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Cook Incorporated FDA Recalls
85 recalls on file across devices, 6 of them Class I and 84 still open. This firm is not matched to a listed company.
Newest first
Class I is the FDA's most serious grade: a reasonable probability of serious harm or death.
| Product |
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| Centimeter Sizing Catheter RPN N5.0-35-100-P-10S-PIG-CSC-20 GPN G11916 Catheters for use in angiographic proceduresClass IApr 2, 2026Marker bands may be at an increased risk of cracking/breakag |
| Beacon Tip Centimeter Sizing Catheter RPN/GPN NR5.0-35-70-P-10S-0-CSC-20 G31213 NR5.0-35-100-P-10S-0-CSC-20 G31214 Class IApr 2, 2026Marker bands may be at an increased risk of cracking/breakag |
| Aurous Centimeter Sizing Catheter RPN N5.0-35-100-P-10S-PIG-CSC-20-01 GPN G47308 Sizing catheters are single-use, sClass IApr 2, 2026Marker bands may be at an increased risk of cracking/breakag |
| COOK MEDICAL Wayne Pneumothorax Tray: Reference Part Number C-UTPTY-1400-WAYNE-112497-IMH, Order Number G56537; ReferClass IIMar 5, 2026Products from the affected device lots were labeled with exp |
| COOK MEDICAL Approach CTO-18 Micro Wire Guide, Reference Part Number CMW-14-190-18G, Order Number G50788; Reference PartClass IIMar 5, 2026Products from the affected device lots were labeled with exp |
| COOK MEDICAL Spectrum¿ Central Venous Catheter Set: Reference Part Number C-UDLM-401J-ABRM-HC, Order Number G43983; RClass IIMar 5, 2026Products from the affected device lots were labeled with exp |
| Melker Universal Cuffed Emergency Cricothyrotomy Catheter Set: Reference Part Number C-TCCSB-500-UNI, Order Number G321Class IIMar 5, 2026Products from the affected device lots were labeled with exp |
| COOK MEDICAL Blue Rhino¿ G2-Multi Percutaneous Tracheostomy Introducer Tray: Reference Part Number C-PTISY-100-HC-G-NA,Class IIMar 5, 2026Products from the affected device lots were labeled with exp |
| COOK MEDICAL Cook¿ Strange Bile Duct Stone Exploration Set: Reference Part Number C-CSRC-7.5D-40-STRANGE, Order Number Class IIMar 5, 2026Products from the affected device lots were labeled with exp |
| COOK MEDICAL Arterial Pressure Monitoring Tray, Reference Part Number APMY-2.5-15-0-2.5 , Order Number G58412; ReferenceClass IIMar 5, 2026Products from the affected device lots were labeled with exp |
| COOK MEDICAL Approach CTO-6 Micro Wire Guide, Reference Part Number CMW-14-190-6G, Order Number G50786Class IIMar 5, 2026Products from the affected device lots were labeled with exp |
| COOK MEDICAL Approach CTO-12 Micro Wire Guide: Reference Part Number CMW-14-190-12G, Order Number G50787; Reference PaClass IIMar 5, 2026Products from the affected device lots were labeled with exp |
| COOK MEDICAL Cook Staged Extubation Set: Reference Part Number C-CAE-14.0-83-EXTU, Order Number G24073Class IIMar 5, 2026Products from the affected device lots were labeled with exp |
| COOK MEDICAL Blue Rhino G2-Multi Percutaneous Tracheostomy Introducer Set: Reference Part Number C-PTIS-100-HC-G-EU, OrClass IIMar 5, 2026Products from the affected device lots were labeled with exp |
| COOK MEDICAL Multipurpose Drainage Catheter: Reference Part Number ULT8.5-38-25-P-CLMS-8-RH-FS, Order Number G29775Class IIMar 5, 2026Products from the affected device lots were labeled with exp |
