Cook, Inc.
264 recalls on record · Latest: Dec 29, 2021
Cook, Inc. Recall Insight
Cook, Inc. appears on 264 federal recall records indexed by PlainRecalls, out of 101,704 total recalls tracked across the FDA, CPSC, and NHTSA. That represents approximately 0.260% of the federal archive, a data point that is only interpretable alongside production volume, product mix, and decades of operation, because a high recall count alone does not establish fault. Large, diversified firms that sell tens of millions of units across many categories will mechanically accumulate more recall records than small manufacturers, even when their defect rates per unit shipped are comparable or lower. The most recent action on this firm is dated Dec 29, 2021, which is the anchor point for assessing whether enforcement is currently active or historical.
On this page of 50 entries, severity tagging shows 3 critical, 47 moderate, and 0 lower-severity recalls. Affected-unit counts are disclosed on 50 of 50 entries, unit-count disclosure is more common on CPSC and NHTSA actions and less common on FDA drug/device recalls, where lot numbers and distribution scope substitute for absolute totals. The records on this page span 1 distinct product categories, with issuing agencies dominated by FDA Devices (50). The date window on this page runs from Mar 2, 2016 to Mar 7, 2018.
Manufacturer-level browsing is useful when monitoring a single firm for patterns, whether recalls cluster around one product family (suggesting a specific design or supplier issue) or scatter across the firm's entire catalog (which can indicate systemic quality-control problems or deliberate regulator attention). Clicking into each recall reveals the specific hazard, remedy, and distribution scope that together determine whether a consumer is actually at risk. For decisions that depend on being current, deciding whether a product in your home is safe, whether to return a gift, or whether to accept a replacement, always verify the recall number on the issuing agency's site, because federal agencies amend, terminate, and re-scope recalls over time and only the agency's live record reflects the current legal status. This page aggregates what agencies have published publicly and is intended for consumer awareness and research.
Wills-Oglesby Percutaneous Gastrostomy Set Product Usage: Intended for the percutaneous placement of a catheter for gastroenteric feeding
Central Venous Tray Triple Lumen Polyurethane Catheter, Catalog Identifier: C-UTLMY-501J-CCT Product Usage: The central venous catheter is design…
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…
Central Venous Catheter Set Triple Lumen Polyurethane, Catalog Identifier: C-UTLM-501J Product Usage: The central venous catheter is designed for…
Central Venous Catheter Tray Triple Lumen Polyurethane, Catalog Identifier: C-UTLMYJ-501J Product Usage: The central venous catheter is designed …
Spectrum Central Venous Catheter Tray Minocycline/Rifampin Antibiotic Impregnated, Catalog Identifiers: C-UTLMY-501J-ABRM-HC-FST and C-UTLMY-501J-ABR…
Clarke-Reich Laparoscopic Knot Pusher
Stamey Needle
Endoscopic Introducer/Extractor
Pereyra-Raz Ligature Carrier
OptiLite Multi-Use Holmium Laser Fibers, Supplied sterilized by ethylene oxide gas in peel-open packages Product Usage: Used with the Odyssey 30…
Cook Multi-Use Holmium Laser Fibers, Supplied sterilized by ethylene oxide gas in peel-open packages
Vue Optic Visualization Source, Flexor Vue Deflecting Endoscopic System, Endoscope, Fiber Optic, Supplied sterilized by ethylene oxide gas in peel-op…
Pereyra Ligature Carrier 75
Willscher Vas Reapproximator Set, Surgical Instrument, Supplied sterilized by ethylene oxide gas in peel-open packages. Used to stabilize the vas …
LapSac Introducer, Supplied sterilized by ethylene oxide gas in peel-open packages. Used to aid in the introduction of a LapSac during endoscopic …
Willscher Vas Reapproximator Plate, Surgical Instrument, Supplied sterilized by ethylene oxide gas in peel-open packages. Used to stabilize the va…
LapSac Introducer Set, Bag, Extraction, Supplied sterilized by ethylene oxide gas in peel-open packages. Used to aid in the introduction of a LapS…
Willscher Vas Skewers, Surgical Instrument, Supplied sterilized by ethylene oxide gas in peel-open packages. Used to stabilize the vas ends during…
Endoscopic Curved Needle, Surgical Needle Guide, Supplied sterilized by ethylene oxide gas in peel-open packages. Used for internal suturing under…
Bush DL Ureteral Illuminating Catheter Set Bush SL Ureteral Illuminating Catheter Set
Micropuncture Check-Flo Performer Introducer Set, Individual product is packaged in a Tyvek-film sterilizable outer pouch. Introducers are intended …
TriForce Peripheral Crossing Set, Individual product is packaged in a Tyvek-film sterilizable outer pouch. The TriForce Peripheral Crossing Set is i…
Check-Flo Hemostasis Assembly, Individual product is packaged in a Tyvek-film sterilizable outer pouch.
