Manufacturer

Cook Incorporated

85 recalls in our database name Cook Incorporated as the manufacturing or recalling firm.

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.

1–25 of 85

CriticalFDA (Devices)·Z-1935-2026·2026-05-13
Aurous Centimeter Sizing Catheter Recalled for Marker Band Cracking Risk
Cook Incorporated is recalling Aurous Centimeter Sizing Catheters due to risk of marker band cracking or breakage during angiographic procedures. Potential complications include device fragmentation, vessel injury, and in worst-case scenarios, life-threatening harm or death.
Product
Aurous Centimeter Sizing Catheter RPN N5.0-35-100-P-10S-PIG-CSC-20-01 GPN G47308 Sizing catheters are single-use, sterile catheters with gold marker bands. These catheters are for use in angiographic procedures and available in a variety of lengths (70 and 100 cm) and tip co
Category
Medical Device
Distribution
Distributed nationwide
CriticalFDA (Devices)·Z-1934-2026·2026-05-13
Cook Centimeter Sizing Catheter recall due to marker band cracking
Cook Incorporated is recalling Centimeter Sizing Catheters because marker bands may crack or break, potentially causing device fragmentation, vessel injury, or life-threatening harm.
Product
Centimeter Sizing Catheter RPN N5.0-35-100-P-10S-PIG-CSC-20 GPN G11916 Catheters for use in angiographic procedures are available in a variety of French sizes, endhole sizes, lengths, materials and designs (e.g., polyethylene or nylon, non-braided or braided with 1:1 torque)
Category
Medical Device
Distribution
Distributed nationwide
SevereFDA (Devices)·Z-1936-2026·2026-05-13
Beacon Tip Centimeter Sizing Catheter recalled for cracking marker bands
Cook Incorporated is recalling Beacon Tip Centimeter Sizing Catheters because marker bands may crack or break, which could lead to device fragmentation, prolonged procedures, vessel injury, and in worst-case scenarios, life-threatening harm or death.
Product
Beacon Tip Centimeter Sizing Catheter RPN/GPN NR5.0-35-70-P-10S-0-CSC-20 G31213 NR5.0-35-100-P-10S-0-CSC-20 G31214 NR5.0-35-100-P-10S-PIG-CSC-20 G31216 NR5.0-35-70-P-10S-VCF-CSC-20 G31220 NR5.0-35-100-P-10S-VCF-CSC-20 G31221 Sizing catheters are single-use, sterile
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1782-2026·2026-04-15
Cook Staged Extubation Sets Recalled for Mislabeled Expiration Dates
Cook Incorporated is recalling 95 Cook Staged Extubation Sets worldwide because the devices are labeled with expiration dates that exceed their actual shelf life. Using an expired device could compromise its sterility and safety.
Product
COOK MEDICAL Cook Staged Extubation Set: Reference Part Number C-CAE-14.0-83-EXTU, Order Number G24073
Category
Medical Device
Distribution
0 states
HighFDA (Devices)·Z-1788-2026·2026-04-15
Cook Medical Spectrum Central Venous Catheter Sets Mislabeled With Expiration Dates
Cook Medical Spectrum Central Venous Catheter Sets in affected lots were labeled with expiration dates that exceed the true shelf life. These devices may be used beyond the point when they have actually expired.
Product
COOK MEDICAL Spectrum¿ Central Venous Catheter Set: Reference Part Number C-UDLM-401J-ABRM-HC, Order Number G43983; Reference Part Number C-UDLM-401J-ABRM-HC-CAH, Order Number G24754; Reference Part Number C-UDLM-401J-LSC-ABRM-HC, Order Number G43986; Reference Part Number
Category
Medical Device
Distribution
0 states
HighFDA (Devices)·Z-1779-2026·2026-04-15
Cook Medical Tracheostomy Introducer Sets Labeled with Incorrect Expiration Dates
Cook Medical has recalled 916 units of Blue Rhino G2-Multi Percutaneous Tracheostomy Introducer Sets worldwide because the labels show expiration dates that exceed the true shelf life of the devices.
