3) Pyxis MedStation ESClass IIJan 8, 2025Software issues could potentially result in: 1) delays in ac |
| BD Pyxis CII Safe ES, REF: 1116-00Class IINov 14, 2024Due to a software issue, automated dispensing cabinet device |
| BD Pyxis MedStation ES 7 Drawer Auxiliary Tower, REF: 324Class IINov 14, 2024Due to a software issue, automated dispensing cabinet device |
| BD Pyxis MedStation ES, REF: 323Class IINov 14, 2024Due to a software issue, automated dispensing cabinet device |
| Alaris System PC Unit Model 8015 - a modular infusion pump and monitoring systemClass IIAug 15, 2024Due to affected devices that may have bent female IUI connec |
| Alaris Syringe Module Model 8110, a modular infusion pump and monitoring systemClass IIAug 15, 2024Due to affected devices that may have bent female IUI connec |
| Alaris EtCO2 Module Model 8300, a modular infusion pump and monitoring systemClass IIAug 15, 2024Due to affected devices that may have bent female IUI connec |
| Alaris Pump Module Model 8100, a modular infusion pump and monitoring systemClass IIAug 15, 2024Due to affected devices that may have bent female IUI connec |
| Alaris PCA Module Model 8120, a modular infusion pump and monitoring systemClass IIAug 15, 2024Due to affected devices that may have bent female IUI connec |
| BD Pyxis QFill Replenishment Station, REF: 138904-01, medication cabinet systemClass IIJul 9, 2024Due to software issue, there is a potential when a restock l |
| BKIT BD Pyxis QFill Replenishment Station, REF: 155197-01, medication cabinet systemClass IIJul 9, 2024Due to software issue, there is a potential when a restock l |
| BD PYXIS MEDBANK TWR MN CR-2HH-6FM, REF: 169-89 containing software version 3.9.1.9Class IIJun 24, 2024Due to software issue, there is a potential when a restock l |
| BD PYXIS MEDBANK TWR MN CR-14HH-P, REF: 169-86 containing software version 3.9.1.9Class IIJun 24, 2024Due to software issue, there is a potential when a restock l |
| BD PYXIS MEDBANK TWR MN CR-8HH-3FM-P, REF: 169-99 containing software version 3.9.1.9Class IIJun 24, 2024Due to software issue, there is a potential when a restock l |
| BD PYXIS MEDBANK MINI CR-2HH-1FH-P, REF: 169-114 containing software version 3.9.1.9Class IIJun 24, 2024Due to software issue, there is a potential when a restock l |
| BD PYXIS MEDBANK TWR MN CR-10HH-2FM-P, REF: 169-83 containing software version 3.9.1.9Class IIJun 24, 2024Due to software issue, there is a potential when a restock l |
| BD PYXIS MEDBANK TWR MN CR-2HH-6FH, REF: 169-88 containing software version 3.9.1.9Class IIJun 24, 2024Due to software issue, there is a potential when a restock l |
| BD PYXIS MEDBANK TWR MN CR-4HH-1FH-4FM-P, REF: 169-90 containing software version 3.9.1.9Class IIJun 24, 2024Due to software issue, there is a potential when a restock l |
| BD PYXIS MDBNK TWR MN CR-4HH-5FM-P RxNow, REF: 169-131 containing software version 3.9.1.9Class IIJun 24, 2024Due to software issue, there is a potential when a restock l |
| BD PYXIS MEDBANK TWR MN CR-4HH-5FM-P, REF: 169-91 containing software version 3.9.1.9Class IIJun 24, 2024Due to software issue, there is a potential when a restock l |
| BD PYXIS MEDBANK TWR MN CR-10HH-2FH-P, REF: 169-82 containing software version 3.9.1.9Class IIJun 24, 2024Due to software issue, there is a potential when a restock l |
| BD PYXIS MEDBANK TWR MN CR-12HH-1FH, REF: 169-84 containing software version 3.9.1.9Class IIJun 24, 2024Due to software issue, there is a potential when a restock l |
