Cook Recalls
266 recalls on record · December 1, 1969 to December 29, 2021 · Medical Devices, Vehicles
Recalls by year
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Count of recall notices naming this brand, by the year the recall was announced. A quiet year is not proof of a safe year.
Also filed under
The recall feeds record what looks like the same company under more than one name:
June 21, 2017Medical DevicesFDA
Cook Inc. recalls Clarke-Reich Laparoscopic Knot Pusher
Hazard: reprocessing instructions do not provide sufficient detailed information for the cleaning, disinfection, and sterilization of these products
June 21, 2017Medical DevicesFDA
Cook Inc. recalls Stamey Needle
Hazard: reprocessing instructions do not provide sufficient detailed information for the cleaning, disinfection, and sterilization of these products
June 21, 2017Medical DevicesFDA
Cook Inc. recalls Pereyra Ligature Carrier 75
Hazard: reprocessing instructions do not provide sufficient detailed information for the cleaning, disinfection, and sterilization of these products
June 21, 2017Medical DevicesFDA
Cook Inc. recalls Pereyra-Raz Ligature Carrier
Hazard: reprocessing instructions do not provide sufficient detailed information for the cleaning, disinfection, and sterilization of these products
June 14, 2017Medical DevicesFDA
Cook Inc. recalls LapSac Introducer Set, Bag, Extraction, Supplied sterilized by ethylene oxide gas in peel-open packages. Used to aid
Hazard: COOK Medical is initiating a voluntary recall of multiple products because the reprocessing instructions do not provide sufficient detailed information for the cleaning, disinfection, and sterilization of these products.
June 14, 2017Medical DevicesFDA
Cook Inc. recalls LapSac Introducer, Supplied sterilized by ethylene oxide gas in peel-open packages. Used to aid in the introduction o
Hazard: COOK Medical is initiating a voluntary recall of multiple products because the reprocessing instructions do not provide sufficient detailed information for the cleaning, disinfection, and sterilization of these products.
June 14, 2017Medical DevicesFDA
Cook Inc. recalls Endoscopic Curved Needle, Surgical Needle Guide, Supplied sterilized by ethylene oxide gas in peel-open packages. Use
Hazard: COOK Medical is initiating a voluntary recall of multiple products because the reprocessing instructions do not provide sufficient detailed information for the cleaning, disinfection, and sterilization of these products.
June 14, 2017Medical DevicesFDA
Cook Inc. recalls Willscher Vas Reapproximator Plate, Surgical Instrument, Supplied sterilized by ethylene oxide gas in peel-open packages
Hazard: COOK Medical is initiating a voluntary recall of multiple products because the reprocessing instructions do not provide sufficient detailed information for the cleaning, disinfection, and sterilization of these products.
June 14, 2017Medical DevicesFDA
Cook Inc. recalls Willscher Vas Skewers, Surgical Instrument, Supplied sterilized by ethylene oxide gas in peel-open packages. Used to
Hazard: COOK Medical is initiating a voluntary recall of multiple products because the reprocessing instructions do not provide sufficient detailed information for the cleaning, disinfection, and sterilization of these products.
June 14, 2017Medical DevicesFDA
Cook Inc. recalls Willscher Vas Reapproximator Set, Surgical Instrument, Supplied sterilized by ethylene oxide gas in peel-open packages.
Hazard: COOK Medical is initiating a voluntary recall of multiple products because the reprocessing instructions do not provide sufficient detailed information for the cleaning, disinfection, and sterilization of these products.
April 26, 2017Medical DevicesFDA
Cook Inc. recalls Bush DL Ureteral Illuminating Catheter Set Bush SL Ureteral Illuminating Catheter Set
Hazard: Product may overheat, melt, and burn patient.
March 8, 2017Medical DevicesFDA
Cook Inc. recalls TriForce Peripheral Crossing Set, Individual product is packaged in a Tyvek-film sterilizable outer pouch. The TriForce
Hazard: Devices using a specific hemostatic valve design, referred to as a blue valve or polyisoprene valve, have an increase in reports of blood loss associated with the devices which could result in delay in procedure and blood loss from patients.
March 8, 2017Medical DevicesFDA
Cook Inc. recalls Check-Flo Introducer Hausdorf-Lock Atrial, Individual product is packaged in a Tyvek-film sterilizable outer pouch. Int
Hazard: Devices using a specific hemostatic valve design, referred to as a blue valve or polyisoprene valve, have an increase in reports of blood loss associated with the devices which could result in delay in procedure and blood loss from patients.
