Recall archive
49 recalls · page 2 of 3
Reported Feb 27, 2019
Check-Flo Performer Introducer, Catalog Number RCFW-5.0-25-45-RB-CHB, GPN G11571
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Cook Inc.
Matched: Brand — The products were manufactured with longer than specified sheaths.
FDA (openFDA device enforcement)
Reported Aug 22, 2018
VentriClear Ventricular Drainage Catheter Set, Cat. No. N-VVDC-01-ABRM Product Usage: The VentriClear Ventricular…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Cook Inc.
Matched: Brand — This lot of VentriClear failed endotoxin testing. Potential adverse events include immune responses ranging from non-specific febrile reaction to…
FDA (openFDA device enforcement)
Reported May 16, 2018
Connecting Tube - Female to Male Luer Lock, HPCT8.8-60-M-FM Product Usage: The connecting tube is intended to be a…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Cook Inc.
Matched: Brand — Cap-adapter assembly of the device may potentially not be adequately tightened, possibly leading to fluid leakage from or air aspiration into the…
5 more products in this recall
FDA (openFDA device enforcement)
Reported May 9, 2018
StoneBreaker Pneumatic Lithotripter, Catalog number: SBL-KIT1; GPN: G52604 UDI:(01)00827002526044
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Cook Inc.
Matched: Brand — The interior of the product may not be sterilized to the appropriate Sterility Assurance Level when following the reprocessing instructions in the…
6 more products in this recall
FDA (openFDA device enforcement)
Reported May 2, 2018
Advance¿ 35LP Low-Profile PTA Balloon Dilatation Catheter; Catalog numbers: PTA5-35-135-6-2 .0 and PTA5-35-135-4-4 .0;…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Cook Inc.
Matched: Brand — Incorrect product labeling. Product labeled as 6mm x 2cm balloon are packaged with a 4mm x 4 cm balloon label and vice-versa.
FDA (openFDA device enforcement)
Reported Apr 25, 2018
MINC Benchtop Incubator (Mini Incubator) catalog (K-MINC-1000 US) G46022 is a microprocessor controlled, gassed,…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Cook Inc.
Matched: Brand — The temperature of the incubation lids of the MINC Bench top Incubators may become too high or too low for proper gamete/embryo incubation due to…
3 more products in this recall
FDA (openFDA device enforcement)
Reported Apr 4, 2018
Norm-Ject Tuberkulin Syringe, Catalog Number: K-ATS-1000, Global Product Number: G19871 Product Usage: Used to place in…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Cook Inc.
Matched: Brand — Certain lots of in vitro fertilization (IVF) products were distributed without completed finished device quality testing with potential adverse…
3 more products in this recall
FDA (openFDA device enforcement)
Reported Mar 21, 2018
Amplatz Extra Stiff Whisker Wire Guide
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Cook Inc.
Matched: Brand — Label does not state that the product is heparin-coated.
19 more products in this recall
FDA (openFDA device enforcement)
Reported Mar 7, 2018
Mallinckrodt Institute Percutaneous Gastrostomy Set Product Usage: Intended for the percutaneous placement of a…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Cook Inc.
Matched: Brand · Reason for recall — Cook has identified that the affected lots may contain wire guides that were loaded backwards into the wire guide holder.
2 more products in this recall
FDA (openFDA device enforcement)
Reported Feb 21, 2018
Central Venous Catheter Set Triple Lumen Polyurethane, Catalog Identifier: C-UTLM-501J Product Usage: The central…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Cook Inc.
Matched: Brand — Central venous catheters may not fit over guide wire potentially causing procedure delay.
4 more products in this recall
FDA (openFDA device enforcement)
Reported Jun 21, 2017
Pereyra-Raz Ligature Carrier
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Cook Inc.
Matched: Brand — reprocessing instructions do not provide sufficient detailed information for the cleaning, disinfection, and sterilization of these products
7 more products in this recall
FDA (openFDA device enforcement)
Reported Jun 14, 2017
Willscher Vas Reapproximator Set, Surgical Instrument, Supplied sterilized by ethylene oxide gas in peel-open packages.…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Cook Inc.
Matched: Brand · Reason for recall — COOK Medical is initiating a voluntary recall of multiple products because the reprocessing instructions do not provide sufficient detailed…
5 more products in this recall
FDA (openFDA device enforcement)
Reported Apr 26, 2017
Bush DL Ureteral Illuminating Catheter Set Bush SL Ureteral Illuminating Catheter Set
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Cook Inc.
