The Recall Desk

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.

226–250 of 264

  • HighFDA (Devices)·Z-1387-2017·2017-03-08

    Cook Inc. Recalls Check-Flo Performer Introducers Due to Blood Loss Reports

    Cook Inc. is recalling 884 Check-Flo Performer Introducers because a specific valve design is associated with increased reports of blood loss.

    Product
    Check-Flo Performer Introducer, Individual product is packaged in a Tyvek-film sterilizable outer pouch. Introducers are intended for introduction of balloons, closed and non-tapered end catheters or other diagnostic and interventional devices.
    Category
    Medical Device
    Distribution
    46 states
  • HighFDA (Devices)·Z-1390-2017·2017-03-08

    Cook Inc. Recalls Flexor Radial Access Sets Due to Blood Loss Reports

    Cook Inc. is recalling 41,975 Flexor Radial Access Sets because a specific hemostatic valve design is associated with increased reports of blood loss.

    Product
    Flexor Radial Access Set, Individual product is packaged in a Tyvek-film sterilizable outer pouch. The Flexor¿ Radial Hydrophilic Introducer Access Set is intended to introduce diagnostic and interventional devices In radial artery access procedures
    Category
    Medical Device
    Distribution
    46 states
  • HighFDA (Devices)·Z-1389-2017·2017-03-08

    Cook Inc. Recalls Check-Flo Hemostasis Assemblies Due to Blood Loss Reports

    Cook Inc. is recalling 1,589 Check-Flo Hemostasis Assemblies because reports indicate increased blood loss associated with the device's valve design.

    Product
    Check-Flo Hemostasis Assembly, Individual product is packaged in a Tyvek-film sterilizable outer pouch.
    Category
    Medical Device
    Distribution
    46 states
  • HighFDA (Devices)·Z-0733-2017·2016-12-21

    Cook Medical Recalls Central Venous Catheter Trays Due to Incorrect Needles

    Cook Medical is recalling 99 units of Spectrum Minocycline/Rifampin Impregnated Central Venous Catheter Trays because they may contain incorrect needles, potentially preventing wire guide passage.

    Product
    Cook Spectrum Minocycline/Rifampin Impregnated Double Lumen Central Venous Catheter Tray Cook Spectrum Minocycline/Rifampin Impregnated Triple Lumen Central Venous Catheter Tray
    Category
    Medical Device
    Distribution
    16 states
  • SevereFDA (Devices)·Z-2613-2016·2016-08-31

    Cook Inc. Recalls Shuttle Select Slip-Cath Catheters Due to Tip Fracture

    Cook Inc. is recalling 60,302 Shuttle Select Slip-Cath catheters worldwide due to polymer degradation causing tip fracture and separation.

    Product
    Shuttle Select Slip-Cath Catheter, Intravascular, Diagnostic The catheters are intended for use in angiographic procedures by physicians trained and experienced in angiographic techniques
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-2618-2016·2016-08-31

    Cook Inc. Recalls Liver Access and Biopsy Needle Sets Due to Tip Fracture

    Cook Inc. is recalling 52,756 Liver Access and Biopsy Needle Sets because polymer degradation can cause the catheter tip to fracture or separate, potentially leading to device fragments in the body.

    Product
    Liver Access and Biopsy Needle Set Biopsy needle kit Intended for use in obtaining liver histology samples via a jugular vein approach.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-2620-2016·2016-08-31

    Cook Inc. Recalls Aprima Access Nonvascular Introducer Sets Due to Tip Fracture

    Cook Inc. is recalling Aprima Access Nonvascular Introducer Sets because polymer degradation can cause the catheter tip to fracture or separate, potentially leading to medical complications.

    Product
    Aprima Access Nonvascular Introducer Set Accessories, Catheter Intended for single-puncture percutaneous access to facilitate placement of an .038 inch (0.97 mm) diameter working wire guide for interventional radiology procedures
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-2611-2016·2016-08-31

    Cook Inc. Recalls Beacon Tip Royal Flush Plus High-Flow Catheters

    Cook Inc. is recalling 532,395 Beacon Tip Royal Flush Plus High-Flow Catheters worldwide due to polymer degradation that can cause the catheter tip to fracture or separate.

    Product
    Beacon Tip Royal Flush Plus High-Flow Catheter Catheter, Intravascular, Diagnostic The catheters are intended for use in angiographic procedures by physicians trained and experienced in angiographic techniques. Standard techniques for placement of vascular access sheaths, angio
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-2616-2016·2016-08-31

    Cook Inc. Recalls Haskal Transjugular Intrahepatic Portal Access Sets

    Cook Inc. is recalling Haskal Transjugular Intrahepatic Portal Access Sets due to polymer degradation that can cause catheter tip fracture and separation.