Check-Flo Performer Introducer, Individual product is packaged in a Tyvek-film sterilizable outer pouch. Introducers are intended for introduction o…
Check-Flo Performer Introducer Set, Individual product is packaged in a Tyvek-film sterilizable outer pouch. Introducers are intended for introducti…
Check-Flo Introducer Hausdorf-Lock Atrial, Individual product is packaged in a Tyvek-film sterilizable outer pouch. Introducers are intended for int…
Flexor Radial Access Set, Individual product is packaged in a Tyvek-film sterilizable outer pouch. The Flexor¿ Radial Hydrophilic Introducer Access …
Cook Spectrum Minocycline/Rifampin Impregnated Double Lumen Central Venous Catheter Tray Cook Spectrum Minocycline/Rifampin Impregnated Triple Lumen…
Neff DAgostino Percutaneous Access Set Accessories, Catheter Intended for single-puncture percutaneous access to facilitate placement of an .038 in…
Aprima Access Nonvascular Introducer Set Accessories, Catheter Intended for single-puncture percutaneous access to facilitate placement of an .038 …
Shuttle Select Slip-Cath Catheter, Intravascular, Diagnostic The catheters are intended for use in angiographic procedures by physicians trained an…
Beacon Tip Royal Flush Plus High-Flow Catheter Catheter, Intravascular, Diagnostic The catheters are intended for use in angiographic procedures by…
FluoroSet Radiographic Tubal Assessment Set Cannula, Manipulator/ Injector, Uterine Used for instillation of contrast media into the uterine cavity…
Beacon Tip Torcon NB Advantage Catheter Catheter, Intravascular, Diagnostic
Kumpe Access Catheter Cathether, Ureteral, General & Plastic Surgery Used in combination with a HiWire, Bentson, or other flexible-tipped wire guid…
Haskal Transjugular Intrahepatic Portal Access Set Introducer, catheter Intended for transjugular liver access in diagnostic and interventional pro…
Roadrunner Uniglide Hydrophilic Wire Guide, Catalog Numbers and GPN: HPWA-18-260, G30489; HPWA-18-320, G30490; HPWA-25-260, G30491; HPWA-35-260, G304…
Beacon Tip Centimeter Sizing Catheter Beacon Tip White Vessel Sizing Catheter Beacon Tip Vessel Sizing Catheter Catheter, Intravascular, Diagnos…
Liver Access and Biopsy Needle Set Biopsy needle kit Intended for use in obtaining liver histology samples via a jugular vein approach.
Selective Salpingography Catheter with Beacon Tip Cannula, Manipulator/ Injector, Uterine Used for injection of contrast medium into the fallopian …
Slip-Cath Beacon Tip Catheter Catheter, Intravascular, Diagnostic The catheters are intended for use in angiographic procedures by physicians train…
Transluminal Biliary Biopsy Forceps Set Forceps, Biopsy, Non-Electric Intended for access to and biopsy of tissue within the biliary ductal system
White Lumax Guiding Coaxial Catheter Catheter, Percutaneous Intended for the delivery of angioplasty balloons and other types of interventional dev…
Ascend¿ AQ¿ Ureteral Dilation Balloon Catheter Set The Ascend¿ AQ¿ Ureteral Dilation Balloon Catheter Set consists of a radiopaque balloon catheter …
UltraxxTM Nephrostomy Balloon Set The Ultraxx" Nephrostomy Balloon Set consists of a radiopaque balloon catheter, radiopaque sheath, and inflation d…
Kopans Breast Lesion Localization Needle The Kopans Breast Lesion Localization Needle consists of a bevel-tip needle with centimeter markings and a …
Flexor Check-Flo Introducer, Catheter introducer, Catalog #: KCFW-6.0-35-70-RB-HFANL0-HC Intended for introduction of balloons, closed and non-t…
Single Lumen Pressure Monitoring Sets and Trays The subject sets and trays are comprised of a single-lumen uncoated or heparin-coated catheter. Pr…
Shuttle Select Slip-Cath Catheter. Angiographic catheter. For use in angiographic procedures as a conduit for the delivery of contrast media and …
Nearby Manufacturers
Other firms with recall activity tracked in the PlainRecalls index.
Data Sources
Every figure on PlainRecalls is rendered directly from official FDA, CPSC and NHTSA recall records, no number is typed in by an editor. Recalls are aggregated across FDA, CPSC and NHTSA filings that name this firm; the total reflects the federal record, not an independent investigation. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error. Data current as of July 2026.