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.

201–225 of 264

  • ModerateFDA (Devices)·Z-0831-2018·2018-03-07

    Cook Percutaneous Gastrojejunostomy Set Recalled for Backwards Wire Guides

    Cook Inc. is recalling Percutaneous Gastrojejunostomy Sets because wire guides may be loaded backwards into the holder.

    Product
    Percutaneous Gastrojejunostomy Set Product Usage: Intended for the percutaneous placement of a catheter for gastroenteric feeding
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0634-2018·2018-02-21

    Cook Inc. Recalls Spectrum Central Venous Catheter Trays Due to Fit Issues

    Cook Inc. is recalling 304 Spectrum Central Venous Catheter Trays because the catheters may not fit over the guide wire, potentially causing procedure delays.

    Product
    Spectrum Central Venous Catheter Tray Minocycline/Rifampin Antibiotic Impregnated, Catalog Identifiers: C-UTLMY-501J-ABRM-HC-FST and C-UTLMY-501J-ABRM-HC-IHI-FST Usage: The Spectrum Central Venous Catheter is used for the intravenous administration of nutrient fluids, chemoth
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0632-2018·2018-02-21

    Cook Inc. Recalls Central Venous Catheter Sets Due to Fit Issues

    Cook Inc. is recalling 75 central venous catheter sets because they may not fit over a guide wire, potentially causing procedure delays.

    Product
    Central Venous Catheter Set Heparin Coated Triple Lumen Polyurethane, Catalog Identifiers: C-UTLM-501J-25-6.5-WCE-BH, C-UTLM-501J-BH Product Usage: The central venous catheter is designed for treatment of critically ill patients and is suggested for: 1. Continuous or intermit
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0630-2018·2018-02-21

    Cook Inc. Recalls Central Venous Catheter Sets Due to Fit Issues

    Cook Inc. is recalling 85 Central Venous Catheter Sets because they may not fit over a guide wire, potentially causing procedure delays.

    Product
    Central Venous Catheter Set Triple Lumen Polyurethane, Catalog Identifier: C-UTLM-501J Product Usage: The central venous catheter is designed for treatment of critically ill patients and is suggested for: 1. Continuous or intermittent drug infusions; 2. Central venous blood p
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0633-2018·2018-02-21

    Cook Inc. Recalls Central Venous Catheters Due to Fit Issues

    Cook Inc. is recalling specific lots of Central Venous Tray Triple Lumen Polyurethane Catheters because they may not fit over a guide wire, potentially causing procedure delays.

    Product
    Central Venous Tray Triple Lumen Polyurethane Catheter, Catalog Identifier: C-UTLMY-501J-CCT Product Usage: The central venous catheter is designed for treatment of critically ill patients and is suggested for: 1. Continuous or intermittent drug infusions; 2. Central venous b
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0631-2018·2018-02-21

    Cook Central Venous Catheter Tray Recalled for Fit Issues

    Cook Inc. is recalling 25 Central Venous Catheter Trays because they may not fit over the guide wire, potentially causing procedure delays.

    Product
    Central Venous Catheter Tray Triple Lumen Polyurethane, Catalog Identifier: C-UTLMYJ-501J Product Usage: The central venous catheter is designed for treatment of critically ill patients and is suggested for: 1. Continuous or intermittent drug infusions; 2. Central venous bloo
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2535-2017·2017-06-21

    Cook Inc. Recalls Pereyra Ligature Carrier 75 Due to Reprocessing Instructions

    Cook Inc. is recalling 29 Pereyra Ligature Carrier 75 devices because their reprocessing instructions do not provide sufficient detail for cleaning, disinfection, and sterilization.

    Product
    Pereyra Ligature Carrier 75
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-2585-2017·2017-06-21

    Cook Inc. Recalls OptiLite Multi-Use Holmium Laser Fibers Due to Reprocessing Instructions

    Cook Inc. is voluntarily recalling OptiLite Multi-Use Holmium Laser Fibers because the reprocessing instructions lack sufficient detail for proper cleaning, disinfection, and sterilization.

    Product
    OptiLite Multi-Use Holmium Laser Fibers, Supplied sterilized by ethylene oxide gas in peel-open packages Product Usage: Used with the Odyssey 30 Holmium Laser System for fragmentation of urinary calculi and soft tissue applications including incision/excision, ablation, and
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-2540-2017·2017-06-21

    Cook Inc. Recalls Vue Optic Endoscopes Due to Insufficient Reprocessing Instructions

    Cook Inc. is voluntarily recalling Vue Optic Visualization Sources and Flexor Vue Deflecting Endoscopic Systems because current reprocessing instructions lack sufficient detail for cleaning and sterilization.

    Product
    Vue Optic Visualization Source, Flexor Vue Deflecting Endoscopic System, Endoscope, Fiber Optic, Supplied sterilized by ethylene oxide gas in peel-open packages
    Category
    Medical Device
    Distribution
    6 states
  • ModerateFDA (Devices)·Z-2537-2017·2017-06-21

    Cook Inc. Recalls Clarke-Reich Laparoscopic Knot Pushers Due to Reprocessing Issues

    Cook Inc. is recalling 178 Clarke-Reich Laparoscopic Knot Pushers because the reprocessing instructions do not provide sufficient detail for cleaning, disinfection, and sterilization.