| BD PYXIS MEDBANK TWR MN CR-6HH-1FH-3FM-P, REF: 169-92 containing software version 3.9.1.9Class IIJun 24, 2024Due to software issue, there is a potential when a restock l |
| BD PYXIS MEDBANK TWR MN CR-8HH-1FH-2FM-P, REF: 169-96 containing software version 3.9.1.9Class IIJun 24, 2024Due to software issue, there is a potential when a restock l |
| BD PYXIS MEDBANK TWR MN CR-8HH-2FH-1FM-P, REF: 169-97 containing software version 3.9.1.9Class IIJun 24, 2024Due to software issue, there is a potential when a restock l |
| BD PYXIS MEDBANK TWR MN CR-6HH-4FM-P, REF: 169-94 containing software version 3.9.1.9Class IIJun 24, 2024Due to software issue, there is a potential when a restock l |
| BD PYXIS MEDBANK TWR MN CR-12HH-1FM-P, REF: 169-85 containing software version 3.9.1.9Class IIJun 24, 2024Due to software issue, there is a potential when a restock l |
| BD PYXIS MEDBANK TWR MN CR-8HH-3FH-P, REF: 169-98 containing software version 3.9.1.9Class IIJun 24, 2024Due to software issue, there is a potential when a restock l |
| BD PYXIS MEDBANK TWR MN CR-6HH-2FH-2FM-P, REF: 169-93 containing software version 3.9.1.9Class IIJun 24, 2024Due to software issue, there is a potential when a restock l |
| BD PYXIS MEDBANK MINI CR-4HH-P, REF: 169-115 containing software version 3.9.1.9Class IIJun 24, 2024Due to software issue, there is a potential when a restock l |
| BD Alaris System Manager REF: 9601, compatible with BD Alaris PC UnitsClass IIMay 21, 2024Due to a software issue the PC unit may not connect to the s |
| BD Pyxis, Name/REF: BD PYXIS MB TOWER MAIN/ 169-153, BD PYXIS MB TOWER MAIN CR/ 169-154, BD PYXIS MB TOWER MAIN W/MP/ 1Class IIMay 13, 2024Multiple socket-outlet power strips that shipped with automa |
| BD Pyxis, Name/REF: MEDBANK MINI 1FH-1FM/ 169-137, MEDBANK MINI 1FH-2HH MEDPASS/ 169-151, MEDBANK MINI 1HH-1FH-1HM/ Class IIMay 13, 2024Multiple socket-outlet power strips that shipped with automa |
| BD Pyxis: MedStation ES (Main), REF: 323; MedStation ES Tower, REF: 352; Anesthesia Station ES, REF: 327; CII Safe ESClass IIMay 2, 2024If automated dispensing cabinets have specific software vers |
| BD Pyxis" MedStation ES 7-Drawer Auxiliary Tower, REF: 324Class IIApr 15, 2024Potential fluid ingress of anesthesia station or med station |
| BD Pyxis MedStation ES, REF: 323, Medication CabinetClass IIApr 15, 2024Potential fluid ingress of anesthesia station or med station |
| BD Pyxis MedStation 4000 System, REF: 303, Medication CabinetClass IIApr 15, 2024Potential fluid ingress of anesthesia station or med station |
| BD Pyxis" Anesthesia Station ES, REF: 327Class IIApr 15, 2024Potential fluid ingress of anesthesia station or med station |
| BD Pyxis MedStation 4000 7-Drawer Auxiliary Tower, REF: 306Class IIApr 15, 2024Potential fluid ingress of anesthesia station or med station |
| BD Pyxis(TM) Anesthesia Station 4000, REF: 338Class IIApr 15, 2024Potential fluid ingress of anesthesia station or med station |
| BD Pyxis MedStation Auxiliary ES REF: 324. Intended to securely store and dispense medications to a qualified and authoClass IIFeb 23, 2024Retroactive-Due to increase in complaints, their is a potent |
| BD Pyxis MedStation Auxiliary 4000 REF: 306. Intended to securely store and dispense medications to a qualified and autClass IIFeb 23, 2024Retroactive-Due to increase in complaints, their is a potent |
| BD Pyxis MedStation ES (Med ES Main) REF: 323. Intended to securely store and dispense medications to a qualified andClass IIFeb 23, 2024Retroactive-Due to increase in complaints, their is a potent |