Product
COOK MEDICAL Blue Rhino G2-Multi Percutaneous Tracheostomy Introducer Set: Reference Part Number C-PTIS-100-HC-G-EU, Order Number G57685; Reference Part Number C-PTIS-100-HC-G-NA, Order Number G57682; Reference Part Number C-PTIS-100-UNL-HC-G-EU, Order Number G57687; Refer
Category
Medical Device
Distribution
0 states
HighFDA (Devices)·Z-1783-2026·2026-04-15
Cook Spectrum Central Venous Catheter Tray Recalled for Incorrect Expiration Dates
Cook Incorporated recalled 1,872 Cook Spectrum Central Venous Catheter Trays with incorrect expiration date labeling. Products were labeled with expiration dates exceeding their true shelf life.
Product
COOK MEDICAL Cook¿ Spectrum¿ Central Venous Catheter Tray: Reference Part Number C-UTLMY-701J-ABRM-CUSTOM-0003, Order Number G56424; Reference Part Number C-UTLMY-701J-ABRM-CUSTOM-0018, Order Number G21053; Reference Part Number C-UTLMY-701J-ABRM-CUSTOM-0042, Order Number G3
Category
Medical Device
Distribution
0 states
HighFDA (Devices)·Z-1786-2026·2026-04-15
Multipurpose Drainage Catheter Recalled for Mislabeled Expiration Dates
Cook Medical recalls drainage catheters with mislabeled expiration dates that exceed actual shelf life. Affected units may degrade before the labeled expiration date.
Product
COOK MEDICAL Multipurpose Drainage Catheter: Reference Part Number ULT8.5-38-25-P-CLMS-8-RH-FS, Order Number G29775
Category
Medical Device
Distribution
0 states
HighFDA (Devices)·Z-1787-2026·2026-04-15
Cook Medical NCompass Nitinol Stone Extractor: Incorrect Expiration Dating
Cook Medical is recalling certain NCompass Nitinol Stone Extractor units with expiration dates exceeding true shelf life. Affected healthcare providers should discontinue use and contact the manufacturer.
Product
COOK MEDICAL NCompass¿ Nitinol Stone Extractor: Reference Part Number C-NTSE-2.4-115-NC3, Order Number G36250; Reference Part Number C-NTSE-2.4-115-NCT4, Order Number G36251.
Category
Medical Device
Distribution
0 states
HighFDA (Devices)·Z-1777-2026·2026-04-15
Cook Medical Micro Wire Guide: Mislabeled Expiration Dates Exceed True Shelf Life
Cook Medical is recalling the Approach CTO-18 Micro Wire Guide due to mislabeled expiration dates that exceed the product's actual shelf life. The recall affects 75 units distributed worldwide.
Product
COOK MEDICAL Approach CTO-18 Micro Wire Guide, Reference Part Number CMW-14-190-18G, Order Number G50788; Reference Part Number CMW-14-300-18G, Order Number G50792
Category
Medical Device
Distribution
0 states
HighFDA (Devices)·Z-1785-2026·2026-04-15
Emergency Cricothyrotomy Catheter Set Expiration Dates Exceed True Shelf Life
Cook Incorporated is recalling the Melker Universal Cuffed Emergency Cricothyrotomy Catheter Set because the labeled expiration dates exceed the devices' true shelf life. The recall affects 476 units distributed worldwide.
Product
Melker Universal Cuffed Emergency Cricothyrotomy Catheter Set: Reference Part Number C-TCCSB-500-UNI, Order Number G32193; Reference Part Number C-TCCSB-500-UNI-01, Order Number G47665.
Category
Medical Device
Distribution
0 states
HighFDA (Devices)·Z-1778-2026·2026-04-15
Cook Medical Arterial Pressure Monitoring Trays Mislabeled With Extended Expiration Dates
Cook Incorporated is recalling Arterial Pressure Monitoring Trays because the devices are labeled with expiration dates beyond their actual shelf life, creating a risk if used past their true expiration.
Product
COOK MEDICAL Arterial Pressure Monitoring Tray, Reference Part Number APMY-2.5-15-0-2.5 , Order Number G58412; Reference Part Number APMY-4.0-21J-1-12, Order Number G58419
Category
Medical Device
Distribution
0 states
HighFDA (Devices)·Z-1780-2026·2026-04-15
Cook Medical Tracheostomy Introducer Tray Labeled with Excessive Expiration Dates
Cook Medical is recalling 441 units of its Blue Rhino G2-Multi Percutaneous Tracheostomy Introducer Tray, which were labeled with expiration dates exceeding the actual shelf life. The recalled devices were distributed worldwide.
