CareFusion recalls
64 official recalls and safety alerts involving CareFusion since 2022-04, from FDA · Device, FDA · Drug. Newest first. Check the official notice for exact models and batch codes.
This list only includes recalls Recall Atlas has collected since 2021-10. A product not listed here may still be affected; check with CareFusion or the relevant agency.
- 2026-07-22
USCareFusion 213, LLC recalls BD ChloraPrep Clear, (2% w/v chlorhexidine gluconate (CHG) and 70% v/v isopropyl alcohol), 60 x 1 mL applicators/carton, 0.03fl oz (1 mL)…
Lack of Assurance of Sterility: Affected product may exhibit an open or incomplete seal on the packaging of the applicator
- 2026-07-08
- US
CareFusion 213, LLC recalls BD ChloraPrep Hi-Lite Orange, (2% w/v chlorhexidine gluconate (CHG) and 70% v/v isopropyl alcohol (IPA)), packaged as a) 100 x 10.5 mL…
Lack of assurance of sterility: Unsterilized ChloraPrep & PurPrep Applicators, intended for further processing and sterilization were instead distributed to customers outside of the intended distribution channel
- 2026-07-01
- US
CareFusion 213, LLC recalls BD ChloraPrep FREPP Clear,(2% w/v chlorhexidine gluconate (CHG) and 70% v/v isopropyl alcohol (IPA)) 1.5 mL Applicator, 20 Applicators,…
Non-Sterility: Due to presence of Aspergillus penicillioides. And Lack of Assurance of Sterility: Due to wrinkles in the paper lidding which may breach the seal area.
FDA · DrugCareFusion 213, LLCNationwide inthe USA, as well as other foreign distribution.Official notice → - US
CareFusion 213, LLC recalls BD ChloraPrep Clear (2% w/v chlorhexidine gluconate (CHG) and 70% v/v isopropyl alcohol (IPA)), 1 mL Applicator, 60 Applicators per inner…
Non-Sterility: Due to presence of Aspergillus penicillioides.
FDA · DrugCareFusion 213, LLCNationwide inthe USA, as well as other foreign distribution.Official notice → - US
CareFusion 213, LLC recalls BD ChloraPrep Clear, (2% w/v chlorhexidine gluconate (CHG) and 70% v/v isopropyl alcohol (IPA) 1 mL Applicator, 60 Applicators, Sterile…
Lack of Assurance of Sterility: Due to wrinkles in the paper lidding which may breach the seal area.
FDA · DrugCareFusion 213, LLCNationwide inthe USA, as well as other foreign distribution.Official notice → - 2026-06-10
- US
CareFusion 303, Inc. recalls BD Pyxis MedBank Tower REF: 1145-00 Medication cabinet
Fingerprint scanner may overheat to a temperature to cause 1st degree burn.
FDA · DeviceCareFusion 303, Inc.US: Nationwide OUS: AE, AU, BE, BH, BR, CA, CL, ES, GB, IT, KW, MA, MX, NZ,…Official notice → - 2026-05-13
- US
CareFusion 213, LLC recalls BD PurPrep, Povidone-iodine 8.3% w/w (0.83% available iodine) with isopropyl alcohol 72.5% w/w Sterile Solution, 0.36 fl. oz. (10.5 mL) x…
Lack of assurance of Sterility: potential product contamination
- 2026-04-01
- US
CareFusion 303, Inc. recalls BD Alaris" System with Guardrails" Suite MX with Point of Care Unit
Due to product labeling not indicating which Transport Layer Security (TLS) version that must be enabled on hospital network to ensure secure Wi-Fi communication with Point-of-Care Units
FDA · DeviceCareFusion 303, Inc.Worldwide distribution: U.S.(Nationwide) to states of: AL, AR, AZ, CA, CO, CT,…Official notice → - 2026-02-04
- US
CareFusion 303, Inc. recalls BD Alaris" Pump Module model 8100 UDI-DI code: 10885403810046 The BD AlarisTM System with Guardrails" Suite MX is a modular infusion pump…
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 with hospital networks. This issue only affects the Interoperability…
FDA · DeviceCareFusion 303, Inc.U.S. Nationwide distribution in the states of AZ, IN, OH, and VA.Official notice → - 2026-01-14
- US
CareFusion 303, Inc. recalls BD Pyxis ES Enterprise Server Catalog Numbers 1115-00, 137672-02,137672-03 137671-02, 137671-03, 137670-02, 137670-03, 139676-01,…
Due a software issue that may result in equipment not receiving timely updates of patient, medication, or related information from enterprise systems.