| BD Pyxis MedStation 4000 REF: 303. Intended to securely store and dispense medications to a qualified and authorized heClass IIFeb 23, 2024Retroactive-Due to increase in complaints, their is a potent |
| BD Pyxis: MedStation ES, REF: 323; Anesthesia Station ES, REF: 327; MedStation ES Tower, REF: 352;Class IIFeb 1, 2024Automated dispensing cabinets, running affected software, an |
| MEDFLEX, REF: 1119-00; MEDBANK MAIN, REF: 1137-00; MEDFLEX 2.0, REF: 1139-00; MEDBANK TOWER MAIN, REF: 1145-00; MEDBANK Class IIOct 5, 2023If "Clear All" selected medications is selected on patient p |
| BD Alaris Syringe Module, REF 8110Class ISep 15, 2023Alaris PCA Module 8120, Patient Controlled Analgesia infusio |
| Alaris PCA Module 8120Class ISep 15, 2023Alaris PCA Module 8120, Patient Controlled Analgesia infusio |
| BD Alaris PCU REF 8015Class ISep 15, 2023Alaris PCA Module 8120, Patient Controlled Analgesia infusio |
| BD Pyxis CII Safe ES, REF: 1116-00; and BD Pyxis : CII Safe ES Desktop PC, Wired SCNR, REF: 107-254-01; CII Safe ES DeskClass IISep 6, 2023When global edit is used to update multiple formulary proper |
| BD Pyxis MedBank MedPass Software, REF: 139088-01Class IIAug 18, 2023After dispensing a timed dose medication for a patient, the |
| BD Pyxis CII Safe, Software: V7, REF: 107-96, 107-97, 107-97-201; BD Pyxis CII Safe, Software: V7, REF: 107-223, 107-224Class IIMay 22, 2023Automated dispensing cabinet devices plugged into any multi- |
| BD Pyxis MedStation ES (Med ES Main), REF: 323; BD Pyxis MedStation ES (Med ES Main Tower), REF: 352; BD Pyxis AnesthesiClass IIApr 5, 2023Automated dispensing cabinet software is experiencing: 1) ES |
| BD Pyxis MedStation ES (Med ES Main), REF: 323; and BD Pyxis MedStation ES (Med ES Main Tower), REF: 352Class IIApr 5, 2023Due to an automated dispensing cabinet software issue, when |
| BD Pyxis MedStation 4000 Main, REF 303Class IIFeb 14, 2023Drawer and/or door failures that may lead to a delay in acce |
| BD Pyxis Med 4000 Auxiliary (AUX), REF 314Class IIFeb 14, 2023Drawer and/or door failures that may lead to a delay in acce |
| BD Pyxis Anesthesia ES System (PAS ES), REF: 327; BP Pyxis MedStation ES (Med ES Main), REF: 323; BD Pyxis MedStation ESClass IIFeb 14, 2023Automated dispensing cabinet drawer firmware may have inadve |
| BD Pyxis Med ES Auxiliary (AUX), REF 343Class IIFeb 14, 2023Drawer and/or door failures that may lead to a delay in acce |
| BD Pyxis MedStation ES (Med ES Main), REF 323Class IIFeb 14, 2023Drawer and/or door failures that may lead to a delay in acce |
| BD Pyxis MedStation ES AUX, REF 324Class IIFeb 14, 2023Drawer and/or door failures that may lead to a delay in acce |
| BD Pyxis MedStation ES AUX Tower REF 343 BD Pyxis " MedStation 4000 AUX Tower REF 314 The BD Pyxis" MedStation ES Class IIFeb 14, 2023Due to an increase in complaints of door latch assembly fail |
| BD Pyxis MedStation 4000 AUX, REF 306Class IIFeb 14, 2023Drawer and/or door failures that may lead to a delay in acce |
| 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.xClass IIJan 24, 2023Infusion pump PCs with specific software/network cards/IP ad |
| BD Pyxis MedBank System - Product Label/labeling pendingClass IIDec 12, 2022Due to customer complaints related to the MedBank software w |
| BD Pyxis MedBank Cabinet Software v2.1.2.9 Legacy MedBank Cabinets with Matrix Drawers include: . CUBEX MedFlex opClass IIMay 24, 2022The automated dispensing cabinet software update included a |
| BD Alaris Infusion Pump Module Model 8100 Pump Module Keypad; and Pump Module Door Assembly Replacement Kit with Pump MoClass IMar 3, 2021Pump Module keypad lifting, and Fluid ingress could result i |