Recall archive
136 recalls · page 1 of 6
Reported Jul 22, 2026
BD ChloraPrep Clear, (2% w/v chlorhexidine gluconate (CHG) and 70% v/v isopropyl alcohol), 60 x 1 mL…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.CareFusion 213, LLC
Matched: Brand · Product details — Lack of Assurance of Sterility: Affected product may exhibit an open or incomplete seal on the packaging of the applicator
FDA (openFDA drug enforcement)
Reported Jul 8, 2026Updated Sep 6, 2026
BD ChloraPrep Hi-Lite Orange, (2% w/v chlorhexidine gluconate (CHG) and 70% v/v isopropyl alcohol (IPA)), packaged as…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.CareFusion 213, LLC
Matched: Brand · Product details — Lack of assurance of sterility: Unsterilized ChloraPrep & PurPrep Applicators, intended for further processing and sterilization were instead…
9 more products in this recall
FDA (openFDA drug enforcement)
Reported Jul 1, 2026
BD ChloraPrep Clear, (2% w/v chlorhexidine gluconate (CHG) and 70% v/v isopropyl alcohol (IPA) 1 mL Applicator, 60…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.CareFusion 213, LLC
Matched: Brand — Lack of Assurance of Sterility: Due to wrinkles in the paper lidding which may breach the seal area.
3 more products in this recall
FDA (openFDA drug enforcement)
Reported Jun 10, 2026
BD Pyxis MedStation 4000 REF: 303 Medication cabinet
Moderate riskThis product could cause temporary or reversible health problems — stop using it.CareFusion 303, Inc.
Matched: Brand — Fingerprint scanner may overheat to a temperature to cause 1st degree burn.
7 more products in this recall
FDA (openFDA device enforcement)
Reported May 13, 2026
BD PurPrep, Povidone-iodine 8.3% w/w (0.83% available iodine) with isopropyl alcohol 72.5% w/w Sterile Solution,…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.CareFusion 213, LLC
Matched: Brand · Product details — Lack of assurance of Sterility: potential product contamination
1 more product in this recall
FDA (openFDA drug enforcement)
Reported Apr 1, 2026
BD Alaris" System with Guardrails" Suite MX with Point of Care Unit
Moderate riskThis product could cause temporary or reversible health problems — stop using it.CareFusion 303, Inc.
Matched: Brand — Due to product labeling not indicating which Transport Layer Security (TLS) version that must be enabled on hospital network to ensure secure Wi-Fi…
FDA (openFDA device enforcement)
Reported Feb 4, 2026
BD Alaris" Pump Module model 8100 UDI-DI code: 10885403810046 The BD AlarisTM System with Guardrails" Suite MX is a…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.CareFusion 303, Inc.
Matched: Brand — Due to a number of modules flashed with a date and time associated with the daylight savings time (DST) adjustment that may cause connectivity issue…
FDA (openFDA device enforcement)
Reported Jan 14, 2026
BD Pyxis ES Enterprise Server Catalog Numbers 1115-00, 137672-02,137672-03 137671-02, 137671-03, 137670-02, 137670-03,…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.CareFusion 303, Inc.
Matched: Brand — Due a software issue that may result in equipment not receiving timely updates of patient, medication, or related information from enterprise systems.
FDA (openFDA device enforcement)
Reported Jan 7, 2026
BD ChloraPrep" Triple Swabsticks (Chlorhexidine gluconate (CHG), 2% w/v and Isopropyl alcohol (IPA), 70% v/v), 5.25 mL…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.CareFusion 213, LLC
Matched: Brand · Product details — Lack of Assurance of Sterlity
FDA (openFDA drug enforcement)
Reported Dec 31, 2025
BD Pyxis MedStation ES, REF: 323, BD Pyxis MedStation ES 7 Drawer Auxiliary, REF: 324, BD Pyxis MedStation ES Tower,…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.CareFusion 303, Inc.
Matched: Brand — Automated Dispensing Cabinets (ADC) received a Half Height CUBIE drawer firmware update, which caused a Cubie Insert event which prompts software to…
FDA (openFDA device enforcement)
Reported Nov 26, 2025
BD Alaris infusion Pump Module 8100, REF: 8100; KIT, BEZEL ASSY 8100BD, REF: 49000437; KIT ASSY ONE PIECE BEZEL 8100,…
High riskUsing this product could cause serious injury, illness or death — stop using it now.CareFusion 303, Inc.
Matched: Brand — If infusion pump is dropped or severely jarred this may damage the pump module bezel assembly, which can cause under-infusion, over-infusion,…
FDA (openFDA device enforcement)
Reported Nov 5, 2025
Various models of BD Pyxis Medbank: Reference numbers: 1137-00 1145-00 1146-00 1147-00 1148-00 138902-01 138903-01…
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.
4 more products in this recall
FDA (openFDA device enforcement)
Reported Oct 15, 2025
BD Alaris Pump Infusion Sets for the following reference numbers: C24101E, Amber Tubing, 15 Micron Filter, 0.2 Micron…
High riskUsing this product could cause serious injury, illness or death — stop using it now.CareFusion 303, Inc.
