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Cook Incorporated Recalls
85 recalls on record · June 15, 2022 to May 13, 2026 · Medical Devices
Recalls by year
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26
Count of recall notices naming this brand, by the year the recall was announced. A quiet year is not proof of a safe year.
Also filed under
The recall feeds record what looks like the same company under more than one name:
May 13, 2026Medical DevicesFDA
Cook Incorporated recalls 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
Hazard: Marker bands may be at an increased risk of cracking/breakage. Potential adverse events that may result include increased procedural time, harms associated with device fragmentation/separation, and vessel injury. In a worst-case scenario, device fragmentation and separation may cause life-threatening harm or death.
May 13, 2026Medical DevicesFDA
Cook Incorporated recalls Aurous Centimeter Sizing Catheter RPN N5.0-35-100-P-10S-PIG-CSC-20-01 GPN G47308 Sizing catheters are single-use, s
Hazard: Marker bands may be at an increased risk of cracking/breakage. Potential adverse events that may result include increased procedural time, harms associated with device fragmentation/separation, and vessel injury. In a worst-case scenario, device fragmentation and separation may cause life-threatening harm or death.
May 13, 2026Medical DevicesFDA
Cook Incorporated recalls Centimeter Sizing Catheter RPN N5.0-35-100-P-10S-PIG-CSC-20 GPN G11916 Catheters for use in angiographic procedures
Hazard: Marker bands may be at an increased risk of cracking/breakage. Potential adverse events that may result include increased procedural time, harms associated with device fragmentation/separation, and vessel injury. In a worst-case scenario, device fragmentation and separation may cause life-threatening harm or death.
April 15, 2026Medical DevicesFDA
Cook Incorporated recalls COOK MEDICAL Wayne Pneumothorax Tray: Reference Part Number C-UTPTY-1400-WAYNE-112497-IMH, Order Number G56537; Refer
Hazard: Products from the affected device lots were labeled with expiration dates that exceed the true shelf life.
April 15, 2026Medical DevicesFDA
Cook Incorporated recalls COOK MEDICAL Wayne Pneumothorax Set: Reference Part Number C-UTPT-1020-WAYNE-IMH, Order Number G56532; Reference Part
Hazard: Products from the affected device lots were labeled with expiration dates that exceed the true shelf life.
April 15, 2026Medical DevicesFDA
Cook Incorporated recalls COOK MEDICAL Thal-Quick Chest Tube Tray: Reference Part Number C-TQTSY-3200, Order Number G07242
Hazard: Products from the affected device lots were labeled with expiration dates that exceed the true shelf life.
April 15, 2026Medical DevicesFDA
Cook Incorporated recalls COOK MEDICAL Spectrum¿ Central Venous Tray: Reference Part Number C-UQLMYJ-1001J-RSC-ABRM-HC-FST-A-RD, Order Number G44
Hazard: Products from the affected device lots were labeled with expiration dates that exceed the true shelf life.
April 15, 2026Medical DevicesFDA
Cook Incorporated recalls COOK MEDICAL Spectrum¿ Central Venous Catheter Set: Reference Part Number C-UDLM-401J-ABRM-HC, Order Number G43983; R
Hazard: Products from the affected device lots were labeled with expiration dates that exceed the true shelf life.
April 15, 2026Medical DevicesFDA
Cook Incorporated recalls COOK MEDICAL NCompass¿ Nitinol Stone Extractor: Reference Part Number C-NTSE-2.4-115-NC3, Order Number G36250; Refere
Hazard: Products from the affected device lots were labeled with expiration dates that exceed the true shelf life.
April 15, 2026Medical DevicesFDA
Cook Incorporated recalls COOK MEDICAL Multipurpose Drainage Catheter: Reference Part Number ULT8.5-38-25-P-CLMS-8-RH-FS, Order Number G29775
Hazard: Products from the affected device lots were labeled with expiration dates that exceed the true shelf life.
April 15, 2026Medical DevicesFDA
Cook Incorporated recalls Melker Universal Cuffed Emergency Cricothyrotomy Catheter Set: Reference Part Number C-TCCSB-500-UNI, Order Number G321
Hazard: Products from the affected device lots were labeled with expiration dates that exceed the true shelf life.
April 15, 2026Medical DevicesFDA
Cook Incorporated recalls COOK MEDICAL Cook¿ Strange Bile Duct Stone Exploration Set: Reference Part Number C-CSRC-7.5D-40-STRANGE, Order Number
Hazard: Products from the affected device lots were labeled with expiration dates that exceed the true shelf life.
April 15, 2026Medical DevicesFDA
Cook Incorporated recalls COOK MEDICAL Cook¿ Spectrum¿ Central Venous Catheter Tray: Reference Part Number C-UTLMY-701J-ABRM-CUSTOM-0003, Order N
Hazard: Products from the affected device lots were labeled with expiration dates that exceed the true shelf life.
April 15, 2026Medical DevicesFDA
Cook Incorporated recalls COOK MEDICAL Cook Staged Extubation Set: Reference Part Number C-CAE-14.0-83-EXTU, Order Number G24073
Hazard: Products from the affected device lots were labeled with expiration dates that exceed the true shelf life.