Matched: Brand — Product may overheat, melt, and burn patient.
FDA (openFDA device enforcement)
Reported Mar 8, 2017
Check-Flo Performer Introducer, Individual product is packaged in a Tyvek-film sterilizable outer pouch. Introducers…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Cook Inc.
Matched: Brand — Devices using a specific hemostatic valve design, referred to as a blue valve or polyisoprene valve, have an increase in reports of blood loss…
6 more products in this recall
FDA (openFDA device enforcement)
Reported Dec 21, 2016
Cook Spectrum Minocycline/Rifampin Impregnated Double Lumen Central Venous Catheter Tray Cook Spectrum…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Cook Inc.
Matched: Brand · Product · Product details · Reason for recall — Cook Medical has received reports of the trays containing the incorrect needle, which in some cases could result in the inability to pass a wire…
FDA (openFDA device enforcement)
Reported Aug 31, 2016
Roadrunner Uniglide Hydrophilic Wire Guide, Catalog Numbers and GPN: HPWA-18-260, G30489; HPWA-18-320, G30490;…
High riskUsing this product could cause serious injury, illness or death — stop using it now.Cook Inc.
Matched: Brand — Potential coating contamination with glass particles.
14 more products in this recall
FDA (openFDA device enforcement)
Reported Mar 30, 2016
UltraxxTM Nephrostomy Balloon Set The Ultraxx" Nephrostomy Balloon Set consists of a radiopaque balloon catheter,…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Cook Inc.
Matched: Brand · Reason for recall — Cook Medical is voluntarily recalling specific lots of the Ultraxx" Nephrostomy Balloon Set and the Ascend¿ AQ¿ Ureteral Dilation Balloon Catheter…
1 more product in this recall
FDA (openFDA device enforcement)
Reported Mar 9, 2016
Kopans Breast Lesion Localization Needle The Kopans Breast Lesion Localization Needle consists of a bevel-tip needle…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Cook Inc.
Matched: Brand — Product potentially exposed to body fluids during processing. Potential adverse events that may occur as a result of the foreign matter include blood…
FDA (openFDA device enforcement)
Reported Mar 2, 2016
Shuttle Select Slip-Cath Catheter. Angiographic catheter. For use in angiographic procedures as a conduit for the…
High riskUsing this product could cause serious injury, illness or death — stop using it now.Cook Inc.
Matched: Brand — Reports of catheter tip splits and or separation. Loss of device function, medical intervention to retrieve separated segment, or complications…
5 more products in this recall
FDA (openFDA device enforcement)
Reported Dec 23, 2015
VentriClear¿ II Ventricular Drainage Catheter Set. Allows external access and drainage of cerebrospinal fluid (CSF)…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Cook Inc.
Matched: Brand · Reason for recall — Cook Medical initiated a voluntary recall of specific lot numbers of the VentriClear II Ventricular Drainage Catheter Set due to the device being…
FDA (openFDA device enforcement)
Reported Nov 18, 2015
Cook Medical CXI Support Catheter 2.6FR curved catheter and 4.0FR straight catheter, for cardiovascular use.
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Cook Inc.
Matched: Brand · Product · Product details · Reason for recall — Cook Medical has received six product complaints associated with reports of the 2.6FR curved catheter being mixed with the 4.0FR straight catheter…
FDA (openFDA device enforcement)
Reported Aug 12, 2015
Beacon Tip Torcon NB Advantage Catheter. Angiographic catheter. For use in angiographic procedures as a conduit for the…
High riskUsing this product could cause serious injury, illness or death — stop using it now.Cook Inc.
Matched: Brand — Reports of catheter tip splits and or separation. Loss of device function, medical intervention to retrieve separated segment, or complications…
2 more products in this recall
FDA (openFDA device enforcement)
Reported Jul 29, 2015
Ring Transjugular Intrahepatic Access Set Product Usage: The Ring Transjugular Intrahepatic Access Sets are intended…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Cook Inc.
Matched: Brand · Reason for recall — Cook Inc. is initiating a voluntary recall of the Ring Transjugular Intrahepatic Access Set and the Flexor RTPS Introduce Sheath due to complaints of…
1 more product in this recall
FDA (openFDA device enforcement)
Reported Jul 1, 2015
LapSac Surgical Tissue Pouch. The current intended use for the LapSac Surgical Tissue Pouch is for isolating tissue…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Cook Inc.
Matched: Brand — Includes Information not stated in the intended use.
FDA (openFDA device enforcement)
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