FDA · DeviceCareFusion 303, Inc.Worldwide - U.S. Nationwide distribution including in the states of AK,AL,AR,…Official notice → - 2026-01-07
- US
- 2025-12-31
- US
CareFusion 303, Inc. recalls BD Pyxis MedStation ES, REF: 323, BD Pyxis MedStation ES 7 Drawer Auxiliary, REF: 324, BD Pyxis MedStation ES Tower, REF: 352, BD Pyxis…
Automated Dispensing Cabinets (ADC) received a Half Height CUBIE drawer firmware update, which caused a Cubie Insert event which prompts software to generate a duplicate address, which causes an error and the drawer to…
FDA · DeviceCareFusion 303, Inc.Worldwide - US Nationwide distribution including in the states of CO, IN, OH,…Official notice → - 2025-11-26
- US
CareFusion 303, Inc. recalls BD Alaris infusion Pump Module 8100, REF: 8100; KIT, BEZEL ASSY 8100BD, REF: 49000437; KIT ASSY ONE PIECE BEZEL 8100, REF: 49000270. Used…
If infusion pump is dropped or severely jarred this may damage the pump module bezel assembly, which can cause under-infusion, over-infusion, unregulated flow, or pump module failure to calibrate; so dropped/jarred…
FDA · DeviceCareFusion 303, Inc.Worldwide distribution. US nationwide including Puerto Rico, Guam, American…Official notice → - 2025-11-05
- US
CareFusion 303, Inc. recalls BD Pyxis Pro MedStation Main, REF: 1155-00
Potential fluid ingress of anesthesia station or med station may result in smoke, system downtime and/or fire.
FDA · DeviceCareFusion 303, Inc.Worldwide distribution - US Nationwide and the countries of Canada, United…Official notice → - 2025-10-15
- US
CareFusion 303, Inc. recalls BD Alaris Pump Infusion Sets for the following reference numbers: C24101E, Amber Tubing, 15 Micron Filter, 0.2 Micron Filter, SmartSite…
Infusion pump module used with compatible pump infusion sets may perform outside the established performance ranges for flow rate and bolus accuracy, downstream and upstream occlusion time to alarm, and post-occlusion…
FDA · DeviceCareFusion 303, Inc.US: Nationwide OUS: United Arab Emirates Australia Belgium Bahrain Botswana…Official notice → - 2025-09-03
- US
CareFusion 303, Inc. recalls BD Pyxis Product Name / UDI-DI code / Catalog No. BD Pyxis" MedStation" 4000 Main / 10885403512629 / 303 BD Pyxis" MedStation" ES Tower /…
Antivirus software was not consistently installed on impacted devices during the implementation process.
FDA · DeviceCareFusion 303, Inc.Worldwide - U.S Nationwide distribution including in the states of AK, AL, AR,…Official notice → - 2025-08-20
- US
CareFusion 303, Inc. recalls Description/REF: BD PYXIS MEDBANK MINI 1FH-1FM/169-137, BD PYXIS MEDBANK MINI 4HM/169-113, BD PYXIS MEDBANK MINI 4HH/169-112, BD PYXIS…
Reports of delayed access to medication in automated dispensing cabinets because of the override/Add Item workflow.
FDA · DeviceCareFusion 303, Inc.US Nationwide distribution including in the states of NY, MA, KY, VA, OR, OH,…Official notice → - 2025-08-13
- US
CareFusion 303, Inc. recalls BD Alaris Pump Infusion Sets REF: 10013186, BD Alaris Pump Infusion Set, Back Check Valve, 3 SmartSite Y-sites LVP 60D DEHP FREE 3SS CV;…
Infusion pump module used with compatible pump infusion sets may perform outside the established performance ranges for flow rate and bolus accuracy, downstream and upstream occlusion time to alarm, and post-occlusion…
FDA · DeviceCareFusion 303, Inc.US Nationwide Distribution to states of: AK AL AR AS AZ CA CO CT DC DE FL GA…Official notice → - 2025-07-02
- US
CareFusion 303, Inc. recalls Product Name [REF]: Supply Server, CCE Enterprise SW Site License (2-5), BD Pyxis Logistics [806], BD Pyxis MedStation 4000 Main…
During automated dispensing cabinet upgrade/installation/reimaging, component manager was left in installed mode, and if a Microsoft patch is then installed this may lead to an error preventing user access to the…
FDA · DeviceCareFusion 303, Inc.Worldwide - US Nationwide distribution including in the states of PR, DE, GU,…Official notice → - 2025-05-28
- US
CareFusion 213, LLC recalls BD ChloraPrep Clear, 2% x/v chlorhexidine gluconate (CHG) and 70% v/v isopropyl alcohol (IPA), Patient Preoperative Skin Preparation,…
Lack of Assurance of Sterility: The affected product may exhibit an open seal on the packaging of the applicator.
