Recall archive
136 recalls · page 3 of 6
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 Dec 14, 2022
CareFusion V. Mueller CUSHING BAYONET BIPOLAR INSULATED FORCEPS, 0.7MM TIP OVERALL LENGTH 7-1/2" (190MM) , REF F-1000
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Carefusion 2200 Inc.
Matched: Brand · Product · Product details — 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…
44 more products in this recall
FDA (openFDA device enforcement)
Reported Nov 23, 2022
CareFusion V.Mueller GENESIS MINI CONTAINER 10-1/2 X 7-1/2" (26.7X19.0CM) 3" (7.6CM) DEEP STERRAD COMPATIBLE, REF…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Carefusion 2200 Inc.
Matched: Brand · Product · Product details — Genesis STERRAD Reusable Rigid Sterilization Containers have not consistently met the requirements for aerosol challenge testing.
16 more products in this recall
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 Sep 28, 2022
BD MaxGuard Extension Set with 4-way stopcock, REF: M4058
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Carefusion
Matched: Brand — Administration set, and extension set product labels list expiration year 2027 but the labels should list expiration year 2025. If expired product is…
8 more products in this recall
FDA (openFDA device enforcement)
Reported Apr 6, 2022
(a) CareFusion Snowden-Pencer Plastics, Endoplastic Endoscope 10 mm, 30 degrees 7", 17.5 cm, Catalog #88-5910; (b)…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Carefusion 2200 Inc.
Matched: Brand · Product · Product details — The finished device package did not contain the IFU.
FDA (openFDA device enforcement)
Reported Oct 27, 2021
Catalog # BEK4511, Qty: 10, Ecomomy Jamshidi Bone Marrow Biopsy and Aspiration Tray, 11 G X 4"Biopsy/Aspiration needle,…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Bard Peripheral Vascular Inc.
Matched: Product details — Due to misbranded products shipped to customers.
1 more product in this recall
FDA (openFDA device enforcement)
Reported Sep 22, 2021
BD Extension Set SMALLBORE Tubing with 2 SmartSite VALVES, REF: 20019E
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Carefusion
Matched: Brand — Needle-free connector valves, either standalone or attached to extension sets, may have issues including difficulty to flush, flow issues, and…
14 more products in this recall
FDA (openFDA device enforcement)
Reported Jul 7, 2021
MaxPlusTM bi fuse extension set with 2 clear needleless connectors - Product Usage: The needleless connector can be…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Carefusion
Matched: Brand — A portion of a validation lot was inadvertently released to the US Market. The product did not meet the validation testing criteria regarding leakage.
FDA (openFDA device enforcement)
Reported May 19, 2021
BD ChloraPrep Hi-Lite Orange 26 mL Applicator (2% w/v chlorhexidine gluconate (CHG) and 70% v/v Isopropyl alcohol…
High riskUsing this product could cause serious injury, illness or death — stop using it now.CareFusion 213, LLC
Matched: Brand · Product details — Defective Delivery System: An increase in complaints identified endcap being loose or falling off upon activation releasing glass shards containing…
FDA (openFDA drug enforcement)
Reported May 5, 2021
BD ChloraPrep Clear, 2% w/v chlorhexidine gluconate (CHG) and 70% v/v isopropyl alcohol (IPA) Sterile Solution, 0.10…
High riskUsing this product could cause serious injury, illness or death — stop using it now.CareFusion 213, LLC
Matched: Brand · Product details — Non-sterility.Product is being recalled because at labeled storage conditions of 30*C/75% Relative Humidity, growth of Aspergillus penicillioides, a…
7 more products in this recall
FDA (openFDA drug enforcement)
Reported Apr 19, 2021
Tenacore LLC recalls Tenacore LLC 2001 Tenacore Replacement CareFusion Alaris 8100 bezels due to Potentially weakened plastic
Risk not classifiedThe agency has not ranked the risk yet — treat the notice as a caution.Tenacore LLC
Matched: Product · Product details — Potentially weakened plastic
FDA (recalls & safety alerts)
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 Mar 3, 2021
BD ChloraPrep Clear, 2% w/v chlorhexidine gluconate (CHG) and 70% v/v isopropyl alcohol (IPA) Sterile Solution, 0.10…
High riskUsing this product could cause serious injury, illness or death — stop using it now.CareFusion 213, LLC
Matched: Brand · Product details — Non-sterility: Product is being recalled to climatic Zone IV regions of the world where at the labeled storage conditions of 30*C/75% Relative…
3 more products in this recall
FDA (openFDA drug 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
BD ChloraPrep Clear 3 mL Applicators (2% w/v chlorhexidine gluconate (CHG) and 70% v/v isopropyl alcohol (IPA)) Sterile…
High riskUsing this product could cause serious injury, illness or death — stop using it now.CareFusion 213, LLC
Matched: Brand · Product details — Non-Sterility: Product is being recalled due to presence of Aspergillus Penicilloides
2 more products in this recall
FDA (openFDA drug 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 Jul 29, 2020
Thora-Para 5 Fr Non-Valved Catheter Drainage Tray
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Carefusion 2200 Inc.
Matched: Brand — The Universal Drainage Set (UDS) may contain valves that leak internally which may result in the introduction of up to 30cc of air into the patient.
13 more products in this recall
FDA (openFDA device enforcement)
Reported Jun 24, 2020
Mueller Knife Handle, Hexagonal - Product Usage: Intended to hold surgical blades.
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Carefusion 2200 Inc.
Matched: Brand — Becton Dickinson and Company, is conducting a voluntary recall on the V. MuellerTM 3H Knife Handles catalog number listed in the table above. BD has…
FDA (openFDA device enforcement)
Reported May 6, 2020
CareFusion Safe-T-Centesis Catheter Drainage Tray, Sterile, For Single Use Only, Rx only, Catalog Number PIG1280T, UDI…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Becton Dickinson & Company
Matched: Product · Product details — The 8 Fr catheter was manufactured with the 6.9 Fr needle instead of the 8 Fr needle.
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 Oct 16, 2019
CareFusion MaxPlus Clear Needleless Connector. Intended for Positive Displacement Connector for needleless access to…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Becton Dickinson & Company
Matched: Product · Product details — After disconnection of a luer, the valve of the connector remains recessed; not fully closing, either temporarily or permanently. The risks of blood…
8 more products in this recall
FDA (openFDA device enforcement)
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