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…
Read the official notice →- Date
- 2025-08-13
- Country
- United States
- Brand
- CareFusion
- Product
- 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;…
- Classification
- Class I
- Units
- US Nationwide Distribution to states of: AK AL AR AS AZ CA CO CT DC DE FL GA…
- Category
- Drugs & medical
- Source
- FDA · Device
Copied automatically from the US Food and Drug Administration. Details may be shortened or out of date; the official notice is the authoritative source. Disclaimer
What to do
- Check the product name, strength and lot number against the official notice.
- Do not stop a prescribed medicine without talking to your doctor or pharmacist first.
- Ask the pharmacy or supplier about a replacement or refund.
General guidance from Recall Atlas. The official notice from the US Food and Drug Administration has the exact models, batch codes and remedy, and it takes priority.
More CareFusion recalls
- 2025-10-15
USCareFusion 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 → - 2025-07-02
- 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 →
Other drugs & medical recalls in the United States
- 2025-08-13
- US
Philips Medical Systems (Cleveland) Inc recalls Pinnacle 3 with TumorLOC, (870258) Radiation Therapy Planning System Software
Due to software issue, Radiation Therapy Planning system may provide incorrect dataset calculations when performing the "Stopping Power Ratio" (SPR) ,
FDA · DevicePhilips Medical Systems (Cleveland) IncWorldwide - US Nationwide distribution in the state of WV and the countries of…Official notice → - US
Becton, Dickinson and Company, BD Bio Sciences recalls BD Trucount Controls, 30 Test - REF: 664343, RxOnly, IVD
Control kits contain incorrect standard deviation (SD) values for the low and high control beads which compromises the accurate calculation of bead counts.
FDA · DeviceBecton, Dickinson and Company, BD Bio SciencesWorldwide - US Nationwide distribution in the states of Tennessee, New York,…Official notice → - US
Flexicare Medical (Dongguan) Ltd. recalls BritePro Solo Single-Use Fiber Optic Mini Handle and Blade Ref: 040-02-0110U (Mac 1), 040-02-0120U (Mac 2), 040-02-0130U (Mac…
Laryngoscope handles may not illuminate as intended.
FDA · DeviceFlexicare Medical (Dongguan) Ltd.US Nationwide distribution in the states of WA, SD, TX, VA, PA, OK, GA, MI,…Official notice → - US
B BRAUN MEDICAL INC recalls Microbore Extension Set with 0.2 Micron Filter. Catalog Number: V6215. for use with IV tubing.
Label is incorrect. The product label indicates that the device contains an air eliminating filter. However, the filter utilized on this extension set is not indicated for removal of air and does not feature an air…
FDA · DeviceB BRAUN MEDICAL INCUS distribution to AZ, CA, CO, CT, FL, GA, HI, IL, IN, KS, MA, MD, ME, MI, MN,…Official notice → - US
ICU Medical, Inc. recalls Plum Duo Infusion System, List Number: 400020401
ICU Medical identified two sequences of programming events and alarm interactions that may cause the user interface to become unresponsive.
- US
SUN PHARMACEUTICAL INDUSTRIES INC recalls Spironolactone Tablets, USP, 25 mg, 100-count bottle, Rx only, Mfg. by: Frontida BioPharm, Inc., 1100 Orthodox St,…
Presence of foreign substance: identified as aluminum.