- 2025-04-30
- US
CareFusion 303, Inc. recalls BD PYXIS MEDBANK (Name, REF): MEDPASS MODULE, 139088-01; MINI 1FH-1FM, 169-137; MINI 1HH-1FH-1HM, 169-101; MINI 1HH-1HM-1FM, 169-102; MINI…
Users trying to restock a single bin location of an automated dispensing cabinet, during pocket exchange restocking workflow, may experience a software issue that results in 2 destock transactions and 2 stock…
FDA · DeviceCareFusion 303, Inc.US Nationwide distribution including in the states of MO, MI, FL, PA, SC, OR,…Official notice → - 2025-04-23
- US
CareFusion 303, Inc. recalls MEDFLEX, REF: 1119-00; MEDBANK MAIN, REF: 1137-00; MEDFLEX 2.0, REF: 1139-00; MEDBANK TOWER MAIN, REF: 1145-00; MEDBANK MINI MAIN, REF:…
If "Clear All" selected medications is selected on patient profile, the automated dispensing cabinet may allow dispensing of medication without first requiring the RxVerify Validation Code be entered/without validation…
FDA · DeviceCareFusion 303, Inc.US Nationwide distribution in the states of KS, TX, CA, PA, NJ, FL, IN, AZ,…Official notice → - 2025-04-16
- US
CareFusion 303, Inc. recalls BD Pyxis MedBank CUBIE Replenishment Station Product / Material ID BD PYXIS MEDBANK TWR MN CR-10HH-2FM-P / 155141-01 BD PYXIS MEDBANK TWR…
Due to a software issue, when attempting to restock the automated dispensing cabinet, user have received the banner message "Stocking window has passed, or item has been removed from purchase order. Please contact…
FDA · DeviceCareFusion 303, Inc.U.S.: AL,AZ, CA, CT, FL, GA, IA, IL, IN, KS, KY, MA, MD, ME, MI, MN, MO, MS,…Official notice → - US
CareFusion 303, Inc. recalls BD Pyxis" MedBank" Mini and BD Pyxis" MedBank" Tower, BD Pyxis" MedFlex, BD Pyxis" MedBank" MedPass are automated dispensing cabinets…
Due to a software bug, automated dispensing cabinet is unable to calculate countback discrepancies during the issue process, which causes incorrect transaction quantity to be recorded. This bug can also result in the…
FDA · DeviceCareFusion 303, Inc.US Nationwide distribution: CA, TX, WI, CO, AK, VA, TN, WA, NC, NY, MS, FL,…Official notice → - 2025-03-26
- US
CareFusion 303, Inc. recalls BD Pyxis: Anesthesia Station ES, REF: 327, MedStation ES, REF: 323, MedStation ES Tower, REF: 352, CII Safe ES, REF: 1116-00, CII Safe ES…
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 of data that takes excessive time, which may cause the dispensing…
FDA · DeviceCareFusion 303, Inc.Worldwide - US Nationwide distribution including in the states of KY, OH, NY,…Official notice → - 2025-03-19
- US
CareFusion 303, Inc. recalls BD Alaris Systems Manager , REF 9601 Infusion Safety Management Software
Software issue that may result in outdated automated programming request(APR) being sent to the progressive care unit (PCU).
FDA · DeviceCareFusion 303, Inc.US: AZ, CA, DC, FL, GA, IL, IN, MI, MO, NC, NJ, NY, OH, OR, PA, SC, TX, UT,…Official notice → - US
CareFusion 213, LLC recalls BD ChloraPrep Clear 1mL Applicators, 2% w/v chlorhexidine gluconate (CHG) and 70% v/v isopropyl alcohol (IPA), Patient Preoperative Skin…
Non-Sterility: contamination of Aspergillus penicillioides, due to breach in package lidding.
