Recall archive
39 recalls · page 2 of 2
Reported Nov 12, 2014
CADD-Solis Medication Safety Software, Administrator CD, Version 3.1, REF 21-2194-0301-01. Product Usage: The…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Smiths Medical ASD, Inc.
Matched: Brand · Reason for recall — Smiths Medical has identified an issue with a single batch (Lot Number 2752712) of CADD"-Solis Medication Safety Software Administrator 3.1 CDs.…
FDA (openFDA device enforcement)
Reported Sep 3, 2014
4001PS Neonatal/Paed.Intubation Kit 2.5mm Murphy, LDS 15mm Conn Pediatric Endotracheal Intubation Kit
High riskUsing this product could cause serious injury, illness or death — stop using it now.Smiths Medical ASD, Inc.
Matched: Brand — The tube fastener on the ET Tube Holder may compress the tracheal tube when used which may cause difficulty when locking the ET Tube Holder in place…
5 more products in this recall
FDA (openFDA device enforcement)
Reported Jun 18, 2014
Portex Low Dead Space Connector with Sideport, 3.5mm Product Usage: The connector is used to attach the endotracheal…
High riskUsing this product could cause serious injury, illness or death — stop using it now.Smiths Medical ASD, Inc.
Matched: Brand — One lot of 3.0mm sized Connectors, Product Reorder No. 10035-05PS, Lot No. 2553426 were placed in packages labeled as size 3.5mm.
FDA (openFDA device enforcement)
Reported May 28, 2014
SW-2008 Snuggle Warm Sterile Cardiac Connective Warming Blanket; used with the Equator Convective Warmer, are intended…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Smiths Medical ASD, Inc.
Matched: Brand — The hose could separate from the blanket.
FDA (openFDA device enforcement)
Reported Apr 16, 2014
Smiths Medical HOTLINE¿ Fluid Warming Set L-70. Product Usage: intended for the delivery of warmed blood and…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Smiths Medical ASD, Inc.
Matched: Brand · Product · Product details — Injection port of the Set may leak blood/ IV fluids from the septum of the injection port or the septum may become dislodged.
1 more product in this recall
FDA (openFDA device enforcement)
Reported Mar 19, 2014
4040-2: Umbilical 3 mL Line Draw, Luer lock syringe (heparin concentration: 23.5 I.U. per mL) with Filter-Pro¿ device,…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Smiths Medical ASD, Inc.
Matched: Brand — issue with the plunger tip of the Portex¿ Arterial Blood Sampling Line Draw Syringes
12 more products in this recall
FDA (openFDA device enforcement)
Reported Jan 15, 2014
Jelco Smiths Medical Hypodermic Needle-Pro¿ Fixed Needle Insulin Syringe, 1.0ml 29g x 1/2 in Reference: 4429-1…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Smiths Medical ASD, Inc.
Matched: Brand · Product · Product details — Visible orange/ brown particulate on the needles of the 29g Hypodermic Needle-Pro¿ Fixed Needle Insulin Syringes
4 more products in this recall
FDA (openFDA device enforcement)
Reported Dec 25, 2013
Medfusion¿ 4000 Syringe Infusion Pumps Medfusion¿ 4000 Syringe Infusion Pumps are designed for use in care areas for…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Smiths Medical ASD, Inc.
Matched: Brand · Reason for recall — Smiths Medical is conducting a recall involving all Medfusion¿ 4000 Syringe Infusion Pumps. Smiths Medical has identified an issue with electrical…
FDA (openFDA device enforcement)
Reported Nov 13, 2013
Portex¿ Spinal Tray with Drugs 22g Whitacre/25g Whitacre; 15248C-22/25 The Regional Anesthesia family of products is…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Smiths Medical ASD, Inc.
Matched: Brand — Visual particulate in the glass ampules of 5% Lidocaine HCL and 7.5% Dextrose Injection, USP, 2 mL Ampoule, NDC # 0409-4712-01, Hospira Lot Number…
8 more products in this recall
FDA (openFDA device enforcement)
Reported Oct 2, 2013
Smith Medical, Deltec, REF 21-2386-24, 11 Fr Introducer Set with Peel-Away Sheath, Sterile EO, Rx Only PORT-A-CATH¿ and…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Smiths Medical ASD, Inc.
Matched: Brand · Product · Product details · Reason for recall — Smiths Medical is conducting a voluntary recall of PORT-A-CATH¿ and PORT-A-CATH¿ II Implantable Venous and Arterial Access Systems and Introducer…
1 more product in this recall
FDA (openFDA device enforcement)
Reported May 15, 2013
Wallace Sure-Pro/ Sure-Pro Ultra Embryo Replacement Catheters (with ultrasound) Product Code: PE623 Sure-Pro¿ Embryo…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Smiths Medical ASD, Inc.
Matched: Brand — Unable to pass catheter through outer sheath during embryo transfer
5 more products in this recall
FDA (openFDA device enforcement)
Reported Apr 10, 2013
Smiths Medical, BCI¿ Remote Alarm Cable (Normally Open & Normally Closed), Reorder Numbers: WW3398NO & WW3398NC. For…
High riskUsing this product could cause serious injury, illness or death — stop using it now.Smiths Medical ASD, Inc.
Matched: Brand · Product · Product details — In rare instances, the BCI¿ Remote Alarm Cables (BCI¿ Cable) are not transferring alarms when used with some remote nurse alarm systems.
FDA (openFDA device enforcement)
Reported Apr 3, 2013
Medfusion Model 3500 Syringe Pump, Model #3500-415 and 3500-500. Intended for use in critical care areas for the…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Smiths Medical ASD, Inc.
Matched: Brand — An issue with the plunger rod seal was identified where the seal had the potential to migrate inside the pump case top during slow rate/ high back…
FDA (openFDA device enforcement)
Reported Aug 8, 2012
Smiths Medical, Medfusion¿ Syringe Infusion Pump, Model 4000, Software Version V1.0 & V1.1, Reorder Numbers…
High riskUsing this product could cause serious injury, illness or death — stop using it now.Smiths Medical ASD, Inc.
Matched: Brand · Product · Product details · Reason for recall — Smiths Medical has identified a software anomaly in the Medfusion 4000 Syringe Infusion Pump that causes a device history log corruption and triggers…
FDA (openFDA device enforcement)
Reported Jul 18, 2012
Smiths Medical HOTLINE 3 Blood and Fluid Warmer, Reorder Numbers: HL-390 Product Usage: The Micro-switch is used on the…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Smiths Medical ASD, Inc.
Matched: Brand · Product · Product details — HOTLINE 3 Blood and Fluid Warmer( Reorder No. HL-390 ) disposable is not correctly installed , the microswitch may become damaged and unusable
FDA (openFDA device enforcement)
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