Cook Incorporated

FDA Regulatory Profile

Summary

Total Recalls
64 (3 Class I)
510(k) Clearances
175
Inspections
13
Compliance Actions
1

Recent Recalls

NumberClassProductDate
Z-0993-2026Class IIFlexor Check-Flo Introducers and Sets, Reference Part Numbers: 1) KCFW-9.0-18/38-45-RB-ANL0-HC; November 26, 2025
Z-0994-2026Class IIRing Transjugular Intrahepatic Access Sets, Reference Part Numbers: 1) RTPS-100; 2) RTPS-100-10November 26, 2025
Z-0995-2026Class IIR¿sch-Uchida Transjugular Liver Access Sets, Reference Part Numbers: RUPS-100; The R¿sch-Uchida TNovember 26, 2025
Z-1902-2025Class IBeacon Tip 5.0 Fr Angiographic catheters are designed to facilitate diagnostic and therapeutic proceMay 15, 2025
Z-1786-2025Class IICheck=Flo Performer Introducer, 10.0Fr, Reference Part Number(RPN) REF RCFW-10.0-0-38-30-RB, Order April 17, 2025
Z-1787-2025Class IICheck=Flo Performer Introducer, 14.0Fr, Reference Part Number(RPN) REF RCFW-14.0-0-38-30-RB, Order April 17, 2025
Z-1762-2025Class IITornado Embolization Microcoil, intended for embolization of selective vessel supply to arteriovenouApril 17, 2025
Z-0499-2025Class IIApproach CTO Micro Wire Guide, RPN CMW-14-190-25G, GPN G50789October 14, 2024
Z-0346-2025Class IIApproach CTO Micro Wire Guide, Guide Wire, Catalog Prