Manufacturer

Cook, Inc.

264 recalls in our database name Cook, Inc. as the manufacturing or recalling firm.

What the numbers show

Total: 264
Critical: 5
Severe: 51
Most recent: 2021-12-29

Of the 264 recalls from Cook, Inc. we have scored against our rubric, 5 (2%) are Critical — deaths or serious injuries reported, or the agency’s own highest classification — and 51 (19%) are Severe.

About this listing

The manufacturer string comes from the agency’s own source notice — for FDA recalls, the “recalling firm” field; for NHTSA recalls, the vehicle manufacturer; for CPSC recalls, the firm-of-record on the joint press release. A single corporate family can appear under multiple manufacturer strings as agency notices aren’t standardized on a canonical name. If you don’t see recalls you expect, try a parent-company search or a broader full-text search.

Severity scores below are computed from the agency’s classification and the recall text, never from manufacturer behaviour or history. Many manufacturers issue routine corrective actions (software updates, labelling corrections) that are correctly scored low — having recalls on this list isn’t inherently a quality signal.

251–264 of 264

SevereFDA (Devices)·Z-0799-2016·2016-03-02
Cook Inc. Recalls Single Lumen Central Venous Catheter Sets
Cook Inc. is recalling 1,341 single-lumen central venous catheter sets and trays due to a manufacturing defect that may cause catheter tip fracture or separation.
Product
Single Lumen Central Venous Catheter Sets and Trays The subject sets and trays are comprised of a single-lumen uncoated or heparin-coated catheter. Product catalog numbers with heparin coating are designated by the suffix BH.
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0802-2016·2016-03-02
Cook Inc. Recalls Radial Artery Pressure Monitoring Catheter Sets
Cook Inc. is recalling radial artery pressure monitoring catheter sets because a manufacturing defect may cause the catheter tip to fracture or separate.
Product
Radial Artery Pressure Monitoring Catheter Sets and Trays The subject sets and trays are comprised of a single-lumen uncoated or heparin-coated catheter. Product catalog numbers with heparin coating are designated by the suffix BH.
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-0865-2016·2016-03-02
Cook Inc. Recalls Flexor Check-Flo Introducers Due to Incorrect Packaging
Cook Inc. is recalling 25 Flexor Check-Flo Introducers because some packages labeled as 6.0Fr actually contained 5.0Fr devices.
Product
Flexor Check-Flo Introducer, Catheter introducer, Catalog #: KCFW-6.0-35-70-RB-HFANL0-HC Intended for introduction of balloons, closed and non-tapered end catheters or diagnostic and interventional devices
Category
Medical Device
Distribution
8 states
HighFDA (Devices)·Z-0416-2016·2015-12-23
Cook Medical Recalls VentriClear II Catheters Due to Sterilization Error
Cook Medical is recalling specific lots of VentriClear II Ventricular Drainage Catheter Sets because double sterilization may reduce the antibiotic coating below labeled levels.
Product
VentriClear¿ II Ventricular Drainage Catheter Set. Allows external access and drainage of cerebrospinal fluid (CSF) from the ventricles of the brain.
Category
Medical Device
Distribution
4 states
ModerateFDA (Devices)·Z-0244-2016·2015-11-18
Cook Medical CXI Support Catheters Recalled Due to Product Mixing
Cook Inc. is recalling specific lots of CXI Support Catheters because the 2.6FR curved and 4.0FR straight catheters were mixed during processing.
Product
Cook Medical CXI Support Catheter 2.6FR curved catheter and 4.0FR straight catheter, for cardiovascular use.
Category
Medical Device
Distribution
10 states
SevereFDA (Devices)·Z-2319-2015·2015-08-12
Cook Inc. Recalls Slip-Cath Beacon Tip Catheters Due to Tip Separation
Cook Inc. is recalling Slip-Cath Beacon Tip Catheters because the tips may split or separate, potentially causing loss of function or complications.
Product
Slip-Cath Beacon Tip Catheter. Angiographic catheter. For use in angiographic procedures as a conduit for the delivery of contrast media and can help physicians diagnose occlusion or stenosis. The catheters are designed for percutaneous introduction into the vascular system
Category
Medical Device
Distribution
Distributed nationwide
SevereFDA (Devices)·Z-2318-2015·2015-08-12
Cook Inc. Recalls Beacon Tip Royal Flush Plus High-Flow Catheters
Cook Inc. is recalling Beacon Tip Royal Flush Plus High-Flow Catheters due to reports of tip splits or separation that may cause loss of function or complications.
Product
Beacon Tip Royal Flush Plus High-Flow Catheter. Angiographic catheter. For use in angiographic procedures as a conduit for the delivery of contrast media and can help physicians diagnose occlusion or stenosis. The catheters are designed for percutaneous introduction into th
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-2317-2015·2015-08-12
Cook Inc. Recalls Beacon Tip Torcon NB Advantage Catheters
Cook Inc. is recalling Beacon Tip Torcon NB Advantage Catheters due to reports of tip splits or separation, which may cause loss of function or complications.
Product
Beacon Tip Torcon NB Advantage Catheter. Angiographic catheter. For use in angiographic procedures as a conduit for the delivery of contrast media and can help physicians diagnose occlusion or stenosis. The catheters are designed for percutaneous introduction into the vascula
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-2100-2015·2015-07-29
Cook Inc. Recalls Ring Transjugular Intrahepatic Access Set Due to Dilator Length
Cook Inc. is voluntarily recalling 661 Ring Transjugular Intrahepatic Access Sets and Flexor RTPS Introduce Sheaths because the dilators are too long.
Product
Ring Transjugular Intrahepatic Access Set Product Usage: The Ring Transjugular Intrahepatic Access Sets are intended for transjugular liver access in diagnostic and interventional procedures. The Ring Transjugular Intrahepatic Access Set consists of the following components:
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-2101-2015·2015-07-29
Cook Inc. Recalls Flexor RTPS Guiding Sheaths Due to Dilator Length Complaints
Cook Inc. is voluntarily recalling Flexor RTPS Guiding Sheaths and Ring Transjugular Intrahepatic Access Sets because users reported the included dilators were too long.
Product
Flexor RTPS Guiding Sheath Product Usage: The Flexor RTPS Guiding Sheaths are intended for introduction of balloons, closed and non-tapered end catheters or other diagnostic and interventional devices. These curved sheaths are manufactured from material incorporating a stainl
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-1830-2015·2015-07-01
Cook Inc. Recalls LapSac Surgical Tissue Pouches Due to Labeling Error
Cook Inc. is recalling 123,184 LapSac Surgical Tissue Pouches because the labeling includes information not stated in the intended use.
Product
LapSac Surgical Tissue Pouch. The current intended use for the LapSac Surgical Tissue Pouch is for isolating tissue during, or prior to, surgical removal and/or morcellation. The device is a reinforced pouch with an inner liner and drawstring closure. The device may be used t
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-2243-2014·2014-09-03
Cook CloverSnare 4-Loop Vascular Retrieval Snare Recalled for Tip Separation
Cook Inc. is recalling CloverSnare 4-Loop Vascular Retrieval Snares because the snare may separate from the distal tip of the wire.
Product
CloverSnare 4-Loop Vascular Retrieval Snare. Product is packaged in a Tyvek-film sterilizable outer package and is supplied one pouch in a box. The CloverSnare 4-Loop Vascular Retriever is intended for use in the cardiovascular system to manipulate and retrieve foreign object
Category
Medical Device
Distribution
37 states
CriticalFDA (Devices)·Z-1274-2013·2013-05-22
Cook Medical Recalls Zilver PTX Drug-Eluting Peripheral Stent Due to Catheter Fracture
Cook Medical is recalling Zilver PTX Drug-Eluting Peripheral Stents because the delivery system's inner catheter can fracture or separate after deployment, a defect linked to one reported death.
Product
Zilver¿ PTX¿ Drug-Eluting Peripheral Stent - 6 mm X 80mm; 125 cm, Rx, Sterile Product Usage: The Zilver PTX Drug -Eluting Peripheral Stent is a self expanding, small metal, mesh tube (stent) with the outer surface coated with the drug Paclitaxel that can be Implanted in an ar
Category
Medical Device
Distribution
Distributed nationwide
CriticalFDA (Devices)·Z-1275-2013·2013-05-22
Cook Medical Recalls Zilver PTX Drug-Eluting Peripheral Stent
Cook Medical is recalling Zilver PTX Drug-Eluting Peripheral Stents due to delivery system fractures and tip separations that resulted in one death.
Product
Zilver PTX Drug-Eluting Peripheral Stent, - 7 mm X 80mm; 125 cm, Rx, Sterile Product Usage: The Zilver PTX Drug -Eluting Peripheral Stent is a self expanding, small metal, mesh tube (stent) with the outer surface coated with the drug Paclitaxel that can be Implanted in an art
Category
Medical Device
Distribution
Distributed nationwide