PlainRecalls

Cook Inc.

188 recalls on record · Latest: Dec 29, 2021

Cook Inc. Recall Insight

Cook Inc. appears on 188 federal recall records indexed by PlainRecalls, out of 83,949 total recalls tracked across the FDA, CPSC, NHTSA, and USDA FSIS. That represents approximately 0.224% 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 38 entries, severity tagging shows 8 critical, 30 moderate, and 0 lower-severity recalls. Affected-unit counts are disclosed on 38 of 38 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 (38). The date window on this page runs from May 22, 2013 to Feb 21, 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.

FDA Devices Moderate Feb 21, 2018

Central Venous Tray Triple Lumen Polyurethane Catheter, Catalog Identifier: C-UTLMY-501J-CCT Product Usage: The central venous catheter is design…

FDA Devices Moderate Feb 21, 2018

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…

FDA Devices Moderate Jun 21, 2017

Clarke-Reich Laparoscopic Knot Pusher

FDA Devices Moderate Jun 21, 2017

Stamey Needle

FDA Devices Moderate Jun 21, 2017

Endoscopic Introducer/Extractor

FDA Devices Moderate Jun 21, 2017

Pereyra-Raz Ligature Carrier

FDA Devices Moderate Jun 21, 2017

OptiLite Multi-Use Holmium Laser Fibers, Supplied sterilized by ethylene oxide gas in peel-open packages Product Usage: Used with the Odyssey 30…

FDA Devices Moderate Jun 21, 2017

Cook Multi-Use Holmium Laser Fibers, Supplied sterilized by ethylene oxide gas in peel-open packages

FDA Devices Moderate Jun 14, 2017

Willscher Vas Reapproximator Set, Surgical Instrument, Supplied sterilized by ethylene oxide gas in peel-open packages. Used to stabilize the vas …

FDA Devices Moderate Jun 14, 2017

LapSac Introducer, Supplied sterilized by ethylene oxide gas in peel-open packages. Used to aid in the introduction of a LapSac during endoscopic …

FDA Devices Moderate Jun 14, 2017

Willscher Vas Reapproximator Plate, Surgical Instrument, Supplied sterilized by ethylene oxide gas in peel-open packages. Used to stabilize the va…

FDA Devices Moderate Mar 8, 2017

Micropuncture Check-Flo Performer Introducer Set, Individual product is packaged in a Tyvek-film sterilizable outer pouch. Introducers are intended …

FDA Devices Moderate Mar 8, 2017

TriForce Peripheral Crossing Set, Individual product is packaged in a Tyvek-film sterilizable outer pouch. The TriForce Peripheral Crossing Set is i…

FDA Devices Moderate Mar 8, 2017

Check-Flo Hemostasis Assembly, Individual product is packaged in a Tyvek-film sterilizable outer pouch.

FDA Devices Moderate Mar 8, 2017

Check-Flo Performer Introducer, Individual product is packaged in a Tyvek-film sterilizable outer pouch. Introducers are intended for introduction o…

FDA Devices Moderate Mar 8, 2017

Check-Flo Performer Introducer Set, Individual product is packaged in a Tyvek-film sterilizable outer pouch. Introducers are intended for introducti…

FDA Devices Moderate Mar 8, 2017

Check-Flo Introducer Hausdorf-Lock Atrial, Individual product is packaged in a Tyvek-film sterilizable outer pouch. Introducers are intended for int…

FDA Devices Moderate Aug 31, 2016

Neff DAgostino Percutaneous Access Set Accessories, Catheter Intended for single-puncture percutaneous access to facilitate placement of an .038 in…

FDA Devices Moderate Aug 31, 2016

Aprima Access Nonvascular Introducer Set Accessories, Catheter Intended for single-puncture percutaneous access to facilitate placement of an .038 …

FDA Devices Moderate Aug 31, 2016

Shuttle Select Slip-Cath Catheter, Intravascular, Diagnostic The catheters are intended for use in angiographic procedures by physicians trained an…