| COOK MEDICAL Spectrum¿ Central Venous Tray: Reference Part Number C-UQLMYJ-1001J-RSC-ABRM-HC-FST-A-RD, Order Number G44Class IIMar 5, 2026Products from the affected device lots were labeled with exp |
| COOK MEDICAL Ciaglia Blue Rhino Percutaneous Tracheostomy Introducer Set: Reference Part Number C-PTIS-100-FLEX-HC, OrdClass IIMar 5, 2026Products from the affected device lots were labeled with exp |
| COOK MEDICAL Cook¿ Spectrum¿ Central Venous Catheter Tray: Reference Part Number C-UTLMY-701J-ABRM-CUSTOM-0003, Order NClass IIMar 5, 2026Products from the affected device lots were labeled with exp |
| COOK MEDICAL NCompass¿ Nitinol Stone Extractor: Reference Part Number C-NTSE-2.4-115-NC3, Order Number G36250; RefereClass IIMar 5, 2026Products from the affected device lots were labeled with exp |
| COOK MEDICAL Thal-Quick Chest Tube Tray: Reference Part Number C-TQTSY-3200, Order Number G07242Class IIMar 5, 2026Products from the affected device lots were labeled with exp |
| COOK MEDICAL Wayne Pneumothorax Set: Reference Part Number C-UTPT-1020-WAYNE-IMH, Order Number G56532; Reference PartClass IIMar 5, 2026Products from the affected device lots were labeled with exp |
| R¿sch-Uchida Transjugular Liver Access Sets, Reference Part Numbers: RUPS-100; The R¿sch-Uchida Transjugular Liver AcClass IINov 26, 2025Cook Medical identified that products supplied in the affect |
| Flexor Check-Flo Introducers and Sets, Reference Part Numbers: 1) KCFW-9.0-18/38-45-RB-ANL0-HC; 2) KCFW-9.0-18/38-4Class IINov 26, 2025Cook Medical identified that products supplied in the affect |
| Ring Transjugular Intrahepatic Access Sets, Reference Part Numbers: 1) RTPS-100; 2) RTPS-100-10.0; The Ring TransClass IINov 26, 2025Cook Medical identified that products supplied in the affect |
| Beacon Tip 5.0 Fr Angiographic catheters are designed to facilitate diagnostic and therapeutic procedures. Catheters areClass IMay 15, 2025Cook Medical identified that catheters supplied in the affec |
| Tornado Embolization Microcoil, intended for embolization of selective vessel supply to arteriovenous malformations and Class IIApr 17, 2025Cook Medical identified that devices from the affected devic |
| Check=Flo Performer Introducer, 10.0Fr, Reference Part Number(RPN) REF RCFW-10.0-0-38-30-RB, Order Number (GPN) REF G08Class IIApr 17, 2025Cook Medical identified that devices from the affected devic |
| Check=Flo Performer Introducer, 14.0Fr, Reference Part Number(RPN) REF RCFW-14.0-0-38-30-RB, Order Number (GPN) REF G08Class IIApr 17, 2025Cook Medical identified that devices from the affected devic |
| Approach CTO Micro Wire Guide, RPN CMW-14-190-25G, GPN G50789Class IIOct 14, 2024Devices from the affected device lots have labels that state |
| Approach Hydro ST Micro Wire Guide; Catalog prefix HMW Reference Part Numbers: HMW-14-135-ST HMW-14-190-ST HMW-14-Class IIOct 8, 2024Affected device lots have labels that state the incorrect ex |
| Approach CTO Micro Wire Guide, Guide Wire, Catalog Prefix CMW; Reference Part Numbers: CMW-14-190-12G CMW-14-190-18Class IIOct 8, 2024Affected device lots have labels that state the incorrect ex |
| Check-Flo Performer Introducer Set, Reference Part Number RCF-5.0-35-45-J, Order Number G27242. Performer Introducers arClass IISep 16, 2024Cook Medical is conducting removal of a lot of Check-Flo Per |
| Ultrathane Mac-Loc Locking Loop Multipurpose Drainage Catheter ULT16.0-38-25-P-6S-MCL-HC--Intended for percutaneous draiClass IIMay 15, 2024Product labels state the incorrect expiration dates that ex |