    Product
    Haskal Transjugular Intrahepatic Portal Access Set Introducer, catheter Intended for transjugular liver access in diagnostic and interventional procedures.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-2617-2016·2016-08-31

    Cook Inc. Recalls Kumpe Access Catheters Due to Tip Fracture Risk

    Cook Inc. is recalling 26,076 Kumpe Access Catheters because polymer degradation can cause the tip to fracture or separate, potentially leading to device fragments in the body.

    Product
    Kumpe Access Catheter Cathether, Ureteral, General & Plastic Surgery Used in combination with a HiWire, Bentson, or other flexible-tipped wire guide to gain difficult ureteral access beyond a redundant or tortuous ureteral segment
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-2619-2016·2016-08-31

    Cook Inc. Recalls Neff DAgostino Percutaneous Access Sets Due to Tip Fracture

    Cook Inc. is recalling 5,020 Neff DAgostino Percutaneous Access Sets because polymer degradation can cause the catheter tip to fracture or separate, potentially leading to device fragments in the body.

    Product
    Neff DAgostino Percutaneous Access Set Accessories, Catheter Intended for single-puncture percutaneous access to facilitate placement of an .038 inch (0.97 mm) diameter working wire guide for interventional radiology procedures
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-2621-2016·2016-08-31

    Cook Inc. Recalls Selective Salpingography Catheters Due to Tip Fracture Risk

    Cook Inc. is recalling 7,819 Selective Salpingography Catheters with Beacon Tip due to polymer degradation that can cause the catheter tip to fracture or separate.

    Product
    Selective Salpingography Catheter with Beacon Tip Cannula, Manipulator/ Injector, Uterine Used for injection of contrast medium into the fallopian tube(s) for selective salpingography.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-2623-2016·2016-08-31

    Cook Inc. Recalls White Lumax Guiding Coaxial Catheters Due to Tip Fracture

    Cook Inc. is recalling 3,425 White Lumax Guiding Coaxial Catheters worldwide due to polymer degradation that can cause the catheter tip to fracture or separate.

    Product
    White Lumax Guiding Coaxial Catheter Catheter, Percutaneous Intended for the delivery of angioplasty balloons and other types of interventional devices.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-2615-2016·2016-08-31

    Cook Inc. Recalls FluoroSet Radiographic Tubal Assessment Sets

    Cook Inc. is recalling 1,881 FluoroSet Radiographic Tubal Assessment Sets due to polymer degradation that can cause catheter tip fracture or separation.

    Product
    FluoroSet Radiographic Tubal Assessment Set Cannula, Manipulator/ Injector, Uterine Used for instillation of contrast media into the uterine cavity for radiographic evaluation of the uterine cavity and for injection of appropriate contrast media into the fallopian tubes for eva
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-2610-2016·2016-08-31

    Cook Inc. Recalls Beacon Tip Torcon NB Advantage Catheters Due to Tip Fracture

    Cook Inc. is recalling Beacon Tip Torcon NB Advantage Catheters because polymer degradation can cause the tip to fracture or separate, potentially leading to device fragments in the body.

    Product
    Beacon Tip Torcon NB Advantage Catheter Catheter, Intravascular, Diagnostic
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-2614-2016·2016-08-31

    Cook Inc. Recalls Slip-Cath Beacon Tip Catheters Due to Tip Fracture

    Cook Inc. is recalling Slip-Cath Beacon Tip Catheters because polymer degradation can cause the tip to fracture or separate, potentially leading to device fragments in the body.

    Product
    Slip-Cath Beacon Tip Catheter Catheter, Intravascular, Diagnostic The catheters are intended for use in angiographic procedures by physicians trained and experienced in angiographic techniques.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-2622-2016·2016-08-31

    Cook Inc. Recalls Transluminal Biliary Biopsy Forceps Sets Due to Tip Fracture

    Cook Inc. is recalling 2,606 Transluminal Biliary Biopsy Forceps Sets because polymer degradation can cause the catheter tip to fracture or separate, potentially leading to device fragments in the body.

    Product
    Transluminal Biliary Biopsy Forceps Set Forceps, Biopsy, Non-Electric Intended for access to and biopsy of tissue within the biliary ductal system
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-2612-2016·2016-08-31

    Cook Inc. Recalls Beacon Tip Catheters Due to Tip Fracture Risk

    Cook Inc. is recalling Beacon Tip catheters because polymer degradation can cause the tip to fracture or separate, potentially leading to device fragments in the body.

