Cook recalls
Cook has 349 recalls on record with the FDA and USDA, the earliest in 2013 and the latest reported on 13 May 2026. 85 are still ongoing. 24 were reported in the last 12 months. The most frequent reason is sterility.
Total recalls 349 since 2013
Last 12 months 24 reported
Class I 48 14% of total
Ongoing 85 latest 13 May 2026
Recalls per month, last 24 months click a bar for that month Severity split
48 14%301 86%0 0%
Ongoing cook recalls 85 active
All cook recalls, newest first 349 total Reported Class Recall Company Reason Where 13 May 2026 Device CLASS I Beacon Tip Centimeter Sizing Catheter RPN/GPN recalled Cook Device Malfunction Nationwide 13 May 2026 Device CLASS I Aurous Centimeter Sizing Catheter RPN recalled by Cook Incorporated Cook Device Malfunction Nationwide 13 May 2026 Device CLASS I Centimeter Sizing Catheter RPN N5.0-35-100-P-10S-Pig-csc recalled Cook Device Malfunction Nationwide 15 Apr 2026 Device CLASS II Medical Cook Staged Extubation Set: Reference recalled Cook Other IN 15 Apr 2026 Device CLASS II Medical Cook¿ Spectrum¿ Central Venous Catheter Tray: Reference recalled Cook Other IN 15 Apr 2026 Device CLASS II Medical Wayne Pneumothorax Tray: Reference recalled by Cook Incorporated Cook Other IN 15 Apr 2026 Device CLASS II Medical Approach Cto-12 Micro Wire Guide: Reference recalled Cook Other IN 15 Apr 2026 Device CLASS II Medical NCompass¿ Nitinol Stone Extractor: Reference recalled Cook Other IN 15 Apr 2026 Device CLASS II Medical Ciaglia Blue Rhino Percutaneous Tracheostomy recalled Cook Other IN 15 Apr 2026 Device CLASS II Medical Multipurpose Drainage Catheter: Reference recalled Cook Other IN 15 Apr 2026 Device CLASS II Medical Blue Rhino G2-Multi Percutaneous Tracheostomy recalled Cook Other IN 15 Apr 2026 Device CLASS II Medical Thal-Quick Chest Tube Tray: Reference recalled Cook Other IN 15 Apr 2026 Device CLASS II Medical Approach Cto-6 Micro Wire Guide, Reference recalled Cook Other IN 15 Apr 2026 Device CLASS II Medical Spectrum¿ Central Venous Catheter Set: Reference recalled Cook Other IN 15 Apr 2026 Device CLASS II Medical Spectrum¿ Central Venous Tray: Reference recalled Cook Other IN 15 Apr 2026 Device CLASS II Medical Approach Cto-18 Micro Wire Guide, Reference recalled Cook Other IN 15 Apr 2026 Device CLASS II Medical Blue Rhino¿ G2-Multi Percutaneous Tracheostomy recalled Cook Other IN 15 Apr 2026 Device CLASS II Medical Wayne Pneumothorax Set: Reference recalled by Cook Incorporated Cook Other IN 15 Apr 2026 Device CLASS II Medical Cook¿ Strange Bile Duct Stone Exploration Set: Reference recalled Cook Other IN 15 Apr 2026 Device CLASS II Melker Universal Cuffed Emergency Cricothyrotomy Catheter recalled Cook Other IN 15 Apr 2026 Device CLASS II Medical Arterial Pressure Monitoring Tray, Reference recalled Cook Other IN 31 Dec 2025 Device CLASS II Ring Transjugular Intrahepatic Access Sets recalled by Cook Incorporated Cook Potency & Assay IN 31 Dec 2025 Device CLASS II R¿sch-Uchida Transjugular Liver Access Sets recalled Cook Potency & Assay IN 31 Dec 2025 Device CLASS II Flexor Check-Flo Introducers and Sets, Reference Part recalled Cook Potency & Assay IN 25 Jun 2025 Device CLASS I Beacon Tip recalled by Cook Incorporated Cook Other IN 28 May 2025 Device CLASS II Check=Flo Performer Introducer, 14., Reference recalled Cook Other Nationwide 28 May 2025 Device CLASS II Check=Flo Performer Introducer, 10., Reference recalled Cook Other Nationwide 21 May 2025 Device CLASS II Tornado Embolization Microcoil, intended recalled by Cook Incorporated Cook Other IN 27 Nov 2024 Device CLASS II Approach CTO Micro Wire Guide, RPN CMW-14-190-, GPN G50789 recalled Cook Other IN 20 Nov 2024 Device CLASS II Approach CTO Micro Wire Guide, Guide Wire recalled by Cook Incorporated Cook Other Nationwide
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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.