Cook Inc. recalls
78 recalls in our records from 2013 to 2026: 78 FDA medical devices.
Recalls with full detail pages
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Cook Incorporated medical device recall: Centimeter Sizing Catheter RPN N5.0-35-100-P-10S-PIG-CSC-20 GPN…
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…
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Cook Incorporated medical device recall: Beacon Tip 5.0 Fr Angiographic catheters are designed to facilitate…
Cook Medical identified that catheters supplied in the affected device lots may experience tip separation.
Earlier and other recalls
These link to the official agency notice.
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Cook Incorporated medical device recall: Williams Cystoscopic Injection Needles Official notice ↗
The female Luer lock adapter component in the affected device lots may not have been correctly seated due to misalignment and inadequate torquing during manufacturing.…
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Cook Incorporated medical device recall: COOK MEDICAL Approach CTO-6 Micro Wire Guide Official notice ↗
Products from the affected device lots were labeled with expiration dates that exceed the true shelf life.
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Cook Incorporated medical device recall: Flexor Check-Flo Introducers and Sets Official notice ↗
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…
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Cook Incorporated medical device recall: Check=Flo Performer Introducer Official notice ↗
Cook Medical identified that devices from the affected device lots may contain the incorrectly sized introducer sheath.
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Cook Incorporated medical device recall: Tornado Embolization Microcoil Official notice ↗
Cook Medical identified that devices from the affected device lots may contain the incorrectly sized embolization coil.
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Cook Incorporated medical device recall: Approach CTO Micro Wire Guide Official notice ↗
Devices from the affected device lots have labels that state the incorrect expiration dates.
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Cook Incorporated medical device recall: Approach CTO Micro Wire Guide Official notice ↗
Affected device lots have labels that state the incorrect expiration dates.
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Cook Incorporated medical device recall: Check-Flo Performer Introducer Set Official notice ↗
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…
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Cook Incorporated medical device recall: Ultrathane Mac-Loc Locking Loop Multipurpose Drainage Catheter… Official notice ↗
Product labels state the incorrect expiration dates that extends beyond their true expiration date
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Cook Incorporated medical device recall: Chiba Biopsy Needle - Used for aspiration biopsy. REFERENCE PART… Official notice ↗
Packaging may have low seal strength and not meet peel strength specifications, compromising device sterility
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Cook Incorporated medical device recall: Blue Rhino G2-Multi Percutaneous Tracheostomy Introducer Set Official notice ↗
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…
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Cook Incorporated medical device recall: Amplatz extra Stiff Wire Guide Official notice ↗
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…
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Cook Incorporated medical device recall: Roadrunner PC Hydrophilic Wire Guide REFERENCE PART NUMBER Official notice ↗
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…
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Cook Incorporated medical device recall: Pressure Monitoring Set Official notice ↗
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…
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Cook Incorporated medical device recall: Hilal Embolization Microcoil Official notice ↗
The loading cartridges included with these devices may contain a small, unintended, stainless-steel cannula.
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Cook Inc. medical device recall: Skinny Needle with Chiba Tip. RPN 090010 Official notice ↗
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…
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Cook Inc. medical device recall: Flexor Check-Flo Introducer Ansel Modification Model Number:… Official notice ↗
Flexor Check-Flo Introducer Ansel Modification mislabeled. Products packaged with a label stating 6FR may contain a 7FR device and vice versa
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Cook Inc. medical device recall: Transseptal Needle Official notice ↗
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…
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Cook Inc. medical device recall: Flexor Check-Flo Introducer Official notice ↗
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…
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Cook Inc. medical device recall: Cook Medical Kwart Retro-Inject Ureteral Stent Set 7.0Fr. 22-32cm… Official notice ↗
Manufactured with incorrect material, which may result in the stent being stiffer and potentially susceptible to degradation could potentially lead to…
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Cook Inc. medical device recall: Flexor Check-Flo Introducer Official notice ↗
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…
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Cook Inc. medical device recall: Fixed Core Wire Guide Official notice ↗
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.
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Cook Inc. medical device recall: Percutaneous Neonatal Pigtail Nephrostomy Set Official notice ↗
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…
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Cook Inc. medical device recall: Cook Medical Universa Soft Ureteral Stent Sets-5 FR 26 cm Reference… Official notice ↗
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.
