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Cook Incorporated Recalls

61 recalls on record. Search official CPSC, FDA, and USDA datasets for every recall issued for Cook Incorporated.

61Total Recalls
2Critical
425,155Units Affected
Mar 5, 2026Most Recent
All Recalls

Every Cook Incorporated Recall

Sorted by most recent. Click any recall for full details.

61 recalls
High RiskFDA
Cook Incorporated
COOK MEDICAL Arterial Pressure Monitoring Tray, Reference Part Number APMY-2.5-15-0-2.5 , Order Number G58412; Reference Part Number APMY...
Medical Devices·20 affected·Mar 5, 2026
High RiskFDA
Cook Incorporated
Melker Universal Cuffed Emergency Cricothyrotomy Catheter Set: Reference Part Number C-TCCSB-500-UNI, Order Number G32193; Reference P...
Surgical Devices·476 affected·Mar 5, 2026
High RiskFDA
Cook Incorporated
COOK MEDICAL Cook¿ Strange Bile Duct Stone Exploration Set: Reference Part Number C-CSRC-7.5D-40-STRANGE, Order Number G09108
Medical Devices·49 affected·Mar 5, 2026
High RiskFDA
Cook Incorporated
COOK MEDICAL Wayne Pneumothorax Set: Reference Part Number C-UTPT-1020-WAYNE-IMH, Order Number G56532; Reference Part Number C-UTPT-14...
Medical Devices·104 affected·Mar 5, 2026
High RiskFDA
Cook Incorporated
COOK MEDICAL Blue Rhino¿ G2-Multi Percutaneous Tracheostomy Introducer Tray: Reference Part Number C-PTISY-100-HC-G-NA, Order Number G57...
Medical Devices·441 affected·Mar 5, 2026
High RiskFDA
Cook Incorporated
COOK MEDICAL Approach CTO-18 Micro Wire Guide, Reference Part Number CMW-14-190-18G, Order Number G50788; Reference Part Number CMW-14-30...
Medical Devices·75 affected·Mar 5, 2026
High RiskFDA
Cook Incorporated
COOK MEDICAL Spectrum¿ Central Venous Tray: Reference Part Number C-UQLMYJ-1001J-RSC-ABRM-HC-FST-A-RD, Order Number G44800; Reference ...
Medical Devices·2,348 affected·Mar 5, 2026
High RiskFDA
Cook Incorporated
COOK MEDICAL Spectrum¿ Central Venous Catheter Set: Reference Part Number C-UDLM-401J-ABRM-HC, Order Number G43983; Reference Part Num...
Surgical Devices·5,080 affected·Mar 5, 2026
High RiskFDA
Cook Incorporated
COOK MEDICAL Approach CTO-6 Micro Wire Guide, Reference Part Number CMW-14-190-6G, Order Number G50786
Medical Devices·15 affected·Mar 5, 2026
High RiskFDA
Cook Incorporated
COOK MEDICAL Thal-Quick Chest Tube Tray: Reference Part Number C-TQTSY-3200, Order Number G07242
Medical Devices·2 affected·Mar 5, 2026
High RiskFDA
Cook Incorporated
COOK MEDICAL Blue Rhino G2-Multi Percutaneous Tracheostomy Introducer Set: Reference Part Number C-PTIS-100-HC-G-EU, Order Number G57685...
Medical Devices·916 affected·Mar 5, 2026
High RiskFDA
Cook Incorporated
COOK MEDICAL Multipurpose Drainage Catheter: Reference Part Number ULT8.5-38-25-P-CLMS-8-RH-FS, Order Number G29775
Surgical Devices·20 affected·Mar 5, 2026
High RiskFDA
Cook Incorporated
COOK MEDICAL Ciaglia Blue Rhino Percutaneous Tracheostomy Introducer Set: Reference Part Number C-PTIS-100-FLEX-HC, Order Number G32092;...
Medical Devices·484 affected·Mar 5, 2026
High RiskFDA
Cook Incorporated
COOK MEDICAL NCompass¿ Nitinol Stone Extractor: Reference Part Number C-NTSE-2.4-115-NC3, Order Number G36250; Reference Part Number C...
Medical Devices·70 affected·Mar 5, 2026
High RiskFDA
Cook Incorporated
Flexor Check-Flo Introducers and Sets, Reference Part Numbers: 1) KCFW-9.0-18/38-45-RB-ANL0-HC; 2) KCFW-9.0-18/38-45-RB-ANL1-HC; 3...
