FDA recall record · openFDA
Cook Incorporated
44 FDA recalls on record (2023–2026) — 44 device. 44 still ongoing.
6
Class I (most serious)
38
Class II
0
Class III
44
ongoing
How to read this. A recall count is not a quality verdict — large manufacturers recall more simply by volume, and a voluntary recall is the safety system working as intended. The signal to weight is the Class I count (the FDA's most-serious tier — reasonable probability of serious harm or death) and whether recalls are still ongoing. Most recalls are Class II/III. "Ongoing" reflects openFDA's last-published status — device recalls often stay marked ongoing long after they're resolved in practice; confirm current status at the FDA.
Most common reasons
Products from the affected device lots were labeled with expiration dates that exceed the true shelf life. 18
Packaging may have low seal strength and not meet peel strength specifications, compromising device sterility 8
Cook Medical identified that products supplied in the affected device lots may have been manufactured out of specificati 3
Marker bands may be at an increased risk of cracking/breakage. Potential adverse events that may result include increase 3
Cook Medical identified that devices from the affected device lots may contain the incorrectly sized introducer sheath. 2
Recalls
Centimeter Sizing Catheter RPN N5.0-35-100-P-10S-PIG-CSC-20 GPN G11916 Catheters for use in angiographic procedures Class I 2026-04-02 Aurous Centimeter Sizing Catheter RPN N5.0-35-100-P-10S-PIG-CSC-20-01 GPN G47308 Sizing catheters are single-use, s Class I 2026-04-02 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 I 2026-04-02 Beacon Tip 5.0 Fr Angiographic catheters are designed to facilitate diagnostic and therapeutic procedures. Catheters are Class I 2025-05-15 Blue Rhino G2-Multi Percutaneous Tracheostomy Introducer Tray, Reference Part Numbers C-PTISYJ-100-HC-G-EU-FLEX8.5 (G577 Class I 2023-04-07 Blue Rhino G2-Multi Percutaneous Tracheostomy Introducer Set, Reference Part Numbers C-PTIS-100-HC-G-EU-FLEX7.5 (G57695) Class I 2023-04-07 COOK MEDICAL Arterial Pressure Monitoring Tray, Reference Part Number APMY-2.5-15-0-2.5 , Order Number G58412; Reference Class II 2026-03-05 Melker Universal Cuffed Emergency Cricothyrotomy Catheter Set: Reference Part Number C-TCCSB-500-UNI, Order Number G321 Class II 2026-03-05 COOK MEDICAL Cook¿ Strange Bile Duct Stone Exploration Set: Reference Part Number C-CSRC-7.5D-40-STRANGE, Order Number Class II 2026-03-05 COOK MEDICAL Wayne Pneumothorax Set: Reference Part Number C-UTPT-1020-WAYNE-IMH, Order Number G56532; Reference Part Class II 2026-03-05 COOK MEDICAL Blue Rhino¿ G2-Multi Percutaneous Tracheostomy Introducer Tray: Reference Part Number C-PTISY-100-HC-G-NA, Class II 2026-03-05 COOK MEDICAL Approach CTO-18 Micro Wire Guide, Reference Part Number CMW-14-190-18G, Order Number G50788; Reference Part Class II 2026-03-05 COOK MEDICAL Spectrum¿ Central Venous Tray: Reference Part Number C-UQLMYJ-1001J-RSC-ABRM-HC-FST-A-RD, Order Number G44 Class II 2026-03-05 COOK MEDICAL Spectrum¿ Central Venous Catheter Set: Reference Part Number C-UDLM-401J-ABRM-HC, Order Number G43983; R Class II 2026-03-05 COOK MEDICAL Approach CTO-6 Micro Wire Guide, Reference Part Number CMW-14-190-6G, Order Number G50786 Class II 2026-03-05 COOK MEDICAL Thal-Quick Chest Tube Tray: Reference Part Number C-TQTSY-3200, Order Number G07242 Class II 2026-03-05 COOK MEDICAL Blue Rhino G2-Multi Percutaneous Tracheostomy Introducer Set: Reference Part Number C-PTIS-100-HC-G-EU, Or Class II 2026-03-05 COOK MEDICAL Multipurpose Drainage Catheter: Reference Part Number ULT8.5-38-25-P-CLMS-8-RH-FS, Order Number G29775 Class II 2026-03-05 COOK MEDICAL Ciaglia Blue Rhino Percutaneous Tracheostomy Introducer Set: Reference Part Number