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Cook Inc. medical device recall: Zenith Alpha Abdominal Endovascular Graft - Distributed OUS only.… Official notice ↗
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…
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Cook Inc. medical device recall: Zenith Alpha Abdominal Endovascular Graft Official notice ↗
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…
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Cook Inc. medical device recall: Pressure Monitoring Set Official notice ↗
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.
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Cook Inc. medical device recall: Formula 418 Renal Balloon-Expandable Stent Official notice ↗
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…
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Cook Inc. medical device recall: Pericardiocentesis Set Official notice ↗
The printed expiration dates are incorrect.
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Cook Inc. medical device recall: Zenith Alpha Spiral-Z Endovascular Leg Official notice ↗
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…
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Cook Inc. medical device recall: Bentson PTFE Wire Guide Official notice ↗
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…
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Cook Inc. medical device recall: Dawson-Mueller Drainage Catheter Official notice ↗
Specific lots of the Dawson-Mueller Drainage Catheter were not manufactured to specification, which could lead to leakage from the Mac-Loc hub assembly.
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Cook Inc. medical device recall: CrossCath Support Catheter Official notice ↗
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…
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Cook Inc. medical device recall: Torcon NB Advantage Catheters - Product Usage: Intended for use in… Official notice ↗
The potential compromise of the sterility of products from an undersealed chevron in the packaging pouches of Torcon NB Advantage Catheters.
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Cook Inc. medical device recall: Guardia Access Nano Embryo Transfer Catheter is use for transferring… Official notice ↗
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…
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Cook Inc. medical device recall: Pneumothorax Tray Official notice ↗
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.
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Cook Inc. medical device recall: Zenith Alpha Abdominal Endovascular Graft Official notice ↗
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…
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Cook Inc. medical device recall: Advance Enforcer 35 Focal Force PTA Balloon Catheter 6mm x 4cm Official notice ↗
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…
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Cook Inc. medical device recall: Neff Percutaneous Access Set Official notice ↗
The products may have been manufactured without the bottom seal on the outer packaging, compromising the sterility of the product.
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Cook Inc. medical device recall: Pericardiocentesis Catheter Set Official notice ↗
Affected products may have been manufactured with the catheter distal end hole too small
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Cook Inc. medical device recall: Cook Kwart Retro-Inject Ureteral Stent Set: PRODUCT/CATALOG… Official notice ↗
Kwart RetroInject Stent Set (Multi-Length) and Salle Intraoperative Pyeloplasty Stent Set Instructions for Use (IFU) did not include a warning for stent knotting.
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Cook Inc. medical device recall: Cook Transseptal Needle Official notice ↗
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.
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Cook Inc. medical device recall: Entuit Secure Gastrointestinal Suture Anchor Set Official notice ↗
There is a potential for difficulty in sliding down the retention mechanism on the sets manufactured with a specific extension spring lot.
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Cook Inc. medical device recall: Check-Flo Performer Introducer Official notice ↗
The products were manufactured with longer than specified sheaths.
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Cook Inc. medical device recall: VentriClear Ventricular Drainage Catheter Set Official notice ↗
This lot of VentriClear failed endotoxin testing. Potential adverse events include immune responses ranging from non-specific febrile reaction to life-threatening…
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Cook Inc. medical device recall: Connecting Tube - Female to Male Luer Lock Official notice ↗
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.
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Cook Inc. medical device recall: StoneBreaker Pneumatic Lithotripter Official notice ↗
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.
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Cook Inc. medical device recall: Advance¿ 35LP Low-Profile PTA Balloon Dilatation Catheter Official notice ↗
Incorrect product labeling. Product labeled as 6mm x 2cm balloon are packaged with a 4mm x 4 cm balloon label and vice-versa.
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Cook Inc. medical device recall: Cook Vacuum Pump Official notice ↗
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…
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Cook Inc. medical device recall: MINC Benchtop Incubator Official notice ↗
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…
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Cook Inc. medical device recall: Norm-Ject Tuberkulin Syringe Official notice ↗
Certain lots of in vitro fertilization (IVF) products were distributed without completed finished device quality testing with potential adverse events that may include…
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Cook Inc. medical device recall: Amplatz Extra Stiff Whisker Wire Guide Official notice ↗
Label does not state that the product is heparin-coated.