Product
COOK MEDICAL Blue Rhino¿ G2-Multi Percutaneous Tracheostomy Introducer Tray: Reference Part Number C-PTISY-100-HC-G-NA, Order Number G57703; Reference Part Number C-PTISY-100-UNL-HC-G-NA, Order Number G57706; Reference Part Number C-PTISY-100-UNS-HC-G-NA, Order Number G57704
Category
Medical Device
Distribution
0 states
HighFDA (Devices)·Z-1791-2026·2026-04-15
Cook Medical Wayne Pneumothorax Set expiration dates exceed true shelf life
Cook Medical's Wayne Pneumothorax Set has incorrect labeling on 104 units. Products are labeled with expiration dates that exceed their true shelf life.
Product
COOK MEDICAL Wayne Pneumothorax Set: Reference Part Number C-UTPT-1020-WAYNE-IMH, Order Number G56532; Reference Part Number C-UTPT-1400-WAYNE-112497-IMH, Order Number G56535.
Category
Medical Device
Distribution
0 states
HighFDA (Devices)·Z-1781-2026·2026-04-15
Cook Medical Percutaneous Tracheostomy Sets Mislabeled with Expiration Dates
Cook Incorporated is recalling 484 percutaneous tracheostomy introducer sets with mislabeled expiration dates that exceed true shelf life, distributed worldwide to healthcare facilities.
Product
COOK MEDICAL Ciaglia Blue Rhino Percutaneous Tracheostomy Introducer Set: Reference Part Number C-PTIS-100-FLEX-HC, Order Number G32092; Reference Part Number C-PTIS-100-HC, Order Number G12115.
Category
Medical Device
Distribution
0 states
HighFDA (Devices)·Z-1792-2026·2026-04-15
COOK MEDICAL Wayne Pneumothorax Tray: Incorrect Expiration Date Labeling
Cook Medical issued a Class II recall of 318 Wayne Pneumothorax Trays distributed worldwide because the devices were labeled with expiration dates exceeding their true shelf life.
Product
COOK MEDICAL Wayne Pneumothorax Tray: Reference Part Number C-UTPTY-1400-WAYNE-112497-IMH, Order Number G56537; Reference Part Number C-UTPTY-1400-WAYNE-112497-IMH, Order Number G56537; Reference Part Number C-UTPTY-1400-WAYNE-112497-IMH, Order Number G56537; Reference Par
Category
Medical Device
Distribution
0 states
HighFDA (Devices)·Z-1775-2026·2026-04-15
COOK MEDICAL Micro Wire Guide Recalled for Mislabeled Expiration Dates
COOK MEDICAL has recalled 15 units of its Approach CTO-6 Micro Wire Guide (lot 15288005) because the labeled expiration dates exceed the actual shelf life of the devices. These devices were distributed worldwide.
Product
COOK MEDICAL Approach CTO-6 Micro Wire Guide, Reference Part Number CMW-14-190-6G, Order Number G50786
Category
Medical Device
Distribution
0 states
HighFDA (Devices)·Z-1790-2026·2026-04-15
COOK MEDICAL Chest Tube Tray Recalled for Mislabeled Expiration Dates
COOK MEDICAL Thal-Quick Chest Tube Trays were labeled with expiration dates exceeding their true shelf life. The worldwide recall affects two specific lot numbers.
Product
COOK MEDICAL Thal-Quick Chest Tube Tray: Reference Part Number C-TQTSY-3200, Order Number G07242
Category
Medical Device
Distribution
0 states
HighFDA (Devices)·Z-1789-2026·2026-04-15
COOK Spectrum Central Venous Trays recalled for overstated expiration dates
Cook Incorporated is recalling certain COOK Spectrum Central Venous Trays that are labeled with expiration dates exceeding their actual shelf life, creating risks of compromised sterility and device degradation.
