Facility

Cook Incorporated

77 recall(s) on record — most severe on record: Class I.

Key facts

77recalls · worst Class I

1inspections · worst VAI

—warning letters in our data

Recalls are listed for the parent company: openFDA recall records do not name a facility. How we attribute records

FDA Establishment Identifier (FEI)	3011050534
Establishment type	Manufacture Medical Device
Location	300 E Elm St Canton, IL, US 61520
Registration status	Active · expires 2026
Parent company	COOK, INC. (owner-operator 1820334)
Brand names	Aintree Intubation Catheter with Rapi-Fit Adapter; Cook Airway Exchange Catheter with Rapi-Fit Adapters; Arndt Airway Exchange Catheter Set with Rapi-Fit Adapters

Activity by year

Recalls (77)
Inspections (1)

Devices registered here (2)

Stylet, Tracheal Tube
Product code BSR (opens in a new tab) · Class I · Anesthesiology · 21 CFR 868.5790
Tube, Tracheal (W/Wo Connector)
Product code BTR (opens in a new tab) · Class II · Anesthesiology · 21 CFR 868.5730

Recalls & enforcement

20262 records

Class IOngoing2026-04-02
Marker bands may be at an increased risk of cracking/breakage. Potential adverse events that may result include increased procedural time, harms associated with device fragmentation/separation, and vessel injury. In a worst-case scenario, device fragmentation and separation may c…
Class IIOngoing2026-03-05
Products from the affected device lots were labeled with expiration dates that exceed the true shelf life.

20254 records

Class IIOngoing2025-11-26
Cook Medical identified that products supplied in the affected device lots may have been manufactured out of specification. Impacted products may have been cut to the incorrect length, not correctly trimmed, and not inspected properly.
Class IOngoing2025-05-15
Cook Medical identified that catheters supplied in the affected device lots may experience tip separation.
Class IIOngoing2025-04-17
Cook Medical identified that devices from the affected device lots may contain the incorrectly sized introducer sheath.
Class IIOngoing2025-04-17
Cook Medical identified that devices from the affected device lots may contain the incorrectly sized embolization coil.

20245 records

Class IIOngoing2024-10-14
Devices from the affected device lots have labels that state the incorrect expiration dates.
Class IIOngoing2024-10-08
Affected device lots have labels that state the incorrect expiration dates.
Class IIOngoing2024-09-16
Cook Medical is conducting removal of a lot of Check-Flo Performer Introducer Set due to complaints that the white caps that connect the shaft to the hub of these products may disconnect.
Class IIOngoing2024-05-15
Product labels state the incorrect expiration dates that extends beyond their true expiration date
Class IIOngoing2024-03-01
Packaging may have low seal strength and not meet peel strength specifications, compromising device sterility

20231 record

Class IOngoing2023-04-07
There were reports from customers that the tracheostomy in the sets and trays is not making a secure connection with the 15mm cap and other 15mm circuit components and accessories. This resulted in an unsecure connection between the device connector and circuit components, cap, …

20224 records

Class IIOngoing2022-08-16
Cook Medical identified that devices from the affected device lots may have a complete breach of the chevron seal of the packaging. Therefore, the sterility of affected devices may be compromised.
Class IIOngoing2022-07-19
Product did not meet the acceptance criteria for packaging testing, which included 3-year age acceleration testing, therefore, the sterility of the device may be compromised.
Class IICompleted2022-05-25
The products may contain excess coating material on the outside and/or interior of the needle component. Potential adverse events that may occur if an affected product is used include a delay in the procedure, a prolonged procedure, or particulate entering the bloodstream which …
Class IIOngoing2022-05-05
The loading cartridges included with these devices may contain a small, unintended, stainless-steel cannula.