- 2025-03-05
- US
CareFusion 303, Inc. recalls BD Alaris Pump Module REF 8100 The BD Alaris System with Guardrails Suite MX is a modular infusion pump and monitoring system for the…
Due to User Manual/Direction for Use incorrectly instructing user to leave the safety clamp in the open position when reloading an infusion set. This issue potentially could result in an accidental over infusion if the…
FDA · DeviceCareFusion 303, Inc.U.S.: AK, AL, AR, AZ, CA, CO, CT, DC, DE, FL, GA, GU, HI, IA, ID, IL, IN, KS,…Official notice → - US
CareFusion 303, Inc. recalls 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 CR-4HH-P 169-115…
Labeling update to include a contraindication statement against the use of medicine cabinets in procedure and operating rooms.
FDA · DeviceCareFusion 303, Inc.US Nationwide distribution including in the states of AK, AL, AR, AZ, CA, CO,…Official notice → - US
CareFusion 303, Inc. recalls BD Pyxis MedFlex 2.0 REF 1139-00 Bio-ID Spare Parts REF 353200-01 The BD Pyxis" MedFlex is an Automated Dispensing Cabinet (ADC) intended…
Due to fingerprint scanner failing resulting in the scanner heating up.
FDA · DeviceCareFusion 303, Inc.Worldwide - U.S. Nationwide distribution including in the states of AL, AZ,…Official notice → - US
CareFusion 303, Inc. recalls BD Pyxis: MedFlex, REF: 1119-00; MedBank Tower REF: 1145-00; MedBank MedPass, REF: 139088-01 and associated BD Pyxis user/software/safety…
Automated dispensing device labeling is being updated to strengthen labeling around manual access to medications to address the risk of potential delays in retrieving contents/ accessing medications that may result…
FDA · DeviceCareFusion 303, Inc.US Nationwide distribution including in the states of AZ, FL, NJ, KY, GA, CA,…Official notice → - 2025-02-19
- US
CareFusion 303, Inc. recalls BD Pyxis MedStation 4000 REF: 303. Intended to securely store and dispense medications to a qualified and authorized healthcare provider.
Retroactive-Due to increase in complaints, their is a potential for drawer and/or door failures of the medication cabinet which could result in delay in accessing medications.
FDA · DeviceCareFusion 303, Inc.US: Nationwide OUS:JP IT IN DE GB KR NL TW ES BE AU BH CA BR NZ FR AR QA MX CL…Official notice → - US
CareFusion 303, Inc. recalls (1) BD Pyxis MedStation ES, Catalog No. 323; (2) BD Pyxis Anesthesia Station (PAS), Catalog No. 327; (3) BD Pyxis MedStation ES Tower,…
Labeling is insufficient regarding delays in access to medication. The firm is strengthening the label as an additional risk mitigation.
FDA · DeviceCareFusion 303, Inc.Domestic distribution nationwide US. International distribution to North…Official notice → - US
CareFusion 303, Inc. recalls (1) Pyxis MedStation ES, Catalog No. 323; (2) Pyxis Anesthesia Station (PAS), Catalog No. 327; (3) Pyxis MedStation ES Tower, Catalog No.…
Software issues could potentially result in: 1) delays in accessing dispensing software application, 2) wrong therapy (dose, item, timing, etc.), or 3) unauthorized access and/or compliance related issues
FDA · DeviceCareFusion 303, Inc.Domestic distribution nationwide. International distribution to North America,…Official notice → - 2025-02-05
- US
CareFusion 303, Inc. recalls BD Pyxis MedStation ES AUX Tower REF 343 BD Pyxis " MedStation 4000 AUX Tower REF 314 The BD Pyxis" MedStation ES and Pyxis" MedStation…
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 discrepancies, a delay in access to medication and/or diversion of…
FDA · DeviceCareFusion 303, Inc.U.S.: AK, AL, AR, AZ, CA, CO, CT, DC, DE, FL, GA, GU, HI, IA, ID, IL, IN, KS,…Official notice → - 2025-01-29
- US
CareFusion 303, Inc. recalls BD Pyxis Med ES Auxiliary (AUX), REF 343
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 may occur have been identified: Situation 1: Door Latch Failure,…
- 2025-01-22
- US
CareFusion 303, Inc. recalls BD Pyxis MedStation ES (Med ES Main), REF: 323; and BD Pyxis MedStation ES (Med ES Main Tower), REF: 352
Due to an automated dispensing cabinet software issue, when a medication single order contains more than one component and at least one is unavailable for a multi-item or combination order, the order may display as…
FDA · DeviceCareFusion 303, Inc.US Nationwide distribution in the states of NY, NC, LA.Official notice → - 2024-12-18
- US
CareFusion 303, Inc. recalls BD Pyxis CII Safe ES, REF: 1116-00
Due to a software issue, automated dispensing cabinet devices may open the wrong cubie pocket or position, which can lead to: 1) Unintended and incorrect medication removal, or 2) Potential for a different medication…
FDA · DeviceCareFusion 303, Inc.Worldwide - US Nationwide distribution including in the states of OK, LA, FL,…Official notice → - 2024-09-25
- US
CareFusion 303, Inc. recalls Alaris EtCO2 Module Model 8300, a modular infusion pump and monitoring system
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 monitoring.