Product
COOK MEDICAL Spectrum¿ Central Venous Tray: Reference Part Number C-UQLMYJ-1001J-RSC-ABRM-HC-FST-A-RD, Order Number G44800; Reference Part Number C-UTLMYJ-701J-ABRM-HC-IHI-FST-A-RD, Order Number G44809; Reference Part Number C-UTLMYJ-701J-RSC-ABRM-HC-FST-A-RD, Order Number G
Category
Medical Device
Distribution
0 states
ModerateFDA (Devices)·Z-1784-2026·2026-04-15
Bile Duct Exploration Sets Recalled for Incorrect Expiration Date Labels
Cook Incorporated is recalling 49 units of its Strange Bile Duct Stone Exploration Set due to incorrect expiration dates on product labels that exceed the true shelf life.
Product
COOK MEDICAL Cook¿ Strange Bile Duct Stone Exploration Set: Reference Part Number C-CSRC-7.5D-40-STRANGE, Order Number G09108
Category
Medical Device
Distribution
0 states
ModerateFDA (Devices)·Z-1776-2026·2026-04-15
Cook Medical Catheter Guidewire Recall for Incorrect Expiration Dates
Cook Incorporated is recalling COOK MEDICAL Approach CTO-12 Micro Wire Guides due to incorrect expiration dating on device labels. The labeled expiration dates exceed the true shelf life.
Product
COOK MEDICAL Approach CTO-12 Micro Wire Guide: Reference Part Number CMW-14-190-12G, Order Number G50787; Reference Part Number CMW-14-300-12G, Order Number G50791
Category
Medical Device
Distribution
0 states
HighFDA (Devices)·Z-0995-2026·2025-12-31
Rosch-Uchida Transjugular Liver Access Sets recalled for manufacturing defects
Cook Incorporated is recalling 23 units of Rosch-Uchida Transjugular Liver Access Sets due to manufacturing specification defects. Devices may have been cut to incorrect lengths, improperly trimmed, or inadequately inspected.
Product
R¿sch-Uchida Transjugular Liver Access Sets, Reference Part Numbers: RUPS-100; The R¿sch-Uchida Transjugular Liver Access Set is intended for transjugular liver access in diagnostic and interventional procedures.
Category
Medical Device
Distribution
0 states
HighFDA (Devices)·Z-0994-2026·2025-12-31
Cook Ring Transjugular Intrahepatic Access Sets Recalled for Manufacturing Defects
Cook Incorporated is recalling 15 units of Ring Transjugular Intrahepatic Access Sets due to manufacturing defects. Affected devices may have been cut to incorrect length, improperly trimmed, and inadequately inspected.
Product
Ring Transjugular Intrahepatic Access Sets, Reference Part Numbers: 1) RTPS-100; 2) RTPS-100-10.0; The Ring Transjugular Intrahepatic Access Set is intended for transjugular liver access in diagnostic and interventional procedures.
Category
Medical Device
Distribution
0 states
HighFDA (Devices)·Z-0993-2026·2025-12-31
Flexor Check-Flo Introducers and Sets Recalled for Manufacturing Defects
Cook Medical is recalling Flexor Check-Flo Introducers and Sets due to manufacturing defects. Affected products may have been cut to incorrect lengths, improperly trimmed, or inadequately inspected.
Product
Flexor Check-Flo Introducers and Sets, Reference Part Numbers: 1) KCFW-9.0-18/38-45-RB-ANL0-HC; 2) KCFW-9.0-18/38-45-RB-ANL1-HC; 3) KCFW-10.0-35-45-RB-HFANL0-HC; 4) KCFW-10.0-35-45-RB-HFANL1-HC; 5) KCFW-12.0-35-45-RB-HFANL0-HC; 6) KCFW-12.0-35-45-RB-HFANL1-HC; 7) K
Category
Medical Device
Distribution
0 states
SevereFDA (Devices)·Z-1902-2025·2025-06-25
Beacon Tip 5.0 Fr Angiographic Catheters Recalled for Potential Tip Separation
Cook Incorporated recalled Beacon Tip 5.0 Fr angiographic catheters because the catheter tip may separate during use. The recall affects 26,986 units distributed worldwide.
Product
Beacon Tip 5.0 Fr Angiographic catheters are designed to facilitate diagnostic and therapeutic procedures. Catheters are available in various configurations. Configurations include different shaft lengths and tip curves and some catheters are manufactured with a hydrophilic coati
Category
Medical Device
Distribution
0 states