20215 records

Class IITerminated2021-11-12
Flexor Check-Flo Introducer Ansel Modification mislabeled. Products packaged with a label stating 6FR may contain a 7FR device and vice versa
Class IIOngoing2021-10-13
Specific lots may contain black debris on the exterior of the inner stylet and/or on the interior of the outer cannula. Local inflammatory reactions may occur if an affected product is used.
Class IITerminated2021-10-08
Transseptal needles may contain rust on the interior and/or exterior of the needle, which may not be detected by the user. Potential adverse events if an affected product is used ranges from increased procedural time to inflammatory reactions, which at their most severe include s…
Class IITerminated2021-09-28
Affected lots may be manufactured incorrectly with the radiopaque marker band located just below the Check-Flo proximal fitting instead of the distal tip. The issue may not be identified until the device is placed in the patient and viewed under fluoroscopy, leading to increased …
Class IITerminated2021-01-04
Manufactured with incorrect material, which may result in the stent being stiffer and potentially susceptible to degradation could potentially lead to breakage/fragmentation.

202010 records

Class ITerminated2020-11-24
There is an increased likelihood of the introducer sheath separating at the proximal bond site. If separation occurs during use, it could result in life-threatening adverse events. The potential adverse events that may occur include, but are not limited to increased procedural t…
Class ITerminated2020-10-22
Affected product was dropped during manufacturing, which may result in a bent wire guide and/or the presence of loose foreign matter on the wire guide.
Class IITerminated2020-08-31
The indwell time for the Percutaneous Neonatal Pigtail Nephrostomy Set and Pediatric Nephrostomy Stent Set is decreasing from 4 months to 4 weeks. The current IFU is in process of being updated and will be provided with orders placed following implementation.
Class IITerminated2020-08-11
May contain excess glue within the handle of the delivery system, resulting in an inability to fully deploy the graft via the standard method or troubleshooting deployment method provided in the IFU
Class IITerminated2020-07-30
Universa Soft Ureteral Stent Sets were incorrectly placed in the outer boxes labeled as Universa Firm Ureteral Stent Set ;pouch label reflects the packaged product.
Class IITerminated2020-06-02
Identified products may contain a damaged bushing within the delivery system, which could potentially result in difficulty or an inability to fully deploy the graft via the standard method provided in the IFU.
Class IITerminated2020-04-30
The Pressure Monitoring Set and Tray may contain excess coating material on the outside and/or interior of the needle component which could cause occlusion.
Class IITerminated2020-04-15
The firm received complaints on five devices from one specific lot where the stent dislodged from the balloon delivery system prior to deployment. Use of affected product may lead to increased procedural time and additional intervention to remove a stent that dislodged within an …
Class IITerminated2020-03-06
The printed expiration dates are incorrect.
Class IITerminated2020-01-16
The firm has identified factors which contributed to failures relating to thrombus formation and/or lumen occlusion reports, and is highlighting to customers key points of the IFU pertaining to the prevention of these factors. In addition, the firm has updated the Planning and Si…

201912 records

Class IITerminated2019-12-27
Specific lots of the Dawson-Mueller Drainage Catheter were not manufactured to specification, which could lead to leakage from the Mac-Loc hub assembly.
Class ITerminated2019-11-08
A manufacturing error may cause the radiopaque marker bands to be too loose on certain CXC3.0 CrossCath Support Catheters (compatible with 0.014 wire guides) and too tight on certain CXC3.4 CrossCath Support Catheters (compatible with 0.018 wire guides).
Class IITerminated2019-10-21
The potential compromise of the sterility of products from an undersealed chevron in the packaging pouches of Torcon NB Advantage Catheters.
Class IITerminated2019-10-03
Bent transfer catheter tips may cause difficulty or inability in inserting the transfer catheter into the guiding catheter. Potential adverse events that may occur if an affected product is used include increased procedural time, the need for a repeat embryo transfer procedure, …
Class IITerminated2019-09-17
Lidstock perforation line may be over the sterile area of the tray, when it should be on the lip of the tray, potentially compromising the sterility of the device.
Class ITerminated2019-05-24
Multiple complaints were received for balloons bursting below the rated burst pressure. Potential adverse events that may occur if an affected product is used include a delay in the procedure, additional intervention, vessel injury, and balloon fragmentation in the patient.
Class IITerminated2019-05-02
The products may have been manufactured without the bottom seal on the outer packaging, compromising the sterility of the product.
Class IITerminated2019-04-26
may contain a damaged gray safety lock knob, which could potentially result in difficulty or an inability to fully deploy the graft via the standard or troubleshooting method provided in the Instructions for Use (IFU). Potential adverse events that may occur if an affected produ…
Class IITerminated2019-04-22
Kwart RetroInject Stent Set (Multi-Length) and Salle Intraoperative Pyeloplasty Stent Set Instructions for Use (IFU) did not include a warning for stent knotting.
Class IITerminated2019-04-09
Affected products may have been manufactured with the catheter distal end hole too small
Class ITerminated2019-02-01
The products were manufactured without a back bevel on the needle tip. This could cause damage to the inside of the introducer during needle insertion.
Class IITerminated2019-01-04
The wire guide may be incorrectly loaded into the wire guide holder, leading to the stiff tip of the wire guide being introduced into the patient instead of the flexible tip.

