Cook recalls
Cook appears in 349 official U.S. recall notices indexed by RecallRadar, most recently on 2026-05-13.
Company names are normalized from agency data (legal suffixes removed), so related firms may appear under separate pages.
- Aurous Centimeter Sizing Catheter RPN N5.0-35-100-P-10S-PIG-CSC-20-01 GPN G47308 Sizing catheters are single-use, sterile catheters with go…
FDA Device · Class I · 2026-05-13 · Cook - Centimeter Sizing Catheter RPN N5.0-35-100-P-10S-PIG-CSC-20 GPN G11916 Catheters for use in angiographic procedures are available in a vari…
FDA Device · Class I · 2026-05-13 · Cook - 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 NR5.0-35-100-P-10S-PIG-C…
FDA Device · Class I · 2026-05-13 · Cook - COOK MEDICAL Ciaglia Blue Rhino Percutaneous Tracheostomy Introducer Set: Reference Part Number C-PTIS-100-FLEX-HC, Order Number G32092
FDA Device · Class II · 2026-04-15 · Cook - COOK MEDICAL Approach CTO-18 Micro Wire Guide, Reference Part Number CMW-14-190-18G, Order Number G50788
FDA Device · Class II · 2026-04-15 · Cook - COOK MEDICAL Cook¿ Strange Bile Duct Stone Exploration Set: Reference Part Number C-CSRC-7.5D-40-STRANGE, Order Number G09108
FDA Device · Class II · 2026-04-15 · Cook - COOK MEDICAL Cook¿ Spectrum¿ Central Venous Catheter Tray: Reference Part Number C-UTLMY-701J-ABRM-CUSTOM-0003, Order Number G56424
FDA Device · Class II · 2026-04-15 · Cook - COOK MEDICAL Wayne Pneumothorax Tray: Reference Part Number C-UTPTY-1400-WAYNE-112497-IMH, Order Number G56537
FDA Device · Class II · 2026-04-15 · Cook - COOK MEDICAL Cook Staged Extubation Set: Reference Part Number C-CAE-14.0-83-EXTU, Order Number G24073
FDA Device · Class II · 2026-04-15 · Cook - COOK MEDICAL Blue Rhino G2-Multi Percutaneous Tracheostomy Introducer Set: Reference Part Number C-PTIS-100-HC-G-EU, Order Number G57685
FDA Device · Class II · 2026-04-15 · Cook - COOK MEDICAL NCompass¿ Nitinol Stone Extractor: Reference Part Number C-NTSE-2.4-115-NC3, Order Number G36250
FDA Device · Class II · 2026-04-15 · Cook - COOK MEDICAL Thal-Quick Chest Tube Tray: Reference Part Number C-TQTSY-3200, Order Number G07242
FDA Device · Class II · 2026-04-15 · Cook - COOK MEDICAL Approach CTO-6 Micro Wire Guide, Reference Part Number CMW-14-190-6G, Order Number G50786
FDA Device · Class II · 2026-04-15 · Cook - COOK MEDICAL Approach CTO-12 Micro Wire Guide: Reference Part Number CMW-14-190-12G, Order Number G50787
FDA Device · Class II · 2026-04-15 · Cook - Melker Universal Cuffed Emergency Cricothyrotomy Catheter Set: Reference Part Number C-TCCSB-500-UNI, Order Number G32193
FDA Device · Class II · 2026-04-15 · Cook - COOK MEDICAL Arterial Pressure Monitoring Tray, Reference Part Number APMY-2.5-15-0-2.5 , Order Number G58412
FDA Device · Class II · 2026-04-15 · Cook - COOK MEDICAL Spectrum¿ Central Venous Catheter Set: Reference Part Number C-UDLM-401J-ABRM-HC, Order Number G43983
FDA Device · Class II · 2026-04-15 · Cook - COOK MEDICAL Wayne Pneumothorax Set: Reference Part Number C-UTPT-1020-WAYNE-IMH, Order Number G56532
FDA Device · Class II · 2026-04-15 · Cook - COOK MEDICAL Multipurpose Drainage Catheter: Reference Part Number ULT8.5-38-25-P-CLMS-8-RH-FS, Order Number G29775
FDA Device · Class II · 2026-04-15 · Cook - COOK MEDICAL Blue Rhino¿ G2-Multi Percutaneous Tracheostomy Introducer Tray: Reference Part Number C-PTISY-100-HC-G-NA, Order Number G57703
FDA Device · Class II · 2026-04-15 · Cook - COOK MEDICAL Spectrum¿ Central Venous Tray: Reference Part Number C-UQLMYJ-1001J-RSC-ABRM-HC-FST-A-RD, Order Number G44800
FDA Device · Class II · 2026-04-15 · Cook - Ring Transjugular Intrahepatic Access Sets, Reference Part Numbers: 1) RTPS-100
FDA Device · Class II · 2025-12-31 · Cook - R¿sch-Uchida Transjugular Liver Access Sets, Reference Part Numbers: RUPS-100
FDA Device · Class II · 2025-12-31 · Cook - Flexor Check-Flo Introducers and Sets, Reference Part Numbers: 1) KCFW-9.0-18/38-45-RB-ANL0-HC