April 15, 2026Medical DevicesFDA
Cook Incorporated recalls COOK MEDICAL Ciaglia Blue Rhino Percutaneous Tracheostomy Introducer Set: Reference Part Number C-PTIS-100-FLEX-HC, Ord
Hazard: Products from the affected device lots were labeled with expiration dates that exceed the true shelf life.
April 15, 2026Medical DevicesFDA
Cook Incorporated recalls COOK MEDICAL Blue Rhino¿ G2-Multi Percutaneous Tracheostomy Introducer Tray: Reference Part Number C-PTISY-100-HC-G-NA,
Hazard: Products from the affected device lots were labeled with expiration dates that exceed the true shelf life.
April 15, 2026Medical DevicesFDA
Cook Incorporated recalls COOK MEDICAL Blue Rhino G2-Multi Percutaneous Tracheostomy Introducer Set: Reference Part Number C-PTIS-100-HC-G-EU, Or
Hazard: Products from the affected device lots were labeled with expiration dates that exceed the true shelf life.
April 15, 2026Medical DevicesFDA
Cook Incorporated recalls COOK MEDICAL Arterial Pressure Monitoring Tray, Reference Part Number APMY-2.5-15-0-2.5 , Order Number G58412; Reference
Hazard: Products from the affected device lots were labeled with expiration dates that exceed the true shelf life.
April 15, 2026Medical DevicesFDA
Cook Incorporated recalls COOK MEDICAL Approach CTO-18 Micro Wire Guide, Reference Part Number CMW-14-190-18G, Order Number G50788; Reference Part
Hazard: Products from the affected device lots were labeled with expiration dates that exceed the true shelf life.
April 15, 2026Medical DevicesFDA
Cook Incorporated recalls COOK MEDICAL Approach CTO-12 Micro Wire Guide: Reference Part Number CMW-14-190-12G, Order Number G50787; Reference Pa
Hazard: Products from the affected device lots were labeled with expiration dates that exceed the true shelf life.
April 15, 2026Medical DevicesFDA
Cook Incorporated recalls COOK MEDICAL Approach CTO-6 Micro Wire Guide, Reference Part Number CMW-14-190-6G, Order Number G50786
Hazard: Products from the affected device lots were labeled with expiration dates that exceed the true shelf life.
December 31, 2025Medical DevicesFDA
Cook Incorporated recalls R¿sch-Uchida Transjugular Liver Access Sets, Reference Part Numbers: RUPS-100; The R¿sch-Uchida Transjugular Liver Ac
Hazard: Cook Medical identified that products supplied in the affected device lots may have been manufactured out of specification. Impacted products may have been cut to the incorrect length, not correctly trimmed, and not inspected properly.
December 31, 2025Medical DevicesFDA
Cook Incorporated recalls Ring Transjugular Intrahepatic Access Sets, Reference Part Numbers: 1) RTPS-100; 2) RTPS-100-10.0; The Ring Trans
Hazard: Cook Medical identified that products supplied in the affected device lots may have been manufactured out of specification. Impacted products may have been cut to the incorrect length, not correctly trimmed, and not inspected properly.
December 31, 2025Medical DevicesFDA
Cook Incorporated recalls 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
Hazard: Cook Medical identified that products supplied in the affected device lots may have been manufactured out of specification. Impacted products may have been cut to the incorrect length, not correctly trimmed, and not inspected properly.
June 25, 2025Medical DevicesFDA
Cook Incorporated recalls Beacon Tip 5.0 Fr Angiographic catheters are designed to facilitate diagnostic and therapeutic procedures. Catheters are
Hazard: Cook Medical identified that catheters supplied in the affected device lots may experience tip separation.
May 28, 2025Medical DevicesFDA
Cook Incorporated recalls Check=Flo Performer Introducer, 14.0Fr, Reference Part Number(RPN) REF RCFW-14.0-0-38-30-RB, Order Number (GPN) REF G08
Hazard: Cook Medical identified that devices from the affected device lots may contain the incorrectly sized introducer sheath.
May 28, 2025Medical DevicesFDA
Cook Incorporated recalls Check=Flo Performer Introducer, 10.0Fr, Reference Part Number(RPN) REF RCFW-10.0-0-38-30-RB, Order Number (GPN) REF G08
Hazard: Cook Medical identified that devices from the affected device lots may contain the incorrectly sized introducer sheath.
May 21, 2025Medical DevicesFDA
Cook Incorporated recalls Tornado Embolization Microcoil, intended for embolization of selective vessel supply to arteriovenous malformations and
Hazard: Cook Medical identified that devices from the affected device lots may contain the incorrectly sized embolization coil.
November 27, 2024Medical DevicesFDA
Cook Incorporated recalls Approach CTO Micro Wire Guide, RPN CMW-14-190-25G, GPN G50789
Hazard: Devices from the affected device lots have labels that state the incorrect expiration dates.
November 20, 2024Medical DevicesFDA
Cook Incorporated recalls Approach Hydro ST Micro Wire Guide; Catalog prefix HMW Reference Part Numbers: HMW-14-135-ST HMW-14-190-ST HMW-14-
Hazard: Affected device lots have labels that state the incorrect expiration dates.