March 8, 2017Medical DevicesFDA
Cook Inc. recalls Micropuncture Check-Flo Performer Introducer Set, Individual product is packaged in a Tyvek-film sterilizable outer pouc
Hazard: Devices using a specific hemostatic valve design, referred to as a blue valve or polyisoprene valve, have an increase in reports of blood loss associated with the devices which could result in delay in procedure and blood loss from patients.
March 8, 2017Medical DevicesFDA
Cook Inc. recalls Flexor Radial Access Set, Individual product is packaged in a Tyvek-film sterilizable outer pouch. The Flexor¿ Radial H
Hazard: Devices using a specific hemostatic valve design, referred to as a blue valve or polyisoprene valve, have an increase in reports of blood loss associated with the devices which could result in delay in procedure and blood loss from patients.
March 8, 2017Medical DevicesFDA
Cook Inc. recalls Check-Flo Hemostasis Assembly, Individual product is packaged in a Tyvek-film sterilizable outer pouch.
Hazard: Devices using a specific hemostatic valve design, referred to as a blue valve or polyisoprene valve, have an increase in reports of blood loss associated with the devices which could result in delay in procedure and blood loss from patients.
March 8, 2017Medical DevicesFDA
Cook Inc. recalls Check-Flo Performer Introducer Set, Individual product is packaged in a Tyvek-film sterilizable outer pouch. Introducer
Hazard: Devices using a specific hemostatic valve design, referred to as a blue valve or polyisoprene valve, have an increase in reports of blood loss associated with the devices which could result in delay in procedure and blood loss from patients.
March 8, 2017Medical DevicesFDA
Cook Inc. recalls Check-Flo Performer Introducer, Individual product is packaged in a Tyvek-film sterilizable outer pouch. Introducers ar
Hazard: Devices using a specific hemostatic valve design, referred to as a blue valve or polyisoprene valve, have an increase in reports of blood loss associated with the devices which could result in delay in procedure and blood loss from patients.
December 21, 2016Medical DevicesFDA
Cook Inc. recalls Cook Spectrum Minocycline/Rifampin Impregnated Double Lumen Central Venous Catheter Tray Cook Spectrum Minocycline/Rifa
Hazard: 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 guide through the needle. Potential adverse events that may occur as a result of utilizing needles of incorrect size include delay in treatment, which could be critical in an emergent situation. There have been no reports of illness or injury associated with this issue.
August 31, 2016Medical DevicesFDA
Cook Inc. recalls White Lumax Guiding Coaxial Catheter Catheter, Percutaneous Intended for the delivery of angioplasty balloons and othe
Hazard: Increase in reports of polymer degradation of the catheter tip, resulting in tip fracture and/or separation. degradation could include loss of device function, separation of a device segment leading to medical intervention, or complications resulting from a separated segment. Such complications include device fragments in the vascular system, genitourinary system, or other soft tissues. Fragments within the vascular system could result in embolization to the heart or lungs, or occluding blood flow to end organs.
August 31, 2016Medical DevicesFDA
Cook Inc. recalls Transluminal Biliary Biopsy Forceps Set Forceps, Biopsy, Non-Electric Intended for access to and biopsy of tissue with
Hazard: Increase in reports of polymer degradation of the catheter tip, resulting in tip fracture and/or separation. degradation could include loss of device function, separation of a device segment leading to medical intervention, or complications resulting from a separated segment. Such complications include device fragments in the vascular system, genitourinary system, or other soft tissues. Fragments within the vascular system could result in embolization to the heart or lungs, or occluding blood flow to end organs.
August 31, 2016Medical DevicesFDA
Cook Inc. recalls Selective Salpingography Catheter with Beacon Tip Cannula, Manipulator/ Injector, Uterine Used for injection of contra
Hazard: Increase in reports of polymer degradation of the catheter tip, resulting in tip fracture and/or separation. degradation could include loss of device function, separation of a device segment leading to medical intervention, or complications resulting from a separated segment. Such complications include device fragments in the vascular system, genitourinary system, or other soft tissues. Fragments within the vascular system could result in embolization to the heart or lungs, or occluding blood flow to end organs.
