The Recall Desk

Manufacturer

Cook Incorporated

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

What the numbers show

Total
86
Critical
2
Severe
4
Most recent
2026-10-21

Of the 86 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.

26–50 of 86

  • 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…
    Category
    Medical Device
    Distribution
    0 states
  • HighFDA (Devices)·Z-1787-2025·2025-05-28

    Check-Flo Performer Introducer Medical Device Recall Notice

    Cook Incorporated is recalling Check-Flo Performer Introducer devices because some units from affected lots may contain an incorrectly sized introducer sheath.

    Product
    Check=Flo Performer Introducer, 14.0Fr, Reference Part Number(RPN) REF RCFW-14.0-0-38-30-RB, Order Number (GPN) REF G08957,
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1786-2025·2025-05-28

    Check-Flo Performer Introducer medical device recall for incorrect sheath sizing

    Cook Incorporated is recalling Check-Flo Performer Introducer devices (10.0Fr) because affected units may contain an incorrectly sized introducer sheath, which could compromise proper device function.

    Product
    Check=Flo Performer Introducer, 10.0Fr, Reference Part Number(RPN) REF RCFW-10.0-0-38-30-RB, Order Number (GPN) REF G08686,
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1762-2025·2025-05-21

    Tornado Embolization Microcoil recalled for incorrectly sized coils

    Cook Incorporated is recalling Tornado Embolization Microcoils due to incorrectly sized coils in affected lots. The devices are used for vascular embolization procedures.

    Product
    Tornado Embolization Microcoil, intended for embolization of selective vessel supply to arteriovenous malformations and other vascular lesions, RPN MWCE-18S-3/2-TORNADO (GPN G08261), RPN MWCE-18S-3/2-TORNADO-081800 (GPN G13102), RPN MWCE-18S-4/2-TORNADO (GPN G08357)
    Category
    Medical Device
    Distribution
    0 states
  • HighFDA (Devices)·Z-0499-2025·2024-11-27

    Cook Incorporated Recalls Approach CTO Micro Wire Guide for Incorrect Expiration Dates

    Cook Incorporated is recalling Approach CTO Micro Wire Guide devices due to incorrect expiration dates printed on product labels. Contact the manufacturer for corrected expiration information.

    Product
    Approach CTO Micro Wire Guide, RPN CMW-14-190-25G, GPN G50789
    Category
    Medical Device
    Distribution
    0 states
  • HighFDA (Devices)·Z-0347-2025·2024-11-20

    Approach Hydro ST Micro Wire Guide Recalled for Incorrect Expiration Dates

    Cook Incorporated is recalling Approach Hydro ST Micro Wire Guide devices because affected device labels contain incorrect expiration dates. Using mislabeled devices beyond their actual expiration creates a risk of device failure and patient harm.

    Product
    Approach Hydro ST Micro Wire Guide; Catalog prefix HMW Reference Part Numbers: HMW-14-135-ST HMW-14-190-ST HMW-14-300-ST
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0346-2025·2024-11-20

    Cook Approach CTO Micro Wire Guide recalled for incorrect expiration date labels

    Cook Incorporated is recalling Approach CTO Micro Wire Guide devices due to incorrect expiration dates on affected lot labels. The recall affects 2,005 units in the US and 1,145 units overseas.

    Product
    Approach CTO Micro Wire Guide, Guide Wire, Catalog Prefix CMW; Reference Part Numbers: CMW-14-190-12G CMW-14-190-18G CMW-14-190-25G CMW-14-190-6G CMW-14-300-12G CMW-14-300-18G CMW-14-300-25G CMW-14-300-6G
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0045-2025·2024-10-16

    Check-Flo Performer Introducer Set white caps may disconnect

    Cook Incorporated is recalling Check-Flo Performer Introducer Sets due to white caps that may disconnect from the shaft-hub connection. Affected units were distributed to Australia.

    Product
    Check-Flo Performer Introducer Set, Reference Part Number RCF-5.0-35-45-J, Order Number G27242. Performer Introducers are designed to perform as a guiding sheath and/or introducer sheath and come with a Check Flo valve.
    Category
    Medical Device
    Distribution
    0 states
  • HighFDA (Devices)·Z-2222-2024·2024-07-03

    Drainage Catheter Recalled Due to Incorrect Expiration Dates on Labels

    Cook Incorporated is recalling 15 units of the Ultrathane Mac-Loc Locking Loop Multipurpose Drainage Catheter due to incorrect expiration dates on product labels that extend beyond the device's true expiration date. Affected units were distributed to Spain and the Netherlands.

