The Recall Desk

Manufacturer

Cook, Inc.

264 recalls in our database name Cook, Inc. as the manufacturing or recalling firm.

What the numbers show

Total
264
Critical
5
Severe
51
Most recent
2021-12-29

Of the 264 recalls from Cook, Inc. we have scored against our rubric, 5 (2%) are Critical — deaths or serious injuries reported, or the agency’s own highest classification — and 51 (19%) 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.

151–175 of 264

  • ModerateFDA (Devices)·Z-1369-2019·2019-05-29

    Cook Kwart Retro-Inject Ureteral Stent Set Recalled for Missing Warning

    Cook Inc. is recalling Kwart Retro-Inject Ureteral Stent Sets because the instructions for use did not include a warning for stent knotting.

    Product
    Cook Kwart Retro-Inject Ureteral Stent Set: PRODUCT/CATALOG NUMBER/GPN: 4.7 Fr 003500 G14916; 6.0 Fr 003600 G14836; 7.0 Fr 003700 G14837; 8.0 Fr 003800 G14844; Set with AQ¿ Hydrophilic Coating PRODUCT/CATALOG NUMBER/GPN: 4.7 Fr AQ-003500 G17150; 6.0 Fr
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0979-2019·2019-03-20

    Cook Transseptal Needle Recalled for Missing Back Bevel

    Cook Inc. is recalling 100 units of Transseptal Needles manufactured without a back bevel on the needle tip, which could damage the introducer during insertion.

    Product
    Cook Transseptal Needle, Reference Number TSNC-18-71.0, Order Number G02364. For transseptal left heart access in both diagnostic and interventional procedures.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0967-2019·2019-03-06

    Cook Inc. Recalls Gastrointestinal Suture Anchor Sets Due to Retention Mechanism Issue

    Cook Inc. is recalling 797 Entuit Secure Gastrointestinal Suture Anchor Sets because a specific extension spring lot may cause difficulty sliding the retention mechanism.

    Product
    Entuit Secure Gastrointestinal Suture Anchor Set, Catalog Number GIAS-SRM-2, Order Number G35569 The Entuit Secure Gastrointestinal Suture Anchor Set is intended for anchoring the anterior wall of the stomach to the abdominal wall prior to the introduction of interventional ca
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0968-2019·2019-03-06

    Cook Inc. Recalls Gastrointestinal Suture Anchor Sets Due to Retention Mechanism Issue

    Cook Inc. is recalling 975 Entuit Secure Gastrointestinal Suture Anchor Sets because a specific extension spring lot may cause difficulty sliding down the retention mechanism.

    Product
    Entuit Secure Gastrointestinal Suture Anchor Set, Catalog Number GIAS-SRM-3, Order Number G35570 The Entuit Secure Gastrointestinal Suture Anchor Set is intended for anchoring the anterior wall of the stomach to the abdominal wall prior to the introduction of interventional ca
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-2791-2018·2018-08-22

    Cook Inc. Recalls VentriClear Ventricular Drainage Catheter Sets Due to Endotoxin Failure

    Cook Inc. is recalling 250 units of the VentriClear Ventricular Drainage Catheter Set because the product failed endotoxin testing. The recall involves one distributor in Indiana, and the product was not distributed to end users.

    Product
    VentriClear Ventricular Drainage Catheter Set, Cat. No. N-VVDC-01-ABRM Product Usage: The VentriClear Ventricular Drainage Catheter Set has been designed for obtaining access to a ventricular cavity of the brain for short-term use to externally drain fluid for the purpose of
    Category
    Medical Device
    Distribution
    1 state
  • HighFDA (Devices)·Z-1754-2018·2018-05-16

    Cook Inc. Recalls Connecting Tubes Due to Potential Leakage

    Cook Inc. is recalling 304 connecting tubes because the cap-adapter assembly may not tighten adequately, potentially causing fluid leakage or air aspiration.

    Product
    Connecting Tube - Female to Male Luer Lock, HPCT8.8-80-M-FM Product Usage: The connecting tube is intended to be a conduit between a fluid reservoir and a vascular catheter in the patient. The connecting tube may be used during angiographic procedures to connect radiographic
    Category
    Medical Device
    Distribution
    7 states
  • HighFDA (Devices)·Z-1751-2018·2018-05-16

    Cook Inc. Recalls Connecting Tubes Due to Potential Leakage

    Cook Inc. is recalling 220 connecting tubes because the cap-adapter assembly may not be adequately tightened, potentially leading to fluid leakage or air aspiration.