FDA Devices Moderate Aug 31, 2016

Beacon Tip Royal Flush Plus High-Flow Catheter Catheter, Intravascular, Diagnostic The catheters are intended for use in angiographic procedures by…

FDA Devices Moderate Aug 31, 2016

FluoroSet Radiographic Tubal Assessment Set Cannula, Manipulator/ Injector, Uterine Used for instillation of contrast media into the uterine cavity…

FDA Devices Moderate Aug 31, 2016

Beacon Tip Torcon NB Advantage Catheter Catheter, Intravascular, Diagnostic

FDA Devices Moderate Mar 30, 2016

Ascend¿ AQ¿ Ureteral Dilation Balloon Catheter Set The Ascend¿ AQ¿ Ureteral Dilation Balloon Catheter Set consists of a radiopaque balloon catheter …

FDA Devices Moderate Mar 9, 2016

Kopans Breast Lesion Localization Needle The Kopans Breast Lesion Localization Needle consists of a bevel-tip needle with centimeter markings and a …

FDA Devices Moderate Mar 2, 2016

Flexor Check-Flo Introducer, Catheter introducer, Catalog #: KCFW-6.0-35-70-RB-HFANL0-HC Intended for introduction of balloons, closed and non-t…

FDA Devices Critical Mar 2, 2016

Single Lumen Pressure Monitoring Sets and Trays The subject sets and trays are comprised of a single-lumen uncoated or heparin-coated catheter. Pr…

FDA Devices Critical Mar 2, 2016

Shuttle Select Slip-Cath Catheter. Angiographic catheter. For use in angiographic procedures as a conduit for the delivery of contrast media and …

FDA Devices Critical Mar 2, 2016

Femoral Artery Pressure Monitoring Catheter Sets and Trays The subject sets and trays are comprised of a single-lumen uncoated or heparin-coated c…

FDA Devices Moderate Dec 23, 2015

VentriClear¿ II Ventricular Drainage Catheter Set. Allows external access and drainage of cerebrospinal fluid (CSF) from the ventricles of the brain.

FDA Devices Moderate Nov 18, 2015

Cook Medical CXI Support Catheter 2.6FR curved catheter and 4.0FR straight catheter, for cardiovascular use.

FDA Devices Critical Aug 12, 2015

Beacon Tip Royal Flush Plus High-Flow Catheter. Angiographic catheter. For use in angiographic procedures as a conduit for the delivery of cont…

FDA Devices Critical Aug 12, 2015

Slip-Cath Beacon Tip Catheter. Angiographic catheter. For use in angiographic procedures as a conduit for the delivery of contrast media and ca…

FDA Devices Critical Aug 12, 2015

Beacon Tip Torcon NB Advantage Catheter. Angiographic catheter. For use in angiographic procedures as a conduit for the delivery of contrast medi…

FDA Devices Moderate Jul 29, 2015

Ring Transjugular Intrahepatic Access Set Product Usage: The Ring Transjugular Intrahepatic Access Sets are intended for transjugular liver acces…

FDA Devices Moderate Jul 1, 2015

LapSac Surgical Tissue Pouch. The current intended use for the LapSac Surgical Tissue Pouch is for isolating tissue during, or prior to, surgical…

FDA Devices Critical Sep 3, 2014

CloverSnare 4-Loop Vascular Retrieval Snare. Product is packaged in a Tyvek-film sterilizable outer package and is supplied one pouch in a box. T…

FDA Devices Critical May 22, 2013

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 s…

Nearby Manufacturers

Other firms with recall activity tracked in the PlainRecalls index.

Compare Cook Inc. with FORD →

Data Sources

  • Source: FDA + CPSC + NHTSA + USDA FSIS — federal recall filings naming this firm. Verify with FDA, CPSC, NHTSA, or USDA FSIS directly.
  • Source: PlainRecalls Manufacturer Index — firm-level aggregation across all four federal recall feeds