20188 records

Class IITerminated2018-12-21
The products were manufactured with longer than specified sheaths.
Class IITerminated2018-12-19
There is a potential for difficulty in sliding down the retention mechanism on the sets manufactured with a specific extension spring lot.
Class IITerminated2018-05-31
This lot of VentriClear failed endotoxin testing. Potential adverse events include immune responses ranging from non-specific febrile reaction to life-threatening systemic inflammatory response syndrome (SIRS).
Class IITerminated2018-04-16
Incorrect product labeling. Product labeled as 6mm x 2cm balloon are packaged with a 4mm x 4 cm balloon label and vice-versa.
Class IITerminated2018-03-29
Cap-adapter assembly of the device may potentially not be adequately tightened, possibly leading to fluid leakage from or air aspiration into the connecting tube.
Class IITerminated2018-03-22
Pump was found to be constructed from crimp connectors that do not meet the fixation wiring requirements and can cause failure of the device to operate or electric shock or burn to the user.
Class IITerminated2018-01-31
The interior of the product may not be sterilized to the appropriate Sterility Assurance Level when following the reprocessing instructions in the Instructions for Use.
Class IITerminated2018-01-12
The temperature of the incubation lids of the MINC Bench top Incubators may become too high or too low for proper gamete/embryo incubation due to fatigue failure of the flat flex lid heater.

201711 records

Class IITerminated2017-12-19
Certain lots of in vitro fertilization (IVF) products were distributed without completed finished device quality testing with potential adverse events that may include nonviable gametes and/or nonviable embryos.
Class IITerminated2017-10-19
Cook has identified that the affected lots may contain wire guides that were loaded backwards into the wire guide holder.
Class IITerminated2017-10-13
Label does not state that the product is heparin-coated.
Class IITerminated2017-07-31
Central venous catheters may not fit over guide wire potentially causing procedure delay.
Class IITerminated2017-05-09
Correction to the product Instructions for Use because the current reprocessing instructions do not provide sufficient detailed information for the cleaning, disinfection, and sterilization of these products.
Class IITerminated2017-05-03
Cook Inc. is initiating a voluntary recall of the OptiLite Multi-Use Holmium Laser Fibers because it has been identified that the reprocessing instructions do not provide sufficiently detailed information for the cleaning, disinfection, and sterilization of these products.
Class IITerminated2017-05-03
Cook Inc. is initiating a voluntary recall of the Vue Optic Visualization Source and the Flexor Vue Deflecting Endoscopic System because it was determined that the current reprocessing instructions do not provide sufficient detailed information for the cleaning, disinfection, and…
Class IITerminated2017-05-01
COOK Medical is initiating a voluntary recall of multiple products because the reprocessing instructions do not provide sufficient detailed information for the cleaning, disinfection, and sterilization of these products.
Class IITerminated2017-04-25
reprocessing instructions do not provide sufficient detailed information for the cleaning, disinfection, and sterilization of these products
Class IITerminated2017-03-07
Product may overheat, melt, and burn patient.
Class IITerminated2017-02-01
Devices using a specific hemostatic valve design, referred to as a blue valve or polyisoprene valve, have an increase in reports of blood loss associated with the devices which could result in delay in procedure and blood loss from patients.