    Product
    Clarke-Reich Laparoscopic Knot Pusher
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • LowFDA (Devices)·Z-2539-2017·2017-06-21

    Cook Multi-Use Holmium Laser Fibers Recalled for Reprocessing Instruction Deficiencies

    Cook Inc. is recalling 4,369 multi-use holmium laser fibers because the current instructions for use do not provide sufficient detail for proper cleaning, disinfection, and sterilization.

    Product
    Cook Multi-Use Holmium Laser Fibers, Supplied sterilized by ethylene oxide gas in peel-open packages
    Category
    Medical Device
    Distribution
    31 states
  • ModerateFDA (Devices)·Z-2310-2017·2017-06-14

    Cook Medical Recalls Willscher Vas Reapproximator Sets Due to Reprocessing Instructions

    Cook Medical is voluntarily recalling Willscher Vas Reapproximator Sets because the reprocessing instructions lack sufficient detail for proper cleaning, disinfection, and sterilization.

    Product
    Willscher Vas Reapproximator Set, Surgical Instrument, Supplied sterilized by ethylene oxide gas in peel-open packages. Used to stabilize the vas ends during microscopic vasovasostomy.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-2315-2017·2017-06-14

    Cook Medical Recalls LapSac Introducer Sets Due to Insufficient Reprocessing Instructions

    Cook Medical is voluntarily recalling 335 LapSac Introducer Sets because the provided reprocessing instructions lack sufficient detail for proper cleaning, disinfection, and sterilization.

    Product
    LapSac Introducer Set, Bag, Extraction, Supplied sterilized by ethylene oxide gas in peel-open packages. Used to aid in the introduction of a LapSac during endoscopic surgical procedures.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-2312-2017·2017-06-14

    Cook Medical Recalls Willscher Vas Reapproximator Plates Due to Reprocessing Instructions

    Cook Medical is voluntarily recalling Willscher Vas Reapproximator Plates because the reprocessing instructions lack sufficient detail for cleaning, disinfection, and sterilization.

    Product
    Willscher Vas Reapproximator Plate, Surgical Instrument, Supplied sterilized by ethylene oxide gas in peel-open packages. Used to stabilize the vas ends during microscopic vasovasostomy.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-2311-2017·2017-06-14

    Cook Medical Recalls Willscher Vas Skewers Due to Insufficient Reprocessing Instructions

    Cook Medical is voluntarily recalling Willscher Vas Skewers because the provided instructions do not contain sufficient detail for proper cleaning, disinfection, and sterilization.

    Product
    Willscher Vas Skewers, Surgical Instrument, Supplied sterilized by ethylene oxide gas in peel-open packages. Used to stabilize the vas ends during microscopic vasovasostomy.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-2314-2017·2017-06-14

    Cook Medical Recalls LapSac Introducers Due to Inadequate Reprocessing Instructions

    Cook Medical is voluntarily recalling LapSac Introducers because the reprocessing instructions do not provide sufficient detailed information for cleaning, disinfection, and sterilization.

    Product
    LapSac Introducer, Supplied sterilized by ethylene oxide gas in peel-open packages. Used to aid in the introduction of a LapSac during endoscopic surgical procedures.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-2313-2017·2017-06-14

    Cook Medical Recalls Endoscopic Curved Needles Due to Reprocessing Instruction Deficiencies

    Cook Medical is voluntarily recalling 725 units of endoscopic curved needles because the reprocessing instructions do not provide sufficient detail for proper cleaning and sterilization.

    Product
    Endoscopic Curved Needle, Surgical Needle Guide, Supplied sterilized by ethylene oxide gas in peel-open packages. Used for internal suturing under direct vision during intraabdominal endoscopic procedures. The needle driver design affords precise placement and control of stand
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1388-2017·2017-03-08

    Cook Inc. Recalls Check-Flo Performer Introducer Sets Due to Blood Loss Risk

    Cook Inc. is recalling 854 Check-Flo Performer Introducer Sets because a specific valve design is associated with increased reports of blood loss.

    Product
    Check-Flo Performer Introducer Set, 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-1392-2017·2017-03-08

    Cook Inc. Recalls Check-Flo Introducer Devices Due to Blood Loss Reports

    Cook Inc. is recalling 29 Check-Flo Introducer Hausdorf-Lock Atrial devices worldwide due to increased reports of blood loss associated with the hemostatic valve design.

    Product
    Check-Flo Introducer Hausdorf-Lock Atrial, 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-1393-2017·2017-03-08

    Cook Inc. Recalls TriForce Peripheral Crossing Sets Due to Blood Loss Reports

    Cook Inc. is recalling 1,875 TriForce Peripheral Crossing Sets because a specific valve design is associated with increased reports of blood loss.

    Product
    TriForce Peripheral Crossing Set, Individual product is packaged in a Tyvek-film sterilizable outer pouch. The TriForce Peripheral Crossing Set is intended to be percutaneously introduced into blood vessels and support a wire guide while performing percutaneous peripheral interv
    Category
    Medical Device
    Distribution
    46 states
  • HighFDA (Devices)·Z-1391-2017·2017-03-08

    Cook Inc. Recalls Micropuncture Check-Flo Performer Introducer Sets Due to Blood Loss

    Cook Inc. is recalling 778 Micropuncture Check-Flo Performer Introducer Sets because a specific valve design is associated with increased reports of blood loss.

    Product
    Micropuncture Check-Flo Performer Introducer Set, 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