FDA Device · Class II · 2025-12-31 · Cook - Beacon Tip 5.0 Fr Angiographic catheters are designed to facilitate diagnostic and therapeutic procedures
FDA Device · Class I · 2025-06-25 · Cook - Check=Flo Performer Introducer, 10.0Fr, Reference Part Number(RPN) REF RCFW-10.0-0-38-30-RB, Order Number (GPN) REF G08686
FDA Device · Class II · 2025-05-28 · Cook - Check=Flo Performer Introducer, 14.0Fr, Reference Part Number(RPN) REF RCFW-14.0-0-38-30-RB, Order Number (GPN) REF G08957
FDA Device · Class II · 2025-05-28 · Cook - Tornado Embolization Microcoil, intended for embolization of selective vessel supply to arteriovenous malformations and other vascular lesi…
FDA Device · Class II · 2025-05-21 · Cook - Approach CTO Micro Wire Guide, RPN CMW-14-190-25G, GPN G50789
FDA Device · Class II · 2024-11-27 · Cook - Approach Hydro ST Micro Wire Guide
FDA Device · Class II · 2024-11-20 · Cook - Approach CTO Micro Wire Guide, Guide Wire, Catalog Prefix CMW
FDA Device · Class II · 2024-11-20 · Cook - Check-Flo Performer Introducer Set, Reference Part Number RCF-5.0-35-45-J, Order Number G27242
FDA Device · Class II · 2024-10-16 · Cook - Ultrathane Cook-Cope Type Locking Loop Multipurpose Drainage Catheter-ULT12.0-38-45-P-6S-CLM-RH-ntended for percutaneous drainage in a vari…
FDA Device · Class II · 2024-07-03 · Cook - Ultrathane Mac-Loc Locking Loop Multipurpose Drainage Catheter ULT16.0-38-25-P-6S-MCL-HC--Intended for percutaneous drainage in a variety o…
FDA Device · Class II · 2024-07-03 · Cook - Dilator With AQ Hydrophilic Coating - Intended to be used for dilating puncture sites or catheter tracts for percutaneous placement of devi…
FDA Device · Class II · 2024-04-24 · Cook - Dilator - Intended to be used for dilating puncture sites or catheter tracts for percutaneous placement of devices for vascular and non-vas…
FDA Device · Class II · 2024-04-24 · Cook - Yueh Centesis Disposable Catheter Needle - Intended for use in percutaneous fluid aspirations, such as paracentesis or thoracentesis
FDA Device · Class II · 2024-04-24 · Cook - Trocar Needle - Used for dilating puncture sites or catheter tracts for percutaneous placement of devices for vascular and non-vascular app…
FDA Device · Class II · 2024-04-24 · Cook - Peel-Away Introducer - Intended for the percutaneous introduction of balloon, electrode and closed or non-tapered end catheters into centra…
FDA Device · Class II · 2024-04-24 · Cook - Chiba Biopsy Needle - Used for aspiration biopsy
FDA Device · Class II · 2024-04-24 · Cook - Entuit Secure Adjustable Gastrointestinal Suture Anchor Set - Intended for anchoring the anterior wall of the stomach to the abdominal wall…
FDA Device · Class II · 2024-04-24 · Cook - Dilator - Coons Taper - Used for dilating puncture sites or catheter tracts for percutaneous placement of devices for vascular and non-vasc…
FDA Device · Class II · 2024-04-24 · Cook - 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-E…
FDA Device · Class I · 2023-05-17 · Cook - Blue Rhino G2-Multi Percutaneous Tracheostomy Introducer Tray, Reference Part Numbers C-PTISYJ-100-HC-G-EU-FLEX8.5 (G57725), C-PTISYJ-100-H…
FDA Device · Class I · 2023-05-17 · Cook - Cope Mandril Wire Guide (Nitinol), Nitinol Guidewire
FDA Device · Class II · 2022-10-05 · Cook - Bentson Wire Guide, Guidewire (OUS ONLY)
FDA Device · Class II · 2022-10-05 · Cook - Newton Wire Guide (LT Taper/10cm Distal Flexibility), Guidewire Reference Part Number/GPN: TSFNA-35-145 G00701 TSCFNA-35-145-3 G00561
FDA Device · Class II · 2022-10-05 · Cook - Torq-Flex Wire Guide Australian Modification, Guidewire Reference Part Number/GPN STF-18-40-AUST G07304
FDA Device · Class II · 2022-10-05 · Cook - Movable Core Wire Guide (Tefcor), Guidewire (OUS ONLY) Reference Part Number/GPN TMT-35-145 G01677
FDA Device · Class II · 2022-10-05 · Cook - Bentson Wire Guide (20cm Distal Flexibility with Softened Tip), Guidewire
FDA Device · Class II · 2022-10-05 · Cook