Medical Devices·7,952 affected·Nov 26, 2025
High RiskFDA
Cook Incorporated
R¿sch-Uchida Transjugular Liver Access Sets, Reference Part Numbers: RUPS-100; The R¿sch-Uchida Transjugular Liver Access Set is inten...
Diagnostic Devices·23 affected·Nov 26, 2025
High RiskFDA
Cook Incorporated
Check=Flo Performer Introducer, 10.0Fr, Reference Part Number(RPN) REF RCFW-10.0-0-38-30-RB, Order Number (GPN) REF G08686,
Medical Devices·99 affected·Apr 17, 2025
High RiskFDA
Cook Incorporated
Check=Flo Performer Introducer, 14.0Fr, Reference Part Number(RPN) REF RCFW-14.0-0-38-30-RB, Order Number (GPN) REF G08957,
Medical Devices·89 affected·Apr 17, 2025
High RiskFDA
Cook Incorporated
Tornado Embolization Microcoil, intended for embolization of selective vessel supply to arteriovenous malformations and other vascular le...
Medical Devices·2,952 affected·Apr 17, 2025
High RiskFDA
Cook Incorporated
Approach Hydro ST Micro Wire Guide; Catalog prefix HMW Reference Part Numbers: HMW-14-135-ST HMW-14-190-ST HMW-14-300-ST
Medical Devices·5,953 affected·Oct 8, 2024
High RiskFDA
Cook Incorporated
Check-Flo Performer Introducer Set, Reference Part Number RCF-5.0-35-45-J, Order Number G27242. Performer Introducers are designed to per...
Medical Devices·50 affected·Sep 16, 2024
High RiskFDA
Cook Incorporated
Peel-Away Introducer - Intended for the percutaneous introduction of balloon, electrode and closed or non-tapered end catheters into cent...
Surgical Devices·55 affected·Mar 1, 2024
High RiskFDA
Cook Incorporated
Dilator - Intended to be used for dilating puncture sites or catheter tracts for percutaneous placement of devices for vascular and non-v...
Surgical Devices·5,998 affected·Mar 1, 2024
High RiskFDA
Cook Incorporated
Entuit Secure Adjustable Gastrointestinal Suture Anchor Set - Intended for anchoring the anterior wall of the stomach to the abdominal wa...
Surgical Devices·8 affected·Mar 1, 2024
High RiskFDA
Cook Incorporated
Yueh Centesis Disposable Catheter Needle - Intended for use in percutaneous fluid aspirations, such as paracentesis or thoracentesis. ...
Surgical Devices·296 affected·Mar 1, 2024
High RiskFDA
Cook Incorporated
Trocar Needle - Used for dilating puncture sites or catheter tracts for percutaneous placement of devices for vascular and non-vascular a...
Surgical Devices·55 affected·Mar 1, 2024
High RiskFDA
Cook Incorporated
Dilator - Coons Taper - Used for dilating puncture sites or catheter tracts for percutaneous placement of devices for vascular and non-va...
Surgical Devices·4,856 affected·Mar 1, 2024
CriticalFDA
Cook Incorporated
Blue Rhino G2-Multi Percutaneous Tracheostomy Introducer Tray, Reference Part Numbers C-PTISYJ-100-HC-G-EU-FLEX8.5 (G57725), C-PTISYJ-100...
Medical Devices·25,161 affected·Apr 7, 2023
CriticalFDA
Cook Incorporated
Blue Rhino G2-Multi Percutaneous Tracheostomy Introducer Set, Reference Part Numbers C-PTIS-100-HC-G-EU-FLEX7.5 (G57695), C-PTIS-100-HC-G...
Medical Devices·3 affected·Apr 7, 2023
High RiskFDA
Cook Incorporated
Fixed Core Wire Guide (Safe-T-J Curved), Guidewire Reference Part Number/GPN: TSCF-25-180-3 G01602 TSCF-35-180-3 G00902 TSCF-21-260-3...
Medical Devices·9,903 affected·Aug 16, 2022
High RiskFDA
Cook Incorporated
Heavy Double Flexible Tipped Wire Guide, Guidewire Reference Part Number/GPN: THDOC-35-60-0-3 G11949 C-HDOC-18-40-0-2 G09201 C-THDOC-...