| Ultrathane Cook-Cope Type Locking Loop Multipurpose Drainage Catheter-ULT12.0-38-45-P-6S-CLM-RH-ntended for percutaneousClass IIMay 15, 2024Product labels state the incorrect expiration dates that ex |
| Dilator - Coons Taper - Used for dilating puncture sites or catheter tracts for percutaneous placement of devices for vaClass IIMar 1, 2024Packaging may have low seal strength and not meet peel stren |
| Trocar Needle - Used for dilating puncture sites or catheter tracts for percutaneous placement of devices for vascular aClass IIMar 1, 2024Packaging may have low seal strength and not meet peel stren |
| Entuit Secure Adjustable Gastrointestinal Suture Anchor Set - Intended for anchoring the anterior wall of the stomach toClass IIMar 1, 2024Packaging may have low seal strength and not meet peel stren |
| Dilator With AQ Hydrophilic Coating - Intended to be used for dilating puncture sites or catheter tracts for percutaneouClass IIMar 1, 2024Packaging may have low seal strength and not meet peel stren |
| Chiba Biopsy Needle - Used for aspiration biopsy. REFERENCE PART NUMBER (RPN) ORDER NUMBER (GPN): 1) DCHN-18-10.0 Class IIMar 1, 2024Packaging may have low seal strength and not meet peel stren |
| Dilator - Intended to be used for dilating puncture sites or catheter tracts for percutaneous placement of devices for vClass IIMar 1, 2024Packaging may have low seal strength and not meet peel stren |
| Yueh Centesis Disposable Catheter Needle - Intended for use in percutaneous fluid aspirations, such as paracentesis or tClass IIMar 1, 2024Packaging may have low seal strength and not meet peel stren |
| Peel-Away Introducer - Intended for the percutaneous introduction of balloon, electrode and closed or non-tapered end caClass IIMar 1, 2024Packaging may have low seal strength and not meet peel stren |
| Blue Rhino G2-Multi Percutaneous Tracheostomy Introducer Set, Reference Part Numbers C-PTIS-100-HC-G-EU-FLEX7.5 (G57695)Class IApr 7, 2023There were reports from customers that the tracheostomy in t |
| Blue Rhino G2-Multi Percutaneous Tracheostomy Introducer Tray, Reference Part Numbers C-PTISYJ-100-HC-G-EU-FLEX8.5 (G577Class IApr 7, 2023There were reports from customers that the tracheostomy in t |
| Bentson Wire Guide, Guidewire (OUS ONLY); Reference Part Number: TSMB-35-145 (GPN G27041)Class IIAug 16, 2022Cook Medical identified that devices from the affected devic |
| Movable Core Wire Guide (Tapered Tefcor) (OUS ONLY), Guidewire Reference Part Number/GPN TCMTNA-35-145-3 G01678Class IIAug 16, 2022Cook Medical identified that devices from the affected devic |
| Heavy Double Flexible Tipped Wire Guide, Guidewire Reference Part Number/GPN: THDOC-35-60-0-3 G11949 C-HDOC-18-40-0-2Class IIAug 16, 2022Cook Medical identified that devices from the affected devic |
| Bentson Wire Guide (20cm Distal Flexibility with Softened Tip), Guidewire; Reference Part Number: TSFB-35-80 (GPN G013Class IIAug 16, 2022Cook Medical identified that devices from the affected devic |
| Fixed Core Wire Guide (Straight), Guidewire Reference Part Number/GPN: C-SF-18-30 G02261 C-SF-25-40 G01937 TSF-18-26Class IIAug 16, 2022Cook Medical identified that devices from the affected devic |
| Cope Mandril Wire Guide (Stainless Steel), Stainless Steel Guidewire Reference Part Number/GPN PMG-18SP-60-COPE G05183Class IIAug 16, 2022Cook Medical identified that devices from the affected devic |