    Product
    Connecting Tube - Female to Male Luer Lock, HPCT8.8-60-M-FM Product Usage: The connecting tube is intended to be a conduit between a fluid reservoir and a vascular catheter in the patient. The connecting tube may be used during angiographic procedures to connect radiographic
    Category
    Medical Device
    Distribution
    7 states
  • HighFDA (Devices)·Z-1753-2018·2018-05-16

    Cook Inc. Recalls Connecting Tubes Due to Potential Leakage or Air Aspiration

    Cook Inc. is recalling 886 connecting tubes because the cap-adapter assembly may not be adequately tightened, potentially leading to fluid leakage or air aspiration.

    Product
    Connecting Tube - Female to Male Luer Lock, HPCT8.8-30-M-FM Product Usage: The connecting tube is intended to be a conduit between a fluid reservoir and a vascular catheter in the patient. The connecting tube may be used during angiographic procedures to connect radiographic
    Category
    Medical Device
    Distribution
    7 states
  • HighFDA (Devices)·Z-1755-2018·2018-05-16

    Cook Inc. Recalls Connecting Tubes Due to Potential Leakage or Air Aspiration

    Cook Inc. is recalling 554 connecting tubes because the cap-adapter assembly may not be adequately tightened, potentially leading to fluid leakage or air aspiration.

    Product
    Connecting Tube - Female to Male Luer Lock, HPCT8.8-100-M-FM Product Usage: The connecting tube is intended to be a conduit between a fluid reservoir and a vascular catheter in the patient. The connecting tube may be used during angiographic procedures to connect radiographic
    Category
    Medical Device
    Distribution
    7 states
  • HighFDA (Devices)·Z-1756-2018·2018-05-16

    Cook Inc. Recalls Connecting Tubes Due to Potential Leakage or Air Aspiration

    Cook Inc. is recalling 6,345 connecting tubes because the cap-adapter assembly may not be adequately tightened, potentially leading to fluid leakage or air aspiration.

    Product
    Connecting Tube - Female to Male Luer Lock, HPCT8.8-120-M-FM Product Usage: The connecting tube is intended to be a conduit between a fluid reservoir and a vascular catheter in the patient. The connecting tube may be used during angiographic procedures to connect radiographic
    Category
    Medical Device
    Distribution
    7 states
  • HighFDA (Devices)·Z-1752-2018·2018-05-16

    Cook Inc. Recalls Connecting Tubes Due to Potential Fluid Leakage

    Cook Inc. is recalling 220 connecting tubes because the cap-adapter assembly may not be adequately tightened, potentially leading to fluid leakage or air aspiration.

    Product
    Connecting Tube - Female to Male Luer Lock, HPCT8.8-60-M-FM-BNS Product Usage: The connecting tube is intended to be a conduit between a fluid reservoir and a vascular catheter in the patient. The connecting tube may be used during angiographic procedures to connect radiograp
    Category
    Medical Device
    Distribution
    7 states
  • HighFDA (Devices)·Z-1596-2018·2018-05-09

    Cook Inc. Recalls StoneBreaker Single Use Probes for Sterility Concerns

    Cook Inc. is recalling 12,556 StoneBreaker Single Use Probes because the interior may not be properly sterilized. The recall covers units distributed in the US and 70 other countries.

    Product
    StoneBreaker Single Use Probe, Catalog numbers: SBP-010500; SBP-010605; SBP-016500; SBP-016605; SBP-020425 GPN : G52607; G52605; G52606; G52609; G52608
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1592-2018·2018-05-09

    Cook Inc. Recalls StoneBreaker Exhaust Lines Due to Sterility Concerns

    Cook Inc. is recalling 760 StoneBreaker Exhaust Lines because the interior may not be properly sterilized during reprocessing.

    Product
    StoneBreaker Exhaust Line, Catalog number: SBA-EL; GPN: G52600; UDI: (01)00827002526006
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1590-2018·2018-05-09

    Cook Inc. Recalls StoneBreaker Pneumatic Lithotripter Due to Sterility Concerns

    Cook Inc. is recalling 751 units of the StoneBreaker Pneumatic Lithotripter because the device may not be properly sterilized during reprocessing.

    Product
    StoneBreaker Pneumatic Lithotripter, Catalog number: SBL-KIT1; GPN: G52604 UDI:(01)00827002526044
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1594-2018·2018-05-09

    Cook Inc. Recalls StoneBreaker Sterilization Caps Due to Sterility Concerns

    Cook Inc. is recalling 470 StoneBreaker Sterilization Caps because the interior may not reach the required Sterility Assurance Level during reprocessing.