August 31, 2016Medical DevicesFDA
Cook Inc. recalls Aprima Access Nonvascular Introducer Set Accessories, Catheter Intended for single-puncture percutaneous access to fac
Hazard: Increase in reports of polymer degradation of the catheter tip, resulting in tip fracture and/or separation. degradation could include loss of device function, separation of a device segment leading to medical intervention, or complications resulting from a separated segment. Such complications include device fragments in the vascular system, genitourinary system, or other soft tissues. Fragments within the vascular system could result in embolization to the heart or lungs, or occluding blood flow to end organs.
August 31, 2016Medical DevicesFDA
Cook Inc. recalls Neff DAgostino Percutaneous Access Set Accessories, Catheter Intended for single-puncture percutaneous access to facil
Hazard: Increase in reports of polymer degradation of the catheter tip, resulting in tip fracture and/or separation. degradation could include loss of device function, separation of a device segment leading to medical intervention, or complications resulting from a separated segment. Such complications include device fragments in the vascular system, genitourinary system, or other soft tissues. Fragments within the vascular system could result in embolization to the heart or lungs, or occluding blood flow to end organs.
August 31, 2016Medical DevicesFDA
Cook Inc. recalls Liver Access and Biopsy Needle Set Biopsy needle kit Intended for use in obtaining liver histology samples via a jugul
Hazard: Increase in reports of polymer degradation of the catheter tip, resulting in tip fracture and/or separation. degradation could include loss of device function, separation of a device segment leading to medical intervention, or complications resulting from a separated segment. Such complications include device fragments in the vascular system, genitourinary system, or other soft tissues. Fragments within the vascular system could result in embolization to the heart or lungs, or occluding blood flow to end organs.
August 31, 2016Medical DevicesFDA
Cook Inc. recalls Kumpe Access Catheter Cathether, Ureteral, General & Plastic Surgery Used in combination with a HiWire, Bentson, or ot
Hazard: Increase in reports of polymer degradation of the catheter tip, resulting in tip fracture and/or separation. degradation could include loss of device function, separation of a device segment leading to medical intervention, or complications resulting from a separated segment. Such complications include device fragments in the vascular system, genitourinary system, or other soft tissues. Fragments within the vascular system could result in embolization to the heart or lungs, or occluding blood flow to end organs.
August 31, 2016Medical DevicesFDA
Cook Inc. recalls Haskal Transjugular Intrahepatic Portal Access Set Introducer, catheter Intended for transjugular liver access in diag
Hazard: Increase in reports of polymer degradation of the catheter tip, resulting in tip fracture and/or separation. degradation could include loss of device function, separation of a device segment leading to medical intervention, or complications resulting from a separated segment. Such complications include device fragments in the vascular system, genitourinary system, or other soft tissues. Fragments within the vascular system could result in embolization to the heart or lungs, or occluding blood flow to end organs.
August 31, 2016Medical DevicesFDA
Cook Inc. recalls FluoroSet Radiographic Tubal Assessment Set Cannula, Manipulator/ Injector, Uterine Used for instillation of contrast
Hazard: Increase in reports of polymer degradation of the catheter tip, resulting in tip fracture and/or separation. degradation could include loss of device function, separation of a device segment leading to medical intervention, or complications resulting from a separated segment. Such complications include device fragments in the vascular system, genitourinary system, or other soft tissues. Fragments within the vascular system could result in embolization to the heart or lungs, or occluding blood flow to end organs.
August 31, 2016Medical DevicesFDA
Cook Inc. recalls Slip-Cath Beacon Tip Catheter Catheter, Intravascular, Diagnostic The catheters are intended for use in angiographic p
Hazard: Increase in reports of polymer degradation of the catheter tip, resulting in tip fracture and/or separation. degradation could include loss of device function, separation of a device segment leading to medical intervention, or complications resulting from a separated segment. Such complications include device fragments in the vascular system, genitourinary system, or other soft tissues. Fragments within the vascular system could result in embolization to the heart or lungs, or occluding blood flow to end organs.
August 31, 2016Medical DevicesFDA
Cook Inc. recalls Shuttle Select Slip-Cath Catheter, Intravascular, Diagnostic The catheters are intended for use in angiographic proced
Hazard: Increase in reports of polymer degradation of the catheter tip, resulting in tip fracture and/or separation. degradation could include loss of device function, separation of a device segment leading to medical intervention, or complications resulting from a separated segment. Such complications include device fragments in the vascular system, genitourinary system, or other soft tissues. Fragments within the vascular system could result in embolization to the heart or lungs, or occluding blood flow to end organs.