Recall archive
81 recalls · page 2 of 4
Reported Sep 11, 2024
BD Pyxis QFill Replenishment Station, REF: 138904-01, medication cabinet system
Moderate riskThis product could cause temporary or reversible health problems — stop using it.CareFusion 303, Inc.
Matched: Brand — 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…
1 more product in this recall
FDA (openFDA device enforcement)
Reported Aug 14, 2024
BD PYXIS MEDBANK MINI CR-2HH-1FH-P, REF: 169-114 containing software version 3.9.1.9
Moderate riskThis product could cause temporary or reversible health problems — stop using it.CareFusion 303, Inc.
Matched: Brand — Due to software issue, there is a potential when a restock label is printed for a medication stored in automated dispensing cabinets, that the…
18 more products in this recall
FDA (openFDA device enforcement)
Reported Jul 24, 2024
BD Pyxis: MedStation ES (Main), REF: 323; MedStation ES Tower, REF: 352; Anesthesia Station ES, REF: 327; CII Safe ES,…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.CareFusion 303, Inc.
Matched: Brand — If automated dispensing cabinets have specific software versions, and Component Manager was configured to "installed mode", and software patch KB…
FDA (openFDA device enforcement)
Reported Jul 10, 2024
BD Pyxis, Name/REF: MEDBANK MINI 1FH-1FM/ 169-137, MEDBANK MINI 1FH-2HH MEDPASS/ 169-151, MEDBANK MINI 1HH-1FH-1HM/…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.CareFusion 303, Inc.
Matched: Brand — Multiple socket-outlet power strips that shipped with automated dispensing cabinet devices have not been certified to International Electrotechnical…
2 more products in this recall
FDA (openFDA device enforcement)
Reported Jun 5, 2024
BD Pyxis MedStation ES, REF: 323, Medication Cabinet
Moderate riskThis product could cause temporary or reversible health problems — stop using it.CareFusion 303, Inc.
Matched: Brand — Potential fluid ingress of anesthesia station or med station may result in smoke, system downtime and/or fire.
5 more products in this recall
FDA (openFDA device enforcement)
Reported Mar 13, 2024
BD Pyxis: MedStation ES, REF: 323; Anesthesia Station ES, REF: 327; MedStation ES Tower, REF: 352;
Moderate riskThis product could cause temporary or reversible health problems — stop using it.CareFusion 303, Inc.
Matched: Brand — Automated dispensing cabinets, running affected software, and Windows 10 operating system may experience the application randomly hang, freeze and/or…
FDA (openFDA device enforcement)
Reported Nov 15, 2023
BD Alaris PCU REF 8015
High riskUsing this product could cause serious injury, illness or death — stop using it now.CareFusion 303, Inc.
Matched: Brand — Alaris PCA Module 8120, Patient Controlled Analgesia infusion pump: compatible syringes labeling contains syringes that have not been validated.
2 more products in this recall
FDA (openFDA device enforcement)
Reported Oct 18, 2023
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…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.CareFusion 303, Inc.
Matched: Brand — When global edit is used to update multiple formulary properties simultaneously, the following properties: 1) Require Lot Number on Recall, 2) Access…
FDA (openFDA device enforcement)
Reported Oct 4, 2023
BD Pyxis MedBank MedPass Software, REF: 139088-01
Moderate riskThis product could cause temporary or reversible health problems — stop using it.CareFusion 303, Inc.
Matched: Brand — After dispensing a timed dose medication for a patient, the automated dispensing cabinet software may continue to show the already dispensed…
FDA (openFDA device enforcement)
Reported Jul 12, 2023
BD Pyxis CII Safe, Software: V7, REF: 107-96, 107-97, 107-97-201; BD Pyxis CII Safe, Software: V7, REF: 107-223,…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.CareFusion 303, Inc.
Matched: Brand — Automated dispensing cabinet devices plugged into any multi-socket outlet power strips may present unacceptable levels of current leakage, which…
FDA (openFDA device enforcement)
Reported May 17, 2023
BD Pyxis MedStation ES (Med ES Main), REF: 323; BD Pyxis MedStation ES (Med ES Main Tower), REF: 352; BD Pyxis…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.CareFusion 303, Inc.
Matched: Brand — Automated dispensing cabinet software is experiencing: 1) ES device download failure resulting in partial patient information loss that leads to 2)…
FDA (openFDA device enforcement)
Reported Mar 29, 2023
BD Pyxis Anesthesia ES System (PAS ES), REF: 327; BP Pyxis MedStation ES (Med ES Main), REF: 323; BD Pyxis MedStation…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.CareFusion 303, Inc.