Medical Devices·25 affected·Aug 16, 2022
High RiskFDA
Cook Incorporated
Vinyl Connecting Tube, Connecting Tube Reference Part Number/GPN CTU14.0-30-ST G02278 CTU14.0-40-ST G02327 CTU14.0-30 G02791 CTU14.0...
Medical Devices·240 affected·Aug 16, 2022
High RiskFDA
Cook Incorporated
Newton Wire Guide (LT Taper/10cm Distal Flexibility), Guidewire Reference Part Number/GPN: TSFNA-35-145 G00701 TSCFNA-35-145-3 G00561
Medical Devices·42 affected·Aug 16, 2022
High RiskFDA
Cook Incorporated
Bentson Plus Wire Guide (Extra Body/20cm Distal Flexibility with Softened Tip), Guidewire; Reference Part Number: TSFBP-35-180 (GPN G09...
Medical Devices·488 affected·Aug 16, 2022
High RiskFDA
Cook Incorporated
Roadrunner PC Wire Guide (The Firm LT), Guidewire Reference Part Number/GPN RLPC-35-145 G06866
Medical Devices·115 affected·Aug 16, 2022
High RiskFDA
Cook Incorporated
Rosen Curved Wire Guide, Guidewire Reference Part Number/GPN THSCF-35-220-1.5-ROSEN G01623 THSCF-35-80-1.5-ROSEN G01774 THSCF-35-180-...
Medical Devices·5,041 affected·Aug 16, 2022
High RiskFDA
Cook Incorporated
Amplatz extra Stiff Wire Guide, Stiff Guidewire (OUS ONLY); Reference Part Number: THSF-35-145-AES-SGH (GPN G06801) THSF-38-80-AES-SGH...
Medical Devices·204 affected·Aug 16, 2022
High RiskFDA
Cook Incorporated
Fixed Core Wire Guide, Guidewire Reference Part Number/GPN THSCF-25-180-3 G02165 TSCF-25-80-3 G00476
Medical Devices·58 affected·Aug 16, 2022
High RiskFDA
Cook Incorporated
Double Flexible Tipped Wire Guide, Guidewire Reference Part Number/GPN TDOC-35-145-0-3 G00362 C-TDOC-18-50-0-2 G05146 TDOC-35-50-0-3 ...
Medical Devices·150 affected·Aug 16, 2022
High RiskFDA
Cook Incorporated
Cope Mandril Wire Guide (Stainless Steel), Stainless Steel Guidewire Reference Part Number/GPN PMG-18SP-60-COPE G05183 PMG-18SP-100-CO...
Medical Devices·2,748 affected·Aug 16, 2022
High RiskFDA
Cook Incorporated
Torq-Flex Wire Guide Australian Modification, Guidewire Reference Part Number/GPN STF-18-40-AUST G07304
Medical Devices·149 affected·Aug 16, 2022
High RiskFDA
Cook Incorporated
Roadrunner PC Hydrophilic Wire Guide, Hydrophilic Guidewire Reference Part Number/GPN: RPC-035145-0-5 G34131 RPC-035145 G18154 RPC-03...
Medical Devices·56 affected·Aug 16, 2022
High RiskFDA
Cook Incorporated
Roadrunner PC Wire Guide (The Firm), Guidewire Reference Part Number/GPN RPC-35-145 G06979 RPC-35-80 G09534
Medical Devices·363 affected·Aug 16, 2022
High RiskFDA
Cook Incorporated
Bentson Wire Guide (20cm Distal Flexibility with Softened Tip), Guidewire; Reference Part Number: TSFB-35-80 (GPN G01315) TSFB-35-145 ...
Medical Devices·5,571 affected·Aug 16, 2022
High RiskFDA
Cook Incorporated
Lunderquist -Ring Torque Wire Guide, Guidewire Reference Part Number/GPN THSF-35-125-THG G27031 THSF-35-145-THG G27033
Medical Devices·0 affected·Aug 16, 2022
High RiskFDA
Cook Incorporated
Movable Core Wire Guide (Tefcor), Guidewire (OUS ONLY) Reference Part Number/GPN TMT-35-145 G01677
Medical Devices·0 affected·Aug 16, 2022
High RiskFDA
Cook Incorporated
Bentson Wire Guide, Guidewire (OUS ONLY); Reference Part Number: TSMB-35-145 (GPN G27041)
Medical Devices·43 affected·Aug 16, 2022
High RiskFDA
Cook Incorporated
Coons Interventional Wire Guide, Guidewire; Reference Part Number/GPN: THSF-35-145-COONS G02356 THSF-38-145-COONS G02324 THSF-35-180-...
Medical Devices·1,236 affected·Aug 16, 2022