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Cook Inc. medical device recall: Mallinckrodt Institute Percutaneous Gastrostomy Set Product Usage:… Official notice ↗
Cook has identified that the affected lots may contain wire guides that were loaded backwards into the wire guide holder.
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Cook Inc. medical device recall: Central Venous Catheter Set Triple Lumen Polyurethane Official notice ↗
Central venous catheters may not fit over guide wire potentially causing procedure delay.
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Cook Inc. medical device recall: OptiLite Multi-Use Holmium Laser Fibers Official notice ↗
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…
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Cook Inc. medical device recall: Vue Optic Visualization Source Official notice ↗
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…
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Cook Inc. medical device recall: Cook Multi-Use Holmium Laser Fibers Official notice ↗
Correction to the product Instructions for Use because the current reprocessing instructions do not provide sufficient detailed information for the cleaning,…
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Cook Inc. medical device recall: Pereyra-Raz Ligature Carrier Official notice ↗
reprocessing instructions do not provide sufficient detailed information for the cleaning, disinfection, and sterilization of these products
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Cook Inc. medical device recall: Willscher Vas Reapproximator Set Official notice ↗
COOK Medical is initiating a voluntary recall of multiple products because the reprocessing instructions do not provide sufficient detailed information for the cleaning,…
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Cook Inc. medical device recall: Bush DL Ureteral Illuminating Catheter Set Bush SL Ureteral… Official notice ↗
Product may overheat, melt, and burn patient.
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Cook Inc. medical device recall: Check-Flo Performer Introducer Official notice ↗
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…
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Cook Inc. medical device recall: Cook Spectrum Minocycline/Rifampin Impregnated Double Lumen Central… Official notice ↗
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…
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Cook Inc. medical device recall: Roadrunner Uniglide Hydrophilic Wire Guide Official notice ↗
Potential coating contamination with glass particles.
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Cook Inc. medical device recall: Beacon Tip Torcon NB Advantage Catheter Catheter Official notice ↗
Increase in reports of polymer degradation of the catheter tip, resulting in tip fracture and/or separation. degradation could include loss of device function,…
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Cook Inc. medical device recall: UltraxxTM Nephrostomy Balloon Set The Ultraxx" Nephrostomy Balloon… Official notice ↗
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…
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Cook Inc. medical device recall: Kopans Breast Lesion Localization Needle The Kopans Breast Lesion… Official notice ↗
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…
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Cook Inc. medical device recall: Flexor Check-Flo Introducer Official notice ↗
Incorrect packaging. Reports of packages labeled as 6.0Fr actually containing 5.0Fr devices.
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Cook Inc. medical device recall: Single Lumen Central Venous Catheter Sets and Trays The subject sets… Official notice ↗
A manufacturing process may lead to catheter tip fracture and or separation. Potential adverse events may include loss of device function, medical intervention to…
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Cook Inc. medical device recall: Shuttle Select Slip-Cath Catheter. Angiographic catheter. For use in… Official notice ↗
Reports of catheter tip splits and or separation. Loss of device function, medical intervention to retrieve separated segment, or complications resulting from separated…
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Cook Inc. medical device recall: VentriClear¿ II Ventricular Drainage Catheter Set. Allows external… Official notice ↗
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…
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Cook Inc. medical device recall: Cook Medical CXI Support Catheter 2.6FR curved catheter and 4.0FR… Official notice ↗
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.…
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Cook Inc. medical device recall: Beacon Tip Torcon NB Advantage Catheter. Angiographic catheter. For… Official notice ↗
Reports of catheter tip splits and or separation. Loss of device function, medical intervention to retrieve separated segment, or complications resulting from separated…
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Cook Inc. medical device recall: Ring Transjugular Intrahepatic Access Set Product Usage: The Ring… Official notice ↗
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…
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Cook Inc. medical device recall: LapSac Surgical Tissue Pouch. The current intended use for the LapSac… Official notice ↗
Includes Information not stated in the intended use.
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Cook Inc. medical device recall: CloverSnare 4-Loop Vascular Retrieval Snare. Product is packaged in a… Official notice ↗
This remedial action is the result of six product complaints associated with separation of the snare from the distal tip of the wire.
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Cook, Inc. medical device recall: Zilver¿ PTX¿ Drug-Eluting Peripheral Stent - 6 mm X 80mm Official notice ↗
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…
Firm names are matched across agencies by name only. Different companies with similar names may be grouped together; check each official notice.