    Product
    Beacon Tip Centimeter Sizing Catheter Beacon Tip White Vessel Sizing Catheter Beacon Tip Vessel Sizing Catheter Catheter, Intravascular, Diagnostic The catheters are intended for use in angiographic procedures by physicians trained and experienced in angiographic techniques
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2537-2016·2016-08-31

    Cook Inc. Recalls Roadrunner Uniglide Hydrophilic Wire Guides Due to Glass Contamination

    Cook Inc. is recalling Roadrunner Uniglide Hydrophilic Wire Guides because they may be contaminated with glass particles. The recall covers 8,750 devices distributed worldwide.

    Product
    Roadrunner Uniglide Hydrophilic Wire Guide, Catalog Numbers and GPN: HPWA-18-260, G30489; HPWA-18-320, G30490; HPWA-25-260, G30491; HPWA-35-260, G30492; HPWAS-35-260, G30506; HPW-35-150, G56149; HPW-35-180, G56150; HPWS-35-150, G56152; HPWS-35-180, G56153; HPWA-35-80, G56172; HPW
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1238-2016·2016-03-30

    Cook Medical Recalls Ureteral Balloon Catheters Due to Labeling Mix-Up

    Cook Medical is voluntarily recalling specific lots of Ascend AQ Ureteral Dilation Balloon Catheter Sets and Ultraxx Nephrostomy Balloon Sets due to a labeling error where packages may contain the wrong product.

    Product
    Ascend¿ AQ¿ Ureteral Dilation Balloon Catheter Set The Ascend¿ AQ¿ Ureteral Dilation Balloon Catheter Set consists of a radiopaque balloon catheter and inflation device. The Ascend¿ AQ¿ Ureteral Dilation Balloon Catheter Set is used for transluminal dilation of ureteral strictur
    Category
    Medical Device
    Distribution
    6 states
  • ModerateFDA (Devices)·Z-1237-2016·2016-03-30

    Cook Medical Recalls Nephrostomy Balloon Sets Due to Labeling Mix-up

    Cook Medical is voluntarily recalling specific lots of Ultraxx Nephrostomy Balloon Sets and Ascend AQ Ureteral Dilation Balloon Catheter Sets because of a labeling mix-up.

    Product
    UltraxxTM Nephrostomy Balloon Set The Ultraxx" Nephrostomy Balloon Set consists of a radiopaque balloon catheter, radiopaque sheath, and inflation device. The Ultraxx" Nephrostomy Balloon Set is used to dilate the musculofascia, renal capsule, and parenchyma to establish and mai
    Category
    Medical Device
    Distribution
    6 states
  • HighFDA (Devices)·Z-1028-2016·2016-03-09

    Cook Inc. Recalls Kopans Breast Lesion Localization Needles

    Cook Inc. is recalling 134 Kopans Breast Lesion Localization Needles because they may have been exposed to body fluids during processing, posing a potential risk of blood-borne pathogen transmission.

    Product
    Kopans Breast Lesion Localization Needle The Kopans Breast Lesion Localization Needle consists of a bevel-tip needle with centimeter markings and a hookwire. The hookwire features a burnish mark that allows the operator to ensure that the hookwire is within the needle tip during
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-0798-2016·2016-03-02

    Cook Inc. Recalls Shuttle Select Slip-Cath Catheters Due to Tip Splits

    Cook Inc. is recalling 9,519 Shuttle Select Slip-Cath Catheters worldwide due to reports of catheter tip splits and separation, which can cause loss of function or complications.

    Product
    Shuttle Select Slip-Cath 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 syst
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-0800-2016·2016-03-02

    Cook Inc. Recalls Single Lumen Pressure Monitoring Sets Due to Tip Fracture

    Cook Inc. is recalling 2,280 single-lumen pressure monitoring sets and trays because a manufacturing defect may cause catheter tips to fracture or separate.

    Product
    Single Lumen Pressure Monitoring 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
  • SevereFDA (Devices)·Z-0801-2016·2016-03-02

    Cook Inc. Recalls Femoral Artery Pressure Monitoring Catheters Due to Tip Fracture Risk

    Cook Inc. is recalling specific femoral artery pressure monitoring catheter sets and trays because a manufacturing defect may cause the catheter tip to fracture or separate.

    Product
    Femoral 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