Every recall we track for Cook Inc. — 206 in all — plus the complaints and injury reports the public filed about them.
Cook recalls Flexor Check-Flo Introducer Ansel Modification Model KCFW-6.0-18/38-45-RB-ANL0-HC due to mislabeling that may mix 6FR and 7FR devices, potentially causing incorrect use.
Cook recalls Flexor Check-Flo Introducer Ansel Modification Model KCFW-7.0-18/38-45-RB-ANL0-HC due to mislabeling that may mix 6FR and 7FR devices.
Cook recalls Skinny Needle with Chiba Tip (RPN 090010, GPN G14254) due to potential black debris causing local inflammatory reactions. Affected units may need replacement.
Cook recalls transseptal needles with potential rust on interior/exterior that may cause inflammatory reactions, systemic reactions, or permanent impairment. Affected items have specific UDI codes listed in the recall notice.
Cook recalls Transseptal Needle with Catheter (RPN TSN-17-75.0-ENDRYS) due to potential rust on the needle that could cause inflammatory reactions or serious injury.
Cook recalls Flexor Check-Flo Introducer models with incorrect radiopaque marker placement that may cause longer procedures during medical imaging. Affected lots include GPN G09908, lot 13861362.
Cook recalls Flexor Check-Flo Introducer with incorrect radiopaque marker band placement, potentially causing longer procedures during medical imaging. Affected lots may need replacement.
Cook Medical recalls ureteral stent sets with incorrect material that may break during use. Affected models include 7.0Fr. 22-32cm for ESWL procedures. Contact for return or replacement.
Cook recalls Flexor Check-Flo Introducers with specific lot numbers due to potential sheath separation during use, which could cause life-threatening events like vessel injury or hemorrhage.
Cook recalls Flexor Check-Flo Introducers with specific lot numbers due to risk of sheath separation during use, which could lead to life-threatening complications like vessel injury or hemorrhage.
Cook recalls Flexor Check-Flo Introducers with specific lot numbers due to increased risk of sheath separation during use, which could cause life-threatening complications like vessel injury or hemorrhage.
Cook recalls Flexor Check-Flo Introducers with specific lot numbers due to risk of sheath separation causing life-threatening events like embolization or vessel injury during medical procedures.
Cook recalls Flexor Check-Flo Introducers with specific lot numbers due to increased risk of sheath separation during use, which could cause life-threatening events like hemorrhage or vessel injury.
Cook recalls Flexor Check-Flo Introducers with specific lot numbers due to potential sheath separation during use, which could cause life-threatening events like vessel injury or hemorrhage.
Cook recalls Flexor Check-Flo Introducers with specific lot numbers due to increased risk of sheath separation during use, which could cause life-threatening complications like vessel injury or hemorrhage.
Cook recalls Flexor Tuohy-Borst Side-Arm Introducer (Shuttle Select) with specific lot numbers due to increased risk of sheath separation during use, which could cause life-threatening complications.
Cook recalls Flexor Check-Flo Introducers with specific lot numbers due to increased risk of sheath separation during use, which could cause life-threatening complications like vessel injury or hemorrhage.
Cook recalls Flexor Check-Flo Introducers with specific lot numbers due to potential sheath separation during use, which could cause life-threatening complications like vessel injury or hemorrhage.
Cook recalls Flexor Check-Flo Introducers with specific lot numbers due to risk of sheath separation during use, which could cause life-threatening events like vessel injury or hemorrhage.
Cook recalls Flexor Check-Flo Introducers with specific lot numbers due to potential sheath separation during use, which could cause life-threatening complications like vessel injury or hemorrhage.
Cook recalls Flexor Check-Flo Introducers with specific lot numbers due to risk of sheath separation during use, which could cause life-threatening events like embolization or hemorrhage.
Cook recalls Flexor Check-Flo Introducers with specific lot numbers due to risk of sheath separation during use, which could cause life-threatening complications like vessel injury or hemorrhage.
Cook recalls Flexor Tuohy-Borst Side-Arm Introducers with specific lot numbers due to potential sheath separation causing life-threatening events during medical procedures.
Cook recalls Flexor Check-Flo Introducers with specific lot numbers due to potential sheath separation causing life-threatening events like vessel injury or hemorrhage.
Cook recalls Flexor Check-Flo Introducers with specific lot numbers due to potential sheath separation during use, which could cause life-threatening complications like vessel injury or hemorrhage.
Cook recalls Flexor Check-Flo Introducers with specific lot numbers due to risk of sheath separation during use, which may cause life-threatening complications like vessel injury or hemorrhage.
Cook recalls Flexor Check-Flo Introducers with specific lot numbers due to potential sheath separation during use, which could cause life-threatening complications like hemorrhage or vessel injury.
Cook recalls Flexor Check-Flo Introducers with specific lot numbers due to risk of sheath separation during use, which could cause life-threatening events like vessel injury or hemorrhage.
Cook recalls Flexor Check-Flo Introducers with specific lot numbers due to risk of sheath separation during use, which could cause life-threatening events like hemorrhage or vessel injury.
Cook recalls Fixed Core Wire Guide RPN TSCF-35-260-3 with possible bent wire or loose foreign matter from manufacturing defects.
Cook recalls neonatal nephrostomy sets with shortened indwell time from 4 months to 4 weeks. Affected sets may cause complications if used longer than recommended.
