Cook Recalls
266 recalls on record · December 1, 1969 to December 29, 2021 · Medical Devices, Vehicles
Recalls by year
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Count of recall notices naming this brand, by the year the recall was announced. A quiet year is not proof of a safe year.
Also filed under
The recall feeds record what looks like the same company under more than one name:
October 21, 2020Medical DevicesFDA
Cook Inc. recalls Pediatric Nephrostomy Stent Set, Reference Part Numbers 080208-S6 and 080208-S7, Order Numbers G15034 and G15035. The s
Hazard: 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.
October 21, 2020Medical DevicesFDA
Cook Inc. recalls Percutaneous Neonatal Pigtail Nephrostomy Set, Reference Part Number 080106, Order Number G14508. The set contains a 22
Hazard: 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.
September 23, 2020Medical DevicesFDA
Cook Inc. recalls Cook Medical Universa Soft Ureteral Stent Sets-5 FR 26 cm Reference part Number: UFH-526 - Product Usage: Used for tempo
Hazard: 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.
September 23, 2020Medical DevicesFDA
Cook Inc. recalls Zenith Alpha Abdominal Endovascular Graft - Distributed OUS only. Indicated for the endovascular treatment of patients
Hazard: 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
July 15, 2020Medical DevicesFDA
Cook Inc. recalls Zenith Alpha Abdominal Endovascular Graft, Catalog Prefix ZIMB - Product Usage: is indicated for the endovascular treat
Hazard: 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.
June 10, 2020Medical DevicesFDA
Cook Inc. recalls Pressure Monitoring Tray, C-PMSY, G02854
Hazard: 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.
June 10, 2020Medical DevicesFDA
Cook Inc. recalls Pressure Monitoring Set, C-PMS, G02838
Hazard: 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.
May 20, 2020Medical DevicesFDA
Cook Inc. recalls Formula 418 Renal Balloon-Expandable Stent, RPN FOR418-18-80-6-12, Order Number (GPN) G56611 Balloon-expandable stent
Hazard: 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 unintended location.
April 1, 2020Medical DevicesFDA
Cook Inc. recalls Spectrum Central Venous Catheter Tray, Irrigation Catheter, Reference Part Number C-UDLMY-401 J-ABRM-HC-IHl-FST, Order N
Hazard: The printed expiration dates are incorrect.
April 1, 2020Medical DevicesFDA
Cook Inc. recalls Pericardiocentesis Set, Irrigation Catheter, Reference Part Number C-PCS-700-TORONT0-042997, Order Number G10643
Hazard: The printed expiration dates are incorrect.
March 4, 2020Medical DevicesFDA
Cook Inc. recalls Zenith Alpha Spiral-Z Endovascular Leg, Catalog Prefix ZISL. The product is an endovascular graft.
Hazard: 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 Sizing Worksheet to include associated information.
February 12, 2020Medical DevicesFDA
Cook Inc. recalls Universa Soft Ureteral Stent, Global Product No. G49887 G49933 G49934 G49937 G49940 G49941 G49942 G49945 G49947
Hazard: 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.
February 12, 2020Medical DevicesFDA
Cook Inc. recalls Universa Firm Ureteral Stent, Global Product No. G49864 G49865 G49866 G49867 G49868 G49869 G49870 G49874 G49875
Hazard: 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.
February 12, 2020Medical DevicesFDA
Cook Inc. recalls Sof-Flex Multi-Lenqth Ureteral Stent Set, Global Product No. G14773 G15000 G14867 G14951 G17852
Hazard: 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.
February 12, 2020Medical DevicesFDA
Cook Inc. recalls Sof-Flex Double Pigtail Ureteral Stent Set, Global Product No. G15076 G14906 G14840 G14865 G17128
Hazard: 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.
February 12, 2020Medical DevicesFDA
Cook Inc. recalls Kwart Retro-Inject Ureteral Stent Set, Global Product No. G15016 G14836 G14885 G14887 G17151
Hazard: 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.
February 12, 2020Medical DevicesFDA
Cook Inc. recalls C-Flex Double Pigtail Ureteral Stent Set, Global Product No. G14364 G14365 G14367
Hazard: 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.
February 12, 2020Medical DevicesFDA
Cook Inc. recalls Bander Ureteral Diversion Open-End Stent Set, Global Product No. G14822 G14823
Hazard: 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.
February 12, 2020Medical DevicesFDA
Cook Inc. recalls Urethral Dilator Set, Global Product No. G14185
Hazard: 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.
February 12, 2020Medical DevicesFDA
Cook Inc. recalls Urethral Dilation Balloon Catheter with Open Tip , Global Product No. G17844
Hazard: 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.
February 12, 2020Medical DevicesFDA
Cook Inc. recalls Percutaneous Pigtail Nephrostomy Set , Global Product No. G14094 G14095 G14899 G14329
Hazard: 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.
February 12, 2020Medical DevicesFDA
Cook Inc. recalls Percutaneous Malecot Nephrostomy Set, Global Product No. G16714 G19107 G19108
Hazard: 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.
February 12, 2020Medical DevicesFDA
Cook Inc. recalls Percutaneous Entry Set, Nephrostomy Catheter, Global Product No. G14649
Hazard: 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.
February 12, 2020Medical DevicesFDA
Cook Inc. recalls Angled Tip Ureteral Catheter Set with Bentson PTFE Wire Guide, Ureteral Catheter, Global Product No. G19108 G14587 G15
Hazard: 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.
February 12, 2020Medical DevicesFDA
Cook Inc. recalls Angled Tip Ureteral Catheter Set, Ureteral Catheter, Global Product No. G14598
Hazard: 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.
February 12, 2020Medical DevicesFDA
Cook Inc. recalls Wire Guide, Guidewire, Global Product Number G14326
Hazard: 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.
February 12, 2020Medical DevicesFDA
Cook Inc. recalls Roadrunner Hydrophilic PC Wire Guide, Guidewire, Global Product Number G18629, G17866
Hazard: 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.
February 12, 2020Medical DevicesFDA
Cook Inc. recalls PTFE Wire Guide, Guidewire, Global Product Number 638813 635413-10
Hazard: 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.
February 12, 2020Medical DevicesFDA
Cook Inc. recalls Heavy Duty PTFE Wire Guide, Guidewire, Global Product Number G14323 G14260 G14260
Hazard: 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.
February 12, 2020Medical DevicesFDA
Cook Inc. recalls Fixed Core Straight Safety Wire Guide, Guidewire, Global Product Number G14285
Hazard: 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.