FDA · DeviceCareFusion 303, Inc.Worldwide - U.S. Nationwide distribution including in the states of AK, AL,…Official notice → - 2024-09-11
- US
CareFusion 303, Inc. recalls BKIT BD Pyxis QFill Replenishment Station, REF: 155197-01, medication cabinet system
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 for the medication is printed on the label.
FDA · DeviceCareFusion 303, Inc.US Nationwide distribution in the states of CA, FL, KS, MN, NJ, NY, PA.Official notice → - 2024-08-14
- US
CareFusion 303, Inc. recalls BD PYXIS MDBNK TWR MN CR-4HH-5FM-P RxNow, REF: 169-131 containing software version 3.9.1.9
Due to software issue, there is a potential when a restock label is printed for a medication stored in automated dispensing cabinets, that the incorrect bin for the medication is printed on the label.
FDA · DeviceCareFusion 303, Inc.US Nationwide distribution including in the states of AL, AZ, CA, CO, CT, FL,…Official notice → - 2024-07-24
- US
CareFusion 303, Inc. recalls BD Pyxis: MedStation ES (Main), REF: 323; MedStation ES Tower, REF: 352; Anesthesia Station ES, REF: 327; CII Safe ES, REF: 1116-00; CII…
If automated dispensing cabinets have specific software versions, and Component Manager was configured to "installed mode", and software patch KB 5033688 was installed in the production environment, then this will will…
FDA · DeviceCareFusion 303, Inc.Worldwide - US Nationwide distribution including in the states of OR, KS, NE,…Official notice → - 2024-07-10
- US
CareFusion 303, Inc. recalls BD Alaris System Manager REF: 9601, compatible with BD Alaris PC Units
Due to a software issue the PC unit may not connect to the server which could impact wireless data transmission to and from the server.
FDA · DeviceCareFusion 303, Inc.US Nationwide distribution including in the states of AL, AR, AZ, CA, CO, CT…Official notice → - US
CareFusion 303, Inc. recalls BD Pyxis, Name/REF: MEDBANK MINI 1FH-1FM/ 169-137, MEDBANK MINI 1FH-2HH MEDPASS/ 169-151, MEDBANK MINI 1HH-1FH-1HM/ 169-101, MEDBANK MINI…
Multiple socket-outlet power strips that shipped with automated dispensing cabinet devices have not been certified to International Electrotechnical Commission (IEC) electrical standards when used as a system with…
FDA · DeviceCareFusion 303, Inc.US Nationwide distribution including in the states of NY, CA, MO, AZ, CO, KS,…Official notice → - 2024-06-05
- US
CareFusion 303, Inc. recalls BD Pyxis(TM) Anesthesia Station 4000, REF: 338
Potential fluid ingress of anesthesia station or med station may result in smoke, system downtime and/or fire.
FDA · DeviceCareFusion 303, Inc.Worldwide - US Nationwide distribution including in the states of AK, AL, AR,…Official notice → - 2024-03-13
- US
CareFusion 303, Inc. recalls BD Pyxis: MedStation ES, REF: 323; Anesthesia Station ES, REF: 327; MedStation ES Tower, REF: 352;
Automated dispensing cabinets, running affected software, and Windows 10 operating system may experience the application randomly hang, freeze and/or crash, which may result in delays in medication access, and…
FDA · DeviceCareFusion 303, Inc.Worldwide distribution - US Nationwide distribution including in the states of…Official notice → - 2023-11-15
- US
CareFusion 303, Inc. recalls Alaris PCA Module 8120
Alaris PCA Module 8120, Patient Controlled Analgesia infusion pump: compatible syringes labeling contains syringes that have not been validated.