| Roadrunner PC Wire Guide (The Firm), Guidewire Reference Part Number/GPN RPC-35-145 G06979 RPC-35-80 G09534Class IIAug 16, 2022Cook Medical identified that devices from the affected devic |
| Lunderquist -Ring Torque Wire Guide, Guidewire Reference Part Number/GPN THSF-35-125-THG G27031 THSF-35-145-THG G2703Class IIAug 16, 2022Cook Medical identified that devices from the affected devic |
| Fixed Core Wire Guide, Guidewire Reference Part Number/GPN THSCF-25-180-3 G02165 TSCF-25-80-3 G00476Class IIAug 16, 2022Cook Medical identified that devices from the affected devic |
| Fixed Core Wire Guide (Safe-T-J Curved), Guidewire Reference Part Number/GPN: TSCF-25-180-3 G01602 TSCF-35-180-3 G009Class IIAug 16, 2022Cook Medical identified that devices from the affected devic |
| Rosen Curved Wire Guide, Guidewire Reference Part Number/GPN THSCF-35-220-1.5-ROSEN G01623 THSCF-35-80-1.5-ROSEN G017Class IIAug 16, 2022Cook Medical identified that devices from the affected devic |
| Torq-Flex Wire Guide Australian Modification, Guidewire Reference Part Number/GPN STF-18-40-AUST G07304Class IIAug 16, 2022Cook Medical identified that devices from the affected devic |
| Roadrunner PC Hydrophilic Wire Guide, Hydrophilic Guidewire Reference Part Number/GPN: RPC-035145-0-5 G34131 RPC-0351Class IIAug 16, 2022Cook Medical identified that devices from the affected devic |
| Amplatz extra Stiff Wire Guide, Stiff Guidewire (OUS ONLY); Reference Part Number: THSF-35-145-AES-SGH (GPN G06801) TClass IIAug 16, 2022Cook Medical identified that devices from the affected devic |
| Movable Core Wire Guide (Tefcor), Guidewire (OUS ONLY) Reference Part Number/GPN TMT-35-145 G01677Class IIAug 16, 2022Cook Medical identified that devices from the affected devic |
| Newton Wire Guide (LT Taper/10cm Distal Flexibility), Guidewire Reference Part Number/GPN: TSFNA-35-145 G00701 TSCFNAClass IIAug 16, 2022Cook Medical identified that devices from the affected devic |
| Vinyl Connecting Tube, Connecting Tube Reference Part Number/GPN CTU14.0-30-ST G02278 CTU14.0-40-ST G02327 CTU14.0-3Class IIAug 16, 2022Cook Medical identified that devices from the affected devic |
| Bentson Plus Wire Guide (Extra Body/20cm Distal Flexibility with Softened Tip), Guidewire; Reference Part Number: TSFBClass IIAug 16, 2022Cook Medical identified that devices from the affected devic |
| Roadrunner PC Wire Guide (Nimble), Guidewire Reference Part Number/GPN: RFSPC-35-145 G09607Class IIAug 16, 2022Cook Medical identified that devices from the affected devic |
| Cope Mandril Wire Guide (Nitinol), Nitinol Guidewire; Reference Part Number/GPN: PMG-18SP-60-COPE-NT-ST G09395 PMG-18Class IIAug 16, 2022Cook Medical identified that devices from the affected devic |
| Double Flexible Tipped Wire Guide, Guidewire Reference Part Number/GPN TDOC-35-145-0-3 G00362 C-TDOC-18-50-0-2 G05146Class IIAug 16, 2022Cook Medical identified that devices from the affected devic |
| Roadrunner PC Wire Guide (Nimble Floppy), Guidewire RFPC-35-145 G07914Class IIAug 16, 2022Cook Medical identified that devices from the affected devic |
| Roadrunner PC Wire Guide (The Firm LT), Guidewire Reference Part Number/GPN RLPC-35-145 G06866Class IIAug 16, 2022Cook Medical identified that devices from the affected devic |