    Product
    StoneBreaker Sterilization Cap, Catalog number: SBA-SC; GPN: G52602; UDI: (01)00827002526020
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1591-2018·2018-05-09

    Cook Inc. Recalls StoneBreaker Exhaust Caps Due to Sterility Concerns

    Cook Inc. is recalling 629 StoneBreaker Exhaust Caps because the interior may not be sterilized to the appropriate level when following reprocessing instructions.

    Product
    StoneBreaker Exhaust Cap, Catalog number: SBA-EC; GPN: G52599; UDI: (01)00827002525993
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1593-2018·2018-05-09

    Cook Inc. Recalls StoneBreaker Probe Caps Due to Sterility Concerns

    Cook Inc. is recalling 370 StoneBreaker Probe Caps because the interior may not be properly sterilized during reprocessing.

    Product
    StoneBreaker Probe Cap, Catalog number:SBA-PC; GPN: G52601; UDI:(01)00827002526013
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1595-2018·2018-05-09

    Cook Inc. Recalls StoneBreaker C02 Cartridges Due to Sterility Concerns

    Cook Inc. is recalling 38,542 StoneBreaker C02 Cartridges because the interior may not be sterilized to the appropriate level when reprocessed.

    Product
    StoneBreaker C02 Cartridge, Catalog number: SBC-10; GPN: G52603; UDI: (01)10827002526034
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1521-2018·2018-05-02

    Cook Inc. Recalls Advance 35LP Balloon Catheters Due to Labeling Error

    Cook Inc. is recalling 40 Advance 35LP Low-Profile PTA Balloon Dilatation Catheters because some units were packaged with incorrect size labels.

    Product
    Advance¿ 35LP Low-Profile PTA Balloon Dilatation Catheter; Catalog numbers: PTA5-35-135-6-2 .0 and PTA5-35-135-4-4 .0; UDI: 10827002522647 and 10827002522524 Product Usage: The Advance¿ 35LP Low Profile PTA Balloon Dilation Catheter is indicated for percutaneous translumin
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-1460-2018·2018-04-25

    Cook Vacuum Pump Recalled for Electrical Shock and Burn Risk

    Cook Inc. is recalling 132 Cook Vacuum Pumps (K-MAR-5200-US) worldwide due to defective crimp connectors that may cause device failure, electric shock, or burns.

    Product
    Cook Vacuum Pump (Cook Aspiration Unit) K-MAR-5200-US, GPN G51607. Intended for the aspiration of body fluids and cells; in particular oocyte aspiration.
    Category
    Medical Device
    Distribution
    0 states
  • SevereFDA (Devices)·Z-1461-2018·2018-04-25

    Cook Vacuum Pump Recalled for Electrical Shock and Burn Risk

    Cook Inc. is recalling 2,267 Cook Vacuum Pumps (K-MAR-5200-US) worldwide due to defective crimp connectors that may cause device failure, electric shock, or burns.

    Product
    Cook Vacuum Pump ( Cook Aspiration Unit) K-MAR-5200-US, GPN G49275. Intended for the aspiration of body fluids and cells, in particular oocyte aspiration.
    Category
    Medical Device
    Distribution
    0 states
  • HighFDA (Devices)·Z-1378-2018·2018-04-25

    Cook Inc. Recalls MINC Benchtop Incubators Due to Temperature Control Defect

    Cook Inc. is recalling 4,451 MINC Benchtop Incubators because a heater defect may cause temperatures to become too high or too low for proper cell culture.

    Product
    MINC Benchtop Incubator (Mini Incubator) catalog (K-MINC-1000) G20079 is a microprocessor controlled, gassed, humidified, incubator intended for use in cell culture.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1377-2018·2018-04-25

    Cook Inc. Recalls MINC Benchtop Incubators Due to Temperature Control Defect

    Cook Inc. is recalling 483 MINC Benchtop Incubators because a heater failure may cause temperatures to become too high or too low for proper cell culture.

    Product
    MINC Benchtop Incubator (Mini Incubator) catalog (K-MINC-1000 US) G46022 is a microprocessor controlled, gassed, humidified, incubator intended for use in cell culture.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1185-2018·2018-04-04

    Cook Inc. Recalls IVF Embryo Transfer Syringes Due to Quality Testing Gaps

    Cook Inc. is recalling specific lots of Norm-Ject Tuberkulin Syringes used for IVF embryo transfer because they were distributed without completed quality testing.

    Product
    Norm-Ject Tuberkulin Syringe, Catalog Number: K-ATS-1000, Global Product Number: G19871 Product Usage: Used to place in vitro fertilized (IVF) embryos into the uterine cavity. Intended for one-time use
    Category
    Medical Device
    Distribution
    Distributed nationwide