Matched: Brand — Automated dispensing cabinet drawer firmware may have inadvertently been downgraded to an earlier version of drawer firmware during new device…
FDA (openFDA device enforcement)
Reported 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…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.CareFusion 303, Inc.
Matched: Brand — Infusion pump PCs with specific software/network cards/IP addresses can have network/wireless connection failure. Could cause inability to receive…
FDA (openFDA device enforcement)
Reported Jan 18, 2023
BD Pyxis MedBank System - Product Label/labeling pending
Moderate riskThis product could cause temporary or reversible health problems — stop using it.CareFusion 303, Inc.
Matched: Brand — Due to customer complaints related to the MedBank software which may indicate that a different medication is loaded in a cubie (drawer) pocket than…
FDA (openFDA device enforcement)
Reported Oct 5, 2022
BD Pyxis MedBank Cabinet Software v2.1.2.9 Legacy MedBank Cabinets with Matrix Drawers include: . CUBEX MedFlex…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.CareFusion 303, Inc.
Matched: Brand — The automated dispensing cabinet software update included a .dll file that is not compatible with MedBank Cabinet stations with MedCart Matrix…
FDA (openFDA device enforcement)
Reported Apr 7, 2021
BD Alaris Infusion Pump Module Model 8100 Pump Module Keypad; and Pump Module Door Assembly Replacement Kit with Pump…
High riskUsing this product could cause serious injury, illness or death — stop using it now.CareFusion 303, Inc.
Matched: Brand — Pump Module keypad lifting, and Fluid ingress could result in 1) Unresponsive keys: module continues infusion, PC unit will not alarm and must be…
FDA (openFDA device enforcement)
Reported Sep 16, 2020
BD Alaris System; Alaris Syringe Module Model 8110; BD Alaris System; Alaris PCA Module Model 8120; BD Alaris System;…
High riskUsing this product could cause serious injury, illness or death — stop using it now.CareFusion 303, Inc.
Matched: Brand — 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.
3 more products in this recall
FDA (openFDA device enforcement)
Reported Sep 9, 2020
BD Alaris System. The EtCO2 module is a capnograph indicated for continuous, noninvasive monitoring of end tidal carbon…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.CareFusion 303, Inc.
Matched: Brand — Infusion pump component defect may result in interruption of patient monitoring
FDA (openFDA device enforcement)
Reported Aug 26, 2020
Alaris Pump Module Model 8100 - Product Usage: is intended to provide trained healthcare caregivers a way to automate…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.CareFusion 303, Inc.
Matched: Brand — LED display, which provides infusion or patient monitoring values, on the module may have segments that appear dim.
4 more products in this recall
FDA (openFDA device enforcement)
Reported Aug 12, 2020
Alaris System PC Unit Model 8000, a modular infusion pump and monitoring system
High riskUsing this product could cause serious injury, illness or death — stop using it now.CareFusion 303, Inc.
Matched: Brand — Cleaning agents may damage Inter-Unit Interface (IUI) Connectors, which may lead to interruption of communication or power between PC Unit and…
10 more products in this recall
FDA (openFDA device enforcement)
Reported Mar 11, 2020
CareFusion Alaris System, Alaris PC unit models 8000 and 8015 (UDI: 10885403801518)
High riskUsing this product could cause serious injury, illness or death — stop using it now.CareFusion 303, Inc.
Matched: Brand · Product · Product details — 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…
3 more products in this recall
FDA (openFDA device enforcement)
Reported Sep 11, 2019
Alaris EtCO2, Model 8300, UDI: 10885403830013, CareFusion for models 11634567 and 8300ADXeN933
Moderate riskThis product could cause temporary or reversible health problems — stop using it.CareFusion 303, Inc.
Matched: Brand · Product · Product details — Calibration; it has been determined that the capnographs may have been calibrated during manufacturing using a lower than specified concentration of…
FDA (openFDA device enforcement)
Reported Jul 24, 2019
Alaris Pump, Model 8100, with bezel mechanical assemblies manufactured with FR-110 plastic resin. The following…
High riskUsing this product could cause serious injury, illness or death — stop using it now.CareFusion 303, Inc.
Matched: Brand — 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…
FDA (openFDA device enforcement)
Reported Nov 14, 2018
Alaris Infusion Pump administration sets labeled as: -Infusion Set Alaris Pump Module/Medley Pump Module/Gemini…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.CareFusion 303, Inc.
Matched: Brand · Product details — Complaints where users were unable to prime the administration set.
FDA (openFDA device enforcement)
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