    Product
    Ultrathane Mac-Loc Locking Loop Multipurpose Drainage Catheter ULT16.0-38-25-P-6S-MCL-HC--Intended for percutaneous drainage in a variety of drainage applications (e.g., nephrostomy, biliary and abscess), either by direct stick or Seldinger access technique. ORDER NUMBER: GPN…
    Category
    Medical Device
    Distribution
    1 state
  • ModerateFDA (Devices)·Z-2223-2024·2024-07-03

    Cook Drainage Catheter Recall: Incorrect Expiration Date Labels

    Cook Incorporated is recalling 15 units of a multipurpose drainage catheter due to product labels stating incorrect expiration dates that extend beyond the devices' true expiration, creating a risk of expired device use.

    Product
    Ultrathane Cook-Cope Type Locking Loop Multipurpose Drainage Catheter-ULT12.0-38-45-P-6S-CLM-RH-ntended for percutaneous drainage in a variety of drainage applications (e.g., nephrostomy, biliary and abscess), either by direct stick or Seldinger access technique ORDER NUMBER…
    Category
    Medical Device
    Distribution
    1 state
  • HighFDA (Devices)·Z-1530-2024·2024-04-24

    Cook Incorporated Dilators Recalled for Low Packaging Seal Strength

    Cook Incorporated is recalling 5,998 dilators worldwide because packaging may not meet seal strength specifications, potentially compromising device sterility.

    Product
    Dilator - Intended to be used for dilating puncture sites or catheter tracts for percutaneous placement of devices for vascular and non-vascular applications such as in the venous, arterial, biliary and renal systems. 1) JCD10.0-38-20 2) JCD20.0-38-20 3) JCD22.0-38-20 4)…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1532-2024·2024-04-24

    Cook Coons Taper Dilators recalled due to low packaging seal strength

    Cook Incorporated is recalling 4,856 Coons Taper Dilators because packaging may have low seal strength, compromising device sterility. These percutaneous dilators are used in vascular and non-vascular procedures and are distributed worldwide.

    Product
    Dilator - Coons Taper - Used for dilating puncture sites or catheter tracts for percutaneous placement of devices for vascular and non-vascular applications such as in the venous, arterial, biliary and renal systems. REFERENCE PART NUMBER (RPN)/ORDER NUMBER (GPN): 1)…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1525-2024·2024-04-24

    Chiba Biopsy Needles Recalled for Potential Sterility Compromise

    Cook Incorporated is recalling Chiba Biopsy Needles due to packaging that may have low seal strength, potentially compromising device sterility. The recall affects 6,178 units distributed worldwide.

    Product
    Chiba Biopsy Needle - Used for aspiration biopsy. REFERENCE PART NUMBER (RPN) ORDER NUMBER (GPN): 1) DCHN-18-10.0 G01559 2) DCHN-18-10.0-U G05040 3) DCHN-18-15.0 G00850 4) DCHN-22-10.0 G00852 5) DCHN-22-10.0-U G03978 6) DCHN-22-15.0 G00012 7) DCHN-22-15.0-U G03314…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1531-2024·2024-04-24

    Dilators With AQ Hydrophilic Coating recalled due to packaging seal defects

    Cook Incorporated is recalling 1,493 Dilators With AQ Hydrophilic Coating due to packaging that may not maintain proper seal strength, potentially compromising device sterility.

    Product
    Dilator With AQ Hydrophilic Coating - Intended to be used for dilating puncture sites or catheter tracts for percutaneous placement of devices for vascular and non-vascular applications such as in the venous, arterial, biliary and renal systems. REFERENCE PART NUMBER…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1529-2024·2024-04-24

    Gastrointestinal Suture Anchor Recalled Due to Packaging Seal Defect

    Cook Incorporated is recalling the Entuit Secure Adjustable Gastrointestinal Suture Anchor Set due to packaging that may have insufficient seal strength, potentially compromising device sterility. The recalled lot is distributed worldwide.

    Product
    Entuit Secure Adjustable Gastrointestinal Suture Anchor Set - Intended for anchoring the anterior wall of the stomach to the abdominal wall prior to introduction of interventional catheters. REFERENCE PART NUMBER (RPN): GIAS-SRM-ADJ-2 ORDER NUMBER (GPN): G35562
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1527-2024·2024-04-24

    Cook Centesis Catheter Needle recalled for packaging seal defect

    Cook Incorporated recalled the Yueh Centesis Disposable Catheter Needle due to packaging with low seal strength that may compromise device sterility. The recall affects 296 units distributed worldwide.

    Product
    Yueh Centesis Disposable Catheter Needle - Intended for use in percutaneous fluid aspirations, such as paracentesis or thoracentesis. REFERENCE PART NUMBER (RPN): DTVN-5.0-19-10.0- YUEH ORDER NUMBER (GPN): G09490
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1528-2024·2024-04-24

    Peel-Away Introducer medical devices recalled for low packaging seal strength

    Cook Incorporated is recalling 55 Peel-Away Introducers due to packaging with low seal strength that may compromise device sterility.