FDA · DeviceCareFusion 303, Inc.Worldwide Distribution: US (nationwide): AK, AL, AR, AS, AZ, CA, CO, DC, DE,…Official notice → - 2023-10-18
- US
CareFusion 303, Inc. recalls 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 Desktop PC, W-LESS…
When global edit is used to update multiple formulary properties simultaneously, the following properties: 1) Require Lot Number on Recall, 2) Access Destruction Bin (Witness), 3) Add to Destruction Bin (Count/Empty),…
FDA · DeviceCareFusion 303, Inc.US Nationwide distribution in the states of LA, NC, NY, MI, MA, NV, KS, IA, CA.Official notice → - 2023-10-04
- US
CareFusion 303, Inc. recalls BD Pyxis MedBank MedPass Software, REF: 139088-01
After dispensing a timed dose medication for a patient, the automated dispensing cabinet software may continue to show the already dispensed medication dose is still available for dispense, which could lead to…
- 2023-09-27
- US
CareFusion 213, LLC recalls BD ChloraPrep Clear, 2% w/v chlorhexidine gluconate (CHG) and 70% v/v isopropyl alcohol (IPA) Sterile Solution, 0.03mL (1 ml) each, 60…
Stability data does not support expiry: Shelf-life of the impacted lots of BD ChloraPrep" Clear 1 mL Applicator cannot be substantiated beyond 12-months although labeled with 36-month expiry. Stability studies indicate…
FDA · DrugCareFusion 213, LLCDistributed nationwide to 100 consignees. Please refer to consignee list.Official notice → - 2023-08-23
- US
Carefusion 2200 Inc recalls Snowden-Pencer MIS DIAMOND-TOUCH CLAMP BOWEL 50 MM JAW 5MM, 32CM, RATCHETED, REF SP90-7045; endoscopic surgical device
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 manufacturing process.
- 2023-07-12
- US
CareFusion 303, Inc. recalls BD Pyxis CII Safe, Software: V7, REF: 107-96, 107-97, 107-97-201; BD Pyxis CII Safe, Software: V7, REF: 107-223, 107-224, 111-191,…
Automated dispensing cabinet devices plugged into any multi-socket outlet power strips may present unacceptable levels of current leakage, which could expose users to system downtime and/or potential electric shock.
FDA · DeviceCareFusion 303, Inc.US Nationwide-Worldwide Distribution: CO, MS, HI, FL, GA, CA, ND, GU, DE, MO,…Official notice → - 2023-05-17
- US
CareFusion 303, Inc. recalls BD Pyxis MedStation ES (Med ES Main), REF: 323; BD Pyxis MedStation ES (Med ES Main Tower), REF: 352; BD Pyxis Anesthesia Station ES, REF:…
Automated dispensing cabinet software is experiencing: 1) ES device download failure resulting in partial patient information loss that leads to 2) partial loss of patient transaction data, seen as a server upload…
FDA · DeviceCareFusion 303, Inc.US Nationwide distribution in the states of KS, NY, NC, LA, MA, MI.Official notice → - 2023-05-03
- US
Carefusion 2200 Inc recalls (1) Carefusion V. Mueller Graves Vaginal Speculum, Catalog #GL11, Medium Blade, 4 x 1 3/8" (10.2 X 3.5cm); and (2) Carefusion V. Mueller…
A portion of the two products were incorrectly marked (etched) and packaged resulting in a product mismatch. The labels and laser etchings were switched on the two products.
FDA · DeviceCarefusion 2200 IncDistribution was made to AL, AR, AZ, CA, CO, CT, FL, HI, IA, IL, IN, KY, LA,…Official notice → - 2023-03-29
- US
CareFusion 303, Inc. recalls BD Pyxis Anesthesia ES System (PAS ES), REF: 327; BP Pyxis MedStation ES (Med ES Main), REF: 323; BD Pyxis MedStation ES Tower (Med ES…
Automated dispensing cabinet drawer firmware may have inadvertently been downgraded to an earlier version of drawer firmware during new device installations or device replacement upgrades, which may lead to an…
FDA · DeviceCareFusion 303, Inc.Worldwide - US Nationwide distribution including in the states of NY, PA, OH,…Official notice → - 2023-03-15
- US
Carefusion 2200 Inc recalls CD5 Series of Genesis Reusable Rigid Sterilization Container Systems catalog number and product name: 1. CD5-3B, CONTAINER SHALLOW LG ENDO…
Product did not meet shelf-life testing requirements resulting in a breach of the sterility of the Genesis container holding surgical equipment.
