The Recall Desk

Manufacturer

Cook Incorporated

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

What the numbers show

Total
85
Critical
2
Severe
4
Most recent
2026-05-13

Of the 85 recalls from Cook Incorporated we have scored against our rubric, 2 (2%) are Critical — deaths or serious injuries reported, or the agency’s own highest classification — and 4 (5%) 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.

1–25 of 85

  • 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
  • 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
  • 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-1791-2026·2026-04-15

    Cook Medical Wayne pneumothorax sets carry overstated expiration dates

    Cook Medical is recalling Wayne Pneumothorax Sets because affected lots were labeled with expiration dates that exceed the product's true shelf life. 104 units are affected.

    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-1778-2026·2026-04-15

    Cook Medical arterial pressure monitoring trays carry overstated expiration dates

    Cook Medical is recalling Arterial Pressure Monitoring Trays because affected lots were labeled with expiration dates that exceed the product's true shelf life. 20 units are affected.

    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-1789-2026·2026-04-15

    Cook Medical Spectrum central venous trays carry overstated expiration dates

    Cook Medical is recalling Spectrum Central Venous Trays because affected lots were labeled with expiration dates that exceed the product's true shelf life. 2,348 units are affected.

    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
  • HighFDA (Devices)·Z-1780-2026·2026-04-15

    Blue Rhino G2-Multi tracheostomy introducer trays carry overstated expiration dates

    Cook Medical is recalling Blue Rhino G2-Multi Percutaneous Tracheostomy Introducer Trays because affected lots were labeled with expiration dates that exceed the true shelf life. 441 units are affected.

    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-1790-2026·2026-04-15

    Cook Medical chest tube tray labeled with an overstated expiration date

    Cook Medical is recalling Thal-Quick Chest Tube Trays because affected lots were labeled with expiration dates that exceed the product's true shelf life. Two units are affected.

    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-1777-2026·2026-04-15

    Cook Medical CTO-18 wire guides labeled with overstated expiration dates

    Cook Medical is recalling Approach CTO-18 Micro Wire Guides because affected lots were labeled with expiration dates that exceed the product's true shelf life. 75 units are affected.

    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

    Cricothyrotomy catheter sets labeled with overstated expiration dates

    Cook Incorporated is recalling Melker Universal Cuffed Emergency Cricothyrotomy Catheter Sets because affected lots were labeled with expiration dates that exceed the true shelf life.

    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-1792-2026·2026-04-15

    Cook Medical pneumothorax tray labeled with an overstated expiration date

    Cook Medical is recalling Wayne Pneumothorax Trays because affected lots were labeled with expiration dates that exceed the product's true shelf life. 318 units are affected.

    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-1781-2026·2026-04-15

    Cook Medical tracheostomy introducer sets labeled with overstated expiration dates

    Cook Medical is recalling Ciaglia Blue Rhino Percutaneous Tracheostomy Introducer Sets because affected lots were labeled with expiration dates that exceed the true shelf life. 484 units are affected.

    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-1783-2026·2026-04-15

    Cook Medical Spectrum central venous catheter trays carry overstated expiration dates

    Cook Medical is recalling custom Spectrum Central Venous Catheter Trays because affected lots were labeled with expiration dates that exceed the true shelf life. 1,872 units are affected.

    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-1788-2026·2026-04-15

    Cook Medical central venous catheter sets labeled with overstated expiration dates

    Cook Medical is recalling Spectrum Central Venous Catheter Sets because affected lots were labeled with expiration dates that exceed the product's true shelf life. 5,080 units are affected.

    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-1786-2026·2026-04-15

    Cook Medical multipurpose drainage catheters carry overstated expiration dates

    Cook Medical is recalling a Multipurpose Drainage Catheter because affected lots were labeled with expiration dates that exceed the product's true shelf life. 20 units are affected.

    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-1782-2026·2026-04-15

    Cook Medical extubation set labeled with an overstated expiration date

    Cook Medical is recalling Staged Extubation Sets because affected lots were labeled with expiration dates that exceed the product's true shelf life. 95 units are affected.

    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-1787-2026·2026-04-15

    Cook Medical nitinol stone extractors labeled with overstated expiration dates

    Cook Medical is recalling NCompass Nitinol Stone Extractors because affected lots were labeled with expiration dates that exceed the product's true shelf life. 70 units are affected.

    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-1776-2026·2026-04-15

    Cook Medical micro wire guides labeled with overstated expiration dates

    Cook Medical is recalling Approach CTO-12 Micro Wire Guides because affected lots were labeled with expiration dates that exceed the product's true shelf life. 49 units are affected.

    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-1779-2026·2026-04-15

    Blue Rhino G2-Multi tracheostomy introducer sets carry overstated expiration dates

    Cook Medical is recalling Blue Rhino G2-Multi Percutaneous Tracheostomy Introducer Sets because affected lots were labeled with expiration dates that exceed the true shelf life. 916 units are affected.

    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-1784-2026·2026-04-15

    Cook Medical bile duct exploration sets labeled with overstated expiration dates

    Cook Medical is recalling the Strange Bile Duct Stone Exploration Set because affected lots were labeled with expiration dates that exceed the product's true shelf life. 49 units are affected.

    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-1775-2026·2026-04-15

    Cook Medical Micro Wire Guides Recalled Due to Incorrect Expiration Dates

    Cook Incorporated is recalling specific lots of COOK MEDICAL Approach CTO-6 Micro Wire Guides because they were labeled with expiration dates that exceed their actual shelf life.

    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
  • ModerateFDA (Devices)·Z-0994-2026·2025-12-31

    Transjugular access sets recalled over products manufactured out of specification

    Cook Incorporated is recalling 15 Ring Transjugular Intrahepatic Access Sets because affected lots may have been cut to the incorrect length, not correctly trimmed, and not properly 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
  • ModerateFDA (Devices)·Z-0995-2026·2025-12-31

    Transjugular liver access sets recalled over products manufactured out of specification

    Cook Incorporated is recalling 23 Rosch-Uchida Transjugular Liver Access Sets because affected lots may have been cut to the incorrect length, not correctly trimmed, and not properly 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
  • ModerateFDA (Devices)·Z-0993-2026·2025-12-31

    Check-Flo introducers recalled over products manufactured out of specification

    Cook Incorporated is recalling 7,952 Flexor Check-Flo Introducers and Sets because affected lots may have been cut to the incorrect length, not correctly trimmed, and not properly 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

    Cook Beacon Tip Angiographic Catheters Recalled for Tip Separation Risk

    Cook Incorporated is recalling specific lots of Beacon Tip 5.0 Fr Angiographic catheters due to the risk that the catheter tip may separate during use. The affected catheters were 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