20167 records

Class IITerminated2016-11-28
Cook Medical has received reports of the trays containing the incorrect needle, which in some cases could result in the inability to pass a wire guide through the needle. Potential adverse events that may occur as a result of utilizing needles of incorrect size include delay in …
Class ITerminated2016-06-24
Potential coating contamination with glass particles.
Class IITerminated2016-04-15
Increase in reports of polymer degradation of the catheter tip, resulting in tip fracture and/or separation. degradation could include loss of device function, separation of a device segment leading to medical intervention, or complications resulting from a separated segment. Su…
Class IITerminated2016-01-27
Cook Medical is voluntarily recalling specific lots of the Ultraxx" Nephrostomy Balloon Set and the Ascend® AQ® Ureteral Dilation Balloon Catheter Set because of a labeling mix-up. Cook Medical has received reports of packages labeled as Ultraxx" Nephrostomy Balloon Set actually…
Class IITerminated2016-01-20
Incorrect packaging. Reports of packages labeled as 6.0Fr actually containing 5.0Fr devices.
Class IITerminated2016-01-08
Product potentially exposed to body fluids during processing. Potential adverse events that may occur as a result of the foreign matter include blood borne pathogen transmission. However, the risk of transmission of blood borne pathogens is thought to be minimal to non-existent …
Class ITerminated2016-01-06
A manufacturing process may lead to catheter tip fracture and or separation. Potential adverse events may include loss of device function, medical intervention to retrieve a separated segment, or complications resulting from a separated tip occluding blood flow to end organs. Th…

20156 records

Class IITerminated2015-11-19
Cook Medical initiated a voluntary recall of specific lot numbers of the VentriClear II Ventricular Drainage Catheter Set due to the device being sterilized twice, which may result in the minocycline and rifampin catheter coating to be less than what is indicated on the labeling.
Class IITerminated2015-10-21
Cook Medical has received six product complaints associated with reports of the 2.6FR curved catheter being mixed with the 4.0FR straight catheter and vice versa. Investigation revealed the products were mixed during processing.
Class ITerminated2015-10-07
Reports of catheter tip splits and or separation. Loss of device function, medical intervention to retrieve separated segment, or complications resulting from separated tip occluding blood flow to end organs may result. Recall expanded 10/07/2015 to include additional catheters.
Class ITerminated2015-07-02
Reports of catheter tip splits and or separation. Loss of device function, medical intervention to retrieve separated segment, or complications resulting from separated tip occluding blood flow to end organs may result.
Class IITerminated2015-05-28
Cook Inc. is initiating a voluntary recall of the Ring Transjugular Intrahepatic Access Set and the Flexor RTPS Introduce Sheath due to complaints of the dilators being too long.
Class IITerminated2015-05-14
Includes Information not stated in the intended use.

20141 record

Class ITerminated2014-07-17
This remedial action is the result of six product complaints associated with separation of the snare from the distal tip of the wire.

20131 record

Class ITerminated2013-04-18
Cook Medical has received a small number of complaints related to the delivery system for the Zilver PTX Drug-Eluting Peripheral Stent involving fractures of the delivery system inner catheter after stent deployment, and separation of the inner catheter tip section (13 complain…

FDA inspections (1)

VAI2016-06-17
Voluntary Action Indicated · Compliance: Devices; Postmarket Assurance: Devices · citations posted

Source: U.S. FDA Inspections Dashboard (opens in a new tab) (device inspection classifications, 2016–present). Data as of 2026-10-06. The dashboard profile can take several seconds to load.

Source: U.S. FDA via openFDA (opens in a new tab) (device registration & enforcement). Data as of 2026-10-06. Verify this facility record at FDA → (opens in a new tab)

Cite this record

RegWarden. “Cook Incorporated (FEI 3011050534) — FDA facility record.” Compiled from U.S. FDA public records (openFDA; FDA Data Dashboard). Data as of 2026-10-06. https://regwarden.com/facility/3011050534-cook-incorporated/

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