Cook Medical recalls

Cook Medical has 53 recalls on record with the FDA and USDA, the earliest in 2014 and the latest reported on 22 Oct 2025. 4 are still ongoing.

Total recalls53since 2014
Last 12 months0reported
Class I24% of total
Ongoing4latest 22 Oct 2025

Recalls per month, last 24 months

click a bar for that month

Severity split

Class I 2 4%Class II 45 85%Class III 6 11%

By year

Ongoing cook medical recalls

4 active

All cook medical recalls, newest first

53 total
ReportedClassRecallCompanyReasonWhere
DeviceCLASS IZenith Alpha 2 Thoracic Endovascular Graft recalledCook MedicalOther27 states
DeviceCLASS IIEchoTip¿ Ultra Endoscopic Ultrasound Access Needle, Echo-19, G31520 recalledCook MedicalOtherIN
DeviceCLASS IIEchoTip¿ Ultra HD Endoscopic Ultrasound Access Needle recalledCook MedicalOtherIN
DeviceCLASS IIMINC+ Benchtop Incubator, Reference recalled by Cook MedicalCook MedicalTemperature Abuse4 states
DeviceCLASS IIDisposable Humidification Flask, Reference recalled by Cook MedicalCook MedicalPackaging DefectsNationwide
DeviceCLASS IIIGunther Tulip Vena Cava Filter Set for Jugular Vein Approach recalledCook MedicalDevice MalfunctionNationwide
DeviceCLASS IIICook Celect Platinum Vena Cava Filter Set for Femoral Vein Approach recalledCook MedicalDevice MalfunctionNationwide
DeviceCLASS IIIGunther Tulip Vena Cava Filter Set for Femoral Vein Approach recalledCook MedicalDevice MalfunctionNationwide
DeviceCLASS IIIGunther Tulip Vena Cava Filter Set for Femoral recalledCook MedicalDevice MalfunctionNationwide
DeviceCLASS IIICook Celect Platinum Vena Cava Filter Set for Jugular Vein Approach recalledCook MedicalDevice MalfunctionNationwide
DeviceCLASS IIICook Celect Platinum Vena Cava Filter Set for Femoral recalledCook MedicalDevice MalfunctionNationwide
DeviceCLASS IIZilver 635 Biliary Stent recalled by Cook Medical IncorporatedCook MedicalOtherNationwide
DeviceCLASS IIZilver 635 Biliary Stent recalled by Cook Medical IncorporatedCook MedicalOtherNationwide
DeviceCLASS IIZilver 635 Biliary Stent recalled by Cook Medical IncorporatedCook MedicalOtherNationwide
DeviceCLASS IIZilver 518 Biliary Stent recalled by Cook Medical IncorporatedCook MedicalOtherNationwide
DeviceCLASS IIZilver Biliary 518 Stent recalled by Cook Medical IncorporatedCook MedicalOtherNationwide
DeviceCLASS IIZilver 635 Biliary Stent recalled by Cook Medical IncorporatedCook MedicalOtherNationwide
DeviceCLASS IIZilver 635 Biliary Stent recalled by Cook Medical IncorporatedCook MedicalOtherNationwide
DeviceCLASS IIZilver 635 Biliary Stent recalled by Cook Medical IncorporatedCook MedicalOtherNationwide
DeviceCLASS IIZilver 635 Biliary Stent recalled by Cook Medical IncorporatedCook MedicalOtherNationwide
DeviceCLASS IIZilver 635 Biliary Stent recalled by Cook Medical IncorporatedCook MedicalOtherNationwide
DeviceCLASS IIZilver 635 Biliary Stent recalled by Cook Medical IncorporatedCook MedicalOtherNationwide
DeviceCLASS IIZilver 518 Biliary Stent recalled by Cook Medical IncorporatedCook MedicalOtherNationwide
DeviceCLASS IIZilver 635 Biliary Stent recalled by Cook Medical IncorporatedCook MedicalOtherNationwide
DeviceCLASS IIZilver 518 Biliary Stent recalled by Cook Medical IncorporatedCook MedicalOtherNationwide
DeviceCLASS IIZilver 518 Biliary Stent recalled by Cook Medical IncorporatedCook MedicalOtherNationwide
DeviceCLASS IIZilver 518 Biliary Stent recalled by Cook Medical IncorporatedCook MedicalOtherNationwide
DeviceCLASS IIZilver 635 Biliary Stent recalled by Cook Medical IncorporatedCook MedicalOtherNationwide
DeviceCLASS IIZilver 635 Biliary Stent recalled by Cook Medical IncorporatedCook MedicalOtherNationwide
DeviceCLASS IIZilver 635 Biliary Stent recalled by Cook Medical IncorporatedCook MedicalOtherNationwide

About this list

Records come from FDA enforcement reports and USDA FSIS notices, grouped by normalised name. A company operating under several names may appear more than once.