Cook recalls pediatric nephrostomy stent sets with reference part numbers 080208-S6/S7 and order numbers G15034/G15035 due to reduced indwell time from 4 months to 4 weeks. The current instructions for use are being updated.
Cook Inc. recalls Zenith Alpha Abdominal Endovascular Grafts with excess glue in the handle that may prevent proper deployment. Affected units have specific reference part numbers and lot numbers listed in the recall notice.
Cook recalls Universa Soft Ureteral Stent Sets (UFH-526) due to incorrect outer box labeling that may confuse with Firm Stent Sets. This could lead to improper use.
Cook recalls Zenith Alpha Abdominal Endovascular Grafts with catalog prefix ZIMB due to potential damaged bushing that could prevent proper deployment. Affected units may need replacement.
Cook recalls Pressure Monitoring Tray model C-PMSY G02854 with lot numbers 9402033-10145133 due to potential excess coating causing needle occlusion. Consumers should contact Cook for details.
Cook recalls Pressure Monitoring Set C-PMS G02838 with lot numbers 8910219-10148417 due to potential excess coating on needles that could cause blockage during use.
Cook Inc. recalls Formula 418 Renal Balloon-Expandable Stents (lot 10153876) due to potential dislodgement during deployment, which may require additional intervention. Learn if your stent is affected and what to do.
Cook recalls Pericardiocentesis Set with incorrect printed expiration dates. This may lead to improper use of medical devices. Affected units include specific part numbers and lot numbers.
Cook recalls Spectrum Central Venous Catheter Tray with incorrect printed expiration dates. This may lead to improper use of medical devices. Affected units include specific part numbers and lot numbers.
Cook recalls Zenith Alpha Spiral-Z Endovascular Leg grafts (catalog prefix ZISL) due to potential thrombus formation and lumen occlusion risks. Product not distributed in the USA.
Cook recalls specific lots of Dawson-Mueller Drainage Catheter due to potential leakage from Mac-Loc hub assembly. Affected units may cause fluid buildup; contact for return or replacement.
Cook recalls specific CrossCath Support Catheters due to potential radiopaque marker bands being too loose or tight, which could affect medical procedures. Affected units include model CXC3.0-1.9-14-90-P-NS-0 with order number G51572.
Cook recalls CrossCath Support Catheters with potential loose or tight radiopaque markers that could affect imaging during procedures. Affected units have specific lot numbers and order numbers.
Cook recalls CrossCath Support Catheters with potential loose or tight radiopaque markers that could affect imaging accuracy during vascular procedures. Affected units include specific lot numbers and order numbers.
Cook recalls CrossCath Support Catheters with potential loose or tight radiopaque marker bands that could affect imaging during vascular procedures. Affected units include specific model numbers and lot numbers.
Cook recalls Torcon NB Advantage Catheters due to potential sterility compromise from undersealed packaging. Affected lot numbers include 9908469, 9911359, 9936124. Consumers should check their product details.
Cook recalls Torcon NB Advantage Catheters due to potential sterility compromise from undersealed packaging. Affected lots include NS9903072 through NS9942737. Consumers should contact Cook for details.
Cook recalls Torcon NB Advantage Catheters due to potential sterility compromise from undersealed packaging. Affected units have specific lot numbers and were sold for vascular procedures. Consumers should contact Cook for details.
Cook recalls Torcon NB Advantage Catheters due to potential sterility compromise from undersealed packaging. Affected units may be contaminated and should be discarded or returned.
Cook recalls Torcon NB Advantage Catheters due to potential sterility compromise from undersealed packaging. Affected lot numbers include 9698823 to 9719485. Consumers should check packaging for these numbers and contact Cook for details.
Cook recalls Torcon NB Advantage Catheters due to potential sterility compromise from undersealed packaging. Affected units have specific lot numbers and UDI codes. Consumers should contact Cook for details.
Cook recalls Torcon NB Advantage Catheters due to potential sterility compromise from undersealed packaging. Affected units have specific lot numbers and were sold for vascular procedures. Consumers should contact Cook for details.
Cook recalls Torcon NB Advantage Catheters due to potential sterility compromise from undersealed packaging. Affected units have specific lot numbers and UDI codes. Consumers should check their product details and contact Cook for guidance.
Cook recalls Torcon NB Advantage Catheters with undersealed packaging pouches that may compromise sterility. Affected lot numbers include 9696901, 9700384, 9701377, 9708543, 9709229. Contact Cook for details.
Cook recalls Torcon NB Advantage Catheters due to potential sterility compromise from undersealed packaging. Affected units may have contaminated products that could cause infection during medical procedures.
Cook recalls Torcon NB Advantage Catheters due to potential sterility compromise from undersealed packaging. Affected units have specific lot numbers and UDI codes. Consumers should check their product details to determine if recalled.
Cook recalls Torcon NB Advantage Catheters due to potential sterility compromise from undersealed packaging. Affected units have specific lot numbers and UDIs. Consumers should contact Cook for details.
Cook recalls Torcon NB Advantage Catheters due to potential sterility compromise from undersealed packaging pouches. Affected units sold in specific lots and UDI numbers. Consumers should check product details and contact Cook for remedy.
Cook recalls Torcon NB Advantage Catheters due to potential sterility compromise from undersealed packaging. Affected units have specific lot numbers and UDI codes. Consumers should check their product details to determine if recalled.