C-PTIS-100-FLEX-HC, Ord Class II 2026-03-05 COOK MEDICAL NCompass¿ Nitinol Stone Extractor: Reference Part Number C-NTSE-2.4-115-NC3, Order Number G36250; Refere Class II 2026-03-05 COOK MEDICAL Approach CTO-12 Micro Wire Guide: Reference Part Number CMW-14-190-12G, Order Number G50787; Reference Pa Class II 2026-03-05 COOK MEDICAL Wayne Pneumothorax Tray: Reference Part Number C-UTPTY-1400-WAYNE-112497-IMH, Order Number G56537; Refer Class II 2026-03-05 COOK MEDICAL Cook¿ Spectrum¿ Central Venous Catheter Tray: Reference Part Number C-UTLMY-701J-ABRM-CUSTOM-0003, Order N Class II 2026-03-05 COOK MEDICAL Cook Staged Extubation Set: Reference Part Number C-CAE-14.0-83-EXTU, Order Number G24073 Class II 2026-03-05 Check=Flo Performer Introducer, 10.0Fr, Reference Part Number(RPN) REF RCFW-10.0-0-38-30-RB, Order Number (GPN) REF G08 Class II 2025-04-17 Flexor Check-Flo Introducers and Sets, Reference Part Numbers: 1) KCFW-9.0-18/38-45-RB-ANL0-HC; 2) KCFW-9.0-18/38-4 Class II 2025-11-26 Check=Flo Performer Introducer, 14.0Fr, Reference Part Number(RPN) REF RCFW-14.0-0-38-30-RB, Order Number (GPN) REF G08 Class II 2025-04-17 Tornado Embolization Microcoil, intended for embolization of selective vessel supply to arteriovenous malformations and Class II 2025-04-17 R¿sch-Uchida Transjugular Liver Access Sets, Reference Part Numbers: RUPS-100; The R¿sch-Uchida Transjugular Liver Ac Class II 2025-11-26 Ring Transjugular Intrahepatic Access Sets, Reference Part Numbers: 1) RTPS-100; 2) RTPS-100-10.0; The Ring Trans Class II 2025-11-26 Check-Flo Performer Introducer Set, Reference Part Number RCF-5.0-35-45-J, Order Number G27242. Performer Introducers ar Class II 2024-09-16 Peel-Away Introducer - Intended for the percutaneous introduction of balloon, electrode and closed or non-tapered end ca Class II 2024-03-01 Dilator - Intended to be used for dilating puncture sites or catheter tracts for percutaneous placement of devices for v Class II 2024-03-01 Entuit Secure Adjustable Gastrointestinal Suture Anchor Set - Intended for anchoring the anterior wall of the stomach to Class II 2024-03-01 Yueh Centesis Disposable Catheter Needle - Intended for use in percutaneous fluid aspirations, such as paracentesis or t Class II 2024-03-01 Approach Hydro ST Micro Wire Guide; Catalog prefix HMW Reference Part Numbers: HMW-14-135-ST HMW-14-190-ST HMW-14- Class II 2024-10-08 Trocar Needle - Used for dilating puncture sites or catheter tracts for percutaneous placement of devices for vascular a Class II 2024-03-01 Dilator - Coons Taper - Used for dilating puncture sites or catheter tracts for percutaneous placement of devices for va Class II 2024-03-01 Approach CTO Micro Wire Guide, Guide Wire, Catalog Prefix CMW; Reference Part Numbers: CMW-14-190-12G CMW-14-190-18 Class II 2024-10-08 Approach CTO Micro Wire Guide, RPN CMW-14-190-25G, GPN G50789 Class II 2024-10-14 Ultrathane Mac-Loc Locking Loop Multipurpose Drainage Catheter ULT16.0-38-25-P-6S-MCL-HC--Intended for percutaneous drai Class II 2024-05-15 Dilator With AQ Hydrophilic Coating - Intended to be used for dilating puncture sites or catheter tracts for percutaneou Class II 2024-03-01 Ultrathane Cook-Cope Type Locking Loop Multipurpose Drainage Catheter-ULT12.0-38-45-P-6S-CLM-RH-ntended for percutaneous Class II 2024-05-15 Chiba Biopsy Needle - Used for aspiration biopsy. REFERENCE PART NUMBER (RPN) ORDER NUMBER (GPN): 1) DCHN-18-10.0 Class II 2024-03-01
RECORDED — these are the FDA's published recall enforcement records (openFDA). Recalls are listed under the exact firm name as filed; a large manufacturer may also file under name variants, so this may not be the company's complete cross-variant record — confirm at the FDA recall database. This page informs and routes; it is not medical advice or a verdict on the company.