Recall archive
136 recalls · page 2 of 6
Reported Mar 5, 2025
BD Pyxis: MedFlex, REF: 1119-00; MedBank Tower REF: 1145-00; MedBank MedPass, REF: 139088-01 and associated BD Pyxis…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.CareFusion 303, Inc.
Matched: Brand — Automated dispensing device labeling is being updated to strengthen labeling around manual access to medications to address the risk of potential…
6 more products in this recall
FDA (openFDA device enforcement)
Reported Feb 19, 2025
(1) Pyxis MedStation ES, Catalog No. 323; (2) Pyxis Anesthesia Station (PAS), Catalog No. 327; (3) Pyxis MedStation ES…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.CareFusion 303, Inc.
Matched: Brand — Software issues could potentially result in: 1) delays in accessing dispensing software application, 2) wrong therapy (dose, item, timing, etc.), or…
5 more products in this recall
FDA (openFDA device enforcement)
Reported Feb 5, 2025
BD Pyxis MedStation ES AUX Tower REF 343 BD Pyxis " MedStation 4000 AUX Tower REF 314 The BD Pyxis" MedStation ES and…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.CareFusion 303, Inc.
Matched: Brand — Due to an increase in complaints of door latch assembly failures that may cause the doors to be left in an open state potentially causing inventory…
FDA (openFDA device enforcement)
Reported Jan 29, 2025
BD Pyxis MedStation ES (Med ES Main), REF 323
Moderate riskThis product could cause temporary or reversible health problems — stop using it.CareFusion 303, Inc.
Matched: Brand — Drawer and/or door failures that may lead to a delay in access to medications. The following three situations in which drawer and/or door failures…
5 more products in this recall
FDA (openFDA device enforcement)
Reported Jan 22, 2025
BD Pyxis MedStation ES (Med ES Main), REF: 323; and BD Pyxis MedStation ES (Med ES Main Tower), REF: 352
Moderate riskThis product could cause temporary or reversible health problems — stop using it.CareFusion 303, Inc.
Matched: Brand — Due to an automated dispensing cabinet software issue, when a medication single order contains more than one component and at least one is…
FDA (openFDA device enforcement)
Reported Dec 18, 2024
BD Pyxis MedStation ES, REF: 323
Moderate riskThis product could cause temporary or reversible health problems — stop using it.CareFusion 303, Inc.
Matched: Brand — Due to a software issue, automated dispensing cabinet devices may open the wrong cubie pocket or position, which can lead to: 1) Unintended and…
2 more products in this recall
FDA (openFDA device enforcement)
Reported Sep 25, 2024
Alaris System PC Unit Model 8015 - a modular infusion pump and monitoring system
Moderate riskThis product could cause temporary or reversible health problems — stop using it.CareFusion 303, Inc.
Matched: Brand — Due to affected devices that may have bent female IUI connector and may not be operable and potentially cause delays in the start of the infusion or…
4 more products in this recall
FDA (openFDA device enforcement)
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 Sep 27, 2023
BD ChloraPrep Clear, 2% w/v chlorhexidine gluconate (CHG) and 70% v/v isopropyl alcohol (IPA) Sterile Solution, 0.03mL…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.CareFusion 213, LLC
Matched: Brand · Product details — Stability data does not support expiry: Shelf-life of the impacted lots of BD ChloraPrep" Clear 1 mL Applicator cannot be substantiated beyond…
FDA (openFDA drug enforcement)
Reported Aug 23, 2023
Snowden-Pencer MIS DIAMOND-TOUCH GRASPER MCKERNAN FUNDUS 5MM, 32CM, RATCHETED, REF SP90-7012; endoscopic surgical device
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Carefusion 2200 Inc.
Matched: Brand — Specific lots of the product have the potential to exhibit cracking or breaking of the rotation knob due to the incorrect use of an adhesive in the…
14 more products in this recall
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 May 3, 2023
(1) Carefusion V. Mueller Graves Vaginal Speculum, Catalog #GL11, Medium Blade, 4 x 1 3/8" (10.2 X 3.5cm); and (2)…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Carefusion 2200 Inc.
Matched: Brand · Product · Product details — A portion of the two products were incorrectly marked (etched) and packaged resulting in a product mismatch. The labels and laser etchings were…
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 15, 2023
CD5 Series of Genesis Reusable Rigid Sterilization Container Systems catalog number and product name: 1. CD5-3B,…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Carefusion 2200 Inc.
Matched: Brand — Product did not meet shelf-life testing requirements resulting in a breach of the sterility of the Genesis container holding surgical equipment.
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)
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