    Product
    Peel-Away Introducer - Intended for the percutaneous introduction of balloon, electrode and closed or non-tapered end catheters into central and peripheral vasculature, and for nonvascular use. REFERENCE PART NUMBER (RPN)/ ORDER NUMBER (GPN): 1)PLVW-7.0-35 G00925…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1526-2024·2024-04-24

    Trocar Needle Recall Due to Packaging Seal Strength Defect

    Cook Incorporated recalled 55 Trocar Needles (Lot 15786588) due to packaging that may not meet peel strength specifications, potentially compromising device sterility. Units were distributed nationwide and internationally.

    Product
    Trocar Needle - Used for dilating puncture sites or catheter tracts for percutaneous placement of devices for vascular and non-vascular applications such as in the venous, arterial, biliary and renal system REFERENCE PART NUMBER (RPN): DTN-18-20.0 ORDER NUMBER (GPN)…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-1427-2023·2023-05-17

    Blue Rhino G2 Tracheostomy Introducer Sets Recalled for Unsecure Connections

    Cook Incorporated is recalling Blue Rhino G2-Multi Percutaneous Tracheostomy Introducer Sets due to unsecure connections with 15mm caps and circuit components that may disconnect during medical procedures.

    Product
    Blue Rhino G2-Multi Percutaneous Tracheostomy Introducer Set, Reference Part Numbers C-PTIS-100-HC-G-EU-FLEX7.5 (G57695), C-PTIS-100-HC-G-EU-FLEX8.5 (G57696), C-PTIS-100-HC-G-NA-FLEX7.5 (G57691), C-PTIS-100-HC-G-NA-FLEX8.5 (G57692)
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-1428-2023·2023-05-17

    Cook Blue Rhino G2 Tracheostomy Introducer Trays Recalled for Connection Defect

    Cook Incorporated is recalling Blue Rhino G2-Multi Percutaneous Tracheostomy Introducer Trays because the device connectors are not making secure connections with 15mm caps and other circuit components, resulting in unsecure connections.

    Product
    Blue Rhino G2-Multi Percutaneous Tracheostomy Introducer Tray, Reference Part Numbers C-PTISYJ-100-HC-G-EU-FLEX8.5 (G57725), C-PTISYJ-100-HC-G-NA-FLEX7.5 (G57720), C-PTISYJ-100-HC-G-NA-FLEX8.5 (G57721), C-PTISY-100-HC-G-NA-FLEX8.5 (G57717), C-PTISY-100-HC-G-NA-FLEX7.5 (G57716)
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1830-2022·2022-10-05

    Cope Mandril Wire Guide Guidewires Recalled for Packaging Seal Breach

    Cook Incorporated is recalling Cope Mandril Wire Guide stainless steel guidewires because the packaging chevron seal may be completely breached, compromising device sterility. Affected lots total 2,748 units in the US and 302 internationally.

    Product
    Cope Mandril Wire Guide (Stainless Steel), Stainless Steel Guidewire Reference Part Number/GPN PMG-18SP-60-COPE G05183 PMG-18SP-100-COPE G05822 PMG-18SP-125-COPE G10077
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1839-2022·2022-10-05

    Cook Roadrunner Guidewire Recalled for Compromised Sterile Packaging Seal

    Cook Incorporated is recalling Roadrunner PC Wire Guide guidewires due to a complete breach of the sterile packaging seal. The breach may compromise device sterility, affecting 202 units in the US and 11 internationally.

    Product
    Roadrunner PC Wire Guide (Nimble Floppy), Guidewire RFPC-35-145 G07914
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1840-2022·2022-10-05

    Cook Roadrunner PC Guidewire Recalled for Compromised Packaging Seal

    Cook Incorporated recalls Roadrunner PC Wire Guide devices due to a potential packaging seal breach that may compromise sterility. The recall affects 115 units distributed domestically and internationally.

    Product
    Roadrunner PC Wire Guide (The Firm LT), Guidewire Reference Part Number/GPN RLPC-35-145 G06866
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1826-2022·2022-10-05

    Bentson Wire Guide Devices Recalled for Potential Sterility Compromise

    Cook Incorporated is recalling Bentson Wire Guide devices due to potential packaging defects that may compromise device sterility.

    Product
    Bentson Wire Guide, Guidewire (OUS ONLY); Reference Part Number: TSMB-35-145 (GPN G27041)
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1831-2022·2022-10-05

    Cook Medical Wire Guide Devices Recalled for Packaging Breach

    Cook Incorporated is recalling specific lots of Double Flexible Tipped Wire Guide Guidewire devices due to a complete breach of the packaging chevron seal, which may compromise sterility.

    Product
    Double Flexible Tipped Wire Guide, Guidewire Reference Part Number/GPN TDOC-35-145-0-3 G00362 C-TDOC-18-50-0-2 G05146 TDOC-35-50-0-3 G00364 C-DOC-21-40-0-2 G02431 C-TDOC-21-50-0-2 G05195 C-TDOC-25-50-0-2 G05145
    Category
    Medical Device
    Distribution
    Distributed nationwide