| Coons Interventional Wire Guide, Guidewire; Reference Part Number/GPN: THSF-35-145-COONS G02356 THSF-38-145-COONS G02Class IIAug 16, 2022Cook Medical identified that devices from the affected devic |
| Roadrunner UniGlide Hydrophilic Wire Guide REFERENCE PART NUMBER (RPN): HPWA-18-150 ORDER NUMBER (GPN):G56161. ForClass IIJul 19, 2022Product did not meet the acceptance criteria for packaging t |
| Roadrunner PC Hydrophilic Wire Guide REFERENCE PART NUMBER (RPN)RFPC-35-180 ORDER NUMBER (GPN) G07937. For vasculaClass IIJul 19, 2022Product did not meet the acceptance criteria for packaging t |
| Roadrunner UniGlide Hydrophilic Wire Guide REFERENCE PART NUMBER (RPN): HPWS-35-150 ORDER NUMBER (GPN): G56152. Class IIJul 19, 2022Product did not meet the acceptance criteria for packaging t |
| Roadrunner PC Hydrophilic Wire Guide REFERENCE PART NUMBER (RPN): RFSPC-35-180 ORDER NUMBER (GPN) G09608. For vascClass IIJul 19, 2022Product did not meet the acceptance criteria for packaging t |
| Roadrunner UniGlide Hydrophilic Wire Guide REFERENCE PART NUMBER (RPN): HPWAS-35-80 ORDER NUMBER (GPN): G56175. FoClass IIJul 19, 2022Product did not meet the acceptance criteria for packaging t |
| Roadrunner UniGlide Hydrophilic Wire Guide REFERENCE PART NUMBER (RPN): HPWS-35-80 ORDER NUMBER (GPN): G56151. FClass IIJul 19, 2022Product did not meet the acceptance criteria for packaging t |
| Roadrunner PC Hydrophilic Wire Guide REFERENCE PART NUMBER (RPN): RPC-35-180 ORDER NUMBER (GPN):G07518. For vasculClass IIJul 19, 2022Product did not meet the acceptance criteria for packaging t |
| Roadrunner UniGlide Hydrophilic Wire Guide REFERENCE PART NUMBER (RPN): HPWA-35-150 ORDER NUMBER (GPN): G56173. Class IIJul 19, 2022Product did not meet the acceptance criteria for packaging t |
| Roadrunner UniGlide Hydrophilic Wire Guide REFERENCE PART NUMBER (RPN): HPWA-35-80 ORDER NUMBER (GPN): G56172. FClass IIJul 19, 2022Product did not meet the acceptance criteria for packaging t |
| Roadrunner UniGlide Hydrophilic Wire Guide REFERENCE PART NUMBER (RPN): HPWAS-35-150 ORDER NUMBER (GPN): G56176. FClass IIJul 19, 2022Product did not meet the acceptance criteria for packaging t |
| Roadrunner PC Hydrophilic Wire Guide REFERENCE PART NUMBER (RPN):RLPC-35-180 ORDER NUMBER (GPN) G07516. For vasculClass IIJul 19, 2022Product did not meet the acceptance criteria for packaging t |
| Roadrunner UniGlide Hydrophilic Wire Guide REFERENCE PART NUMBER (RPN): HPW-35-150 ORDER NUMBER (GPN):G56149. For Class IIJul 19, 2022Product did not meet the acceptance criteria for packaging t |
| Roadrunner UniGlide Hydrophilic Wire Guide REFERENCE PART NUMBER (RPN): HPWA-18-80 ORDER NUMBER (GPN): G56162. ForClass IIJul 19, 2022Product did not meet the acceptance criteria for packaging t |
| Pressure Monitoring Set, Single-lumen uncoated central venous catheter. RPN C-PMS-250, GPN G02838Class IIMay 25, 2022The products may contain excess coating material on the outs |
| Hilal Embolization Microcoil, RPN MWCE-18-1.0-0-HILAL-01 (GPN G47499); RPN MWCE-18-0.5-0-HILAL-01 (GPN G47498)Class IIMay 5, 2022The loading cartridges included with these devices may conta |
| Nester Embolization Microcoil RPN GPN MWCE-18-5-2-NESTER G52733 MWCE-18-5-3-NEClass IIMay 5, 2022The loading cartridges included with these devices may conta |
| Tornado Embolization Microcoil, RPN GPN MWCE-18S-5/2-TORNADO G08356 MWCEClass IIMay 5, 2022The loading cartridges included with these devices may conta |