FDA · DeviceCarefusion 2200 IncWorldwide distribution - US Nationwide, including Puerto Rico. There was also…Official notice → - 2023-03-08
- US
CareFusion 303, Inc. recalls 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.x.x.255
Infusion pump PCs with specific software/network cards/IP addresses can have network/wireless connection failure. Could cause inability to receive new datasets and inability to transfer retrospective analytics data to…
FDA · DeviceCareFusion 303, Inc.US: FL, CA, OR, IL, WI, NJ, AZ, NV, CO, WY, NE, TX, MI, VA, OH, NC, LA, NM,…Official notice → - 2023-01-18
- US
CareFusion 303, Inc. recalls BD Pyxis MedBank System - Product Label/labeling pending
Due to customer complaints related to the MedBank software which may indicate that a different medication is loaded in a cubie (drawer) pocket than what is physically loaded and listed on the pocket label. As a result…
FDA · DeviceCareFusion 303, Inc.U.S. Nationwide distribution including in the states of AK, AL, AZ, CA, CO,…Official notice → - 2022-12-14
- US
Carefusion 2200 Inc recalls CareFusion V. Mueller TITANIUM ROUND HANDLE BAYONET BIPOLAR FORCEPS, 0.7MM TIP OVERALL LENGTH 9-1/2" (240MM) , REF F-5008
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FDA · DeviceCarefusion 2200 IncNationwide, Austria, Canada, Egypt, Germany, Hong Kong, Israel, Philippines,…Official notice → - US
Carefusion 2200 Inc recalls Carefusion V. Mueller" CUSHING BAYONET BIPOLAR FORCEPS, 2.0MM TIP, INSULATED OVERALL LENGTH 7-1/2" (190MM), REF F-2004
BD has determined that the Instructions For Use (IFU) provided by BD is missing certain content that is contained in the manufacturer's IFU. This missing content is related to the interface with the device power…
FDA · DeviceCarefusion 2200 IncNationwide, Austria, Canada, Egypt, Germany, Hong Kong, Israel, Philippines,…Official notice → - 2022-11-23
- US
Carefusion 2200 Inc recalls CareFusion V.Mueller GENESIS FULL-LENGTH CONTAINER 23 X12" (58.4 X 30.5CM) 6" (15.2CM) DEEP STERRAD COMPATIBLE, REF CD3-6ST
Genesis STERRAD Reusable Rigid Sterilization Containers have not consistently met the requirements for aerosol challenge testing.
FDA · DeviceCarefusion 2200 IncUS and Australia, Bahrain, Canada, Denmark, Hong Kong, Italy, Japan, Malaysia,…Official notice → - 2022-10-05
- US
CareFusion 303, Inc. recalls BD Pyxis MedBank Cabinet Software v2.1.2.9 Legacy MedBank Cabinets with Matrix Drawers include: . CUBEX MedFlex operating with Windows 7 .…
The automated dispensing cabinet software update included a .dll file that is not compatible with MedBank Cabinet stations with MedCart Matrix drawers. The cabinet system will stop functioning (Matrix drawers will stop…
FDA · DeviceCareFusion 303, Inc.U.S. Nationwide distribution including in the states of AL, AR, AZ, CA, CO,…Official notice → - 2022-09-28
- US
CAREFUSION recalls BD MaxGuard Drop Administration set with 3 Needleless Y-Sites Removable 3-port Manifold and removable 4-way stopcock, REF: MX4436
Administration set, and extension set product labels list expiration year 2027 but the labels should list expiration year 2025. If expired product is used, the integrity of the product may be compromised, and may…
FDA · DeviceCAREFUSIONUS: TN, FL, LA, VA, MI, OH, NC, WA, UT, TX, NV, AL, AR, IA, MA, CO, NY, SC,…Official notice → - 2022-04-06
- US
Carefusion 2200 Inc recalls (a) CareFusion Snowden-Pencer Plastics, Endoplastic Endoscope 10 mm, 30 degrees 7", 17.5 cm, Catalog #88-5910; (b) CareFusion…
The finished device package did not contain the IFU.
FDA · DeviceCarefusion 2200 IncWorldwide distribution - US Nationwide distribution in the states of AL, AZ,…Official notice →