Matched: Brand — Infusion pump module used with compatible pump infusion sets may perform outside the established performance ranges for flow rate and bolus accuracy,…
FDA (openFDA device enforcement)
Reported Sep 3, 2025
BD Pyxis Product Name / UDI-DI code / Catalog No. BD Pyxis" MedStation" 4000 Main / 10885403512629 / 303 BD Pyxis"…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.CareFusion 303, Inc.
Matched: Brand — Antivirus software was not consistently installed on impacted devices during the implementation process.
FDA (openFDA device enforcement)
Reported Aug 20, 2025
Description/REF: BD PYXIS MEDBANK MINI 1FH-1FM/169-137, BD PYXIS MEDBANK MINI 4HM/169-113, BD PYXIS MEDBANK MINI…
Low riskThis product is unlikely to cause harm, but it breaks a safety or labelling rule.CareFusion 303, Inc.
Matched: Brand — Reports of delayed access to medication in automated dispensing cabinets because of the override/Add Item workflow.
FDA (openFDA device enforcement)
Reported Aug 13, 2025
BD Alaris Pump Module Model, 8100 with Guardrails, Suite MX software versions
High riskUsing this product could cause serious injury, illness or death — stop using it now.CareFusion 303, Inc.
Matched: Brand — Infusion pump module used with compatible pump infusion sets may perform outside the established performance ranges for flow rate and bolus accuracy,…
1 more product in this recall
FDA (openFDA device enforcement)
Reported Jul 2, 2025
Product Name [REF]: Supply Server, CCE Enterprise SW Site License (2-5), BD Pyxis Logistics [806], BD Pyxis MedStation…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.CareFusion 303, Inc.
Matched: Brand — During automated dispensing cabinet upgrade/installation/reimaging, component manager was left in installed mode, and if a Microsoft patch is then…
FDA (openFDA device enforcement)
Reported May 28, 2025
BD ChloraPrep Clear, 2% x/v chlorhexidine gluconate (CHG) and 70% v/v isopropyl alcohol (IPA), Patient Preoperative…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.CareFusion 213, LLC
Matched: Brand · Product details — Lack of Assurance of Sterility: The affected product may exhibit an open seal on the packaging of the applicator.
FDA (openFDA drug enforcement)
Reported Apr 30, 2025
BD PYXIS MEDBANK (Name, REF): MEDPASS MODULE, 139088-01; MINI 1FH-1FM, 169-137; MINI 1HH-1FH-1HM, 169-101; MINI…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.CareFusion 303, Inc.
Matched: Brand — Users trying to restock a single bin location of an automated dispensing cabinet, during pocket exchange restocking workflow, may experience a…
FDA (openFDA device enforcement)
Reported Apr 23, 2025
MEDFLEX, REF: 1119-00; MEDBANK MAIN, REF: 1137-00; MEDFLEX 2.0, REF: 1139-00; MEDBANK TOWER MAIN, REF: 1145-00; MEDBANK…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.CareFusion 303, Inc.
Matched: Brand — If "Clear All" selected medications is selected on patient profile, the automated dispensing cabinet may allow dispensing of medication without first…
FDA (openFDA device enforcement)
Reported Apr 16, 2025
BD Pyxis" MedBank" Mini and BD Pyxis" MedBank" Tower, BD Pyxis" MedFlex, BD Pyxis" MedBank" MedPass are automated…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.CareFusion 303, Inc.
Matched: Brand — Due to a software bug, automated dispensing cabinet is unable to calculate countback discrepancies during the issue process, which causes incorrect…
1 more product in this recall
FDA (openFDA device enforcement)
Reported Mar 26, 2025
BD Pyxis: Anesthesia Station ES, REF: 327, MedStation ES, REF: 323, MedStation ES Tower, REF: 352, CII Safe ES, REF:…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.CareFusion 303, Inc.
Matched: Brand — Sync timeout may occur between the server and automated dispensing device, due to a server software error which may occur if syncing a large amount…
FDA (openFDA device enforcement)
Reported Mar 19, 2025
BD ChloraPrep Clear 1mL Applicators, 2% w/v chlorhexidine gluconate (CHG) and 70% v/v isopropyl alcohol (IPA), Patient…
High riskUsing this product could cause serious injury, illness or death — stop using it now.CareFusion 213, LLC
Matched: Brand · Product details — Non-Sterility: contamination of Aspergillus penicillioides, due to breach in package lidding.
FDA (openFDA drug enforcement)
Reported Mar 19, 2025
BD Alaris Systems Manager , REF 9601 Infusion Safety Management Software
High riskUsing this product could cause serious injury, illness or death — stop using it now.CareFusion 303, Inc.
Matched: Brand — Software issue that may result in outdated automated programming request(APR) being sent to the progressive care unit (PCU).
1 more product in this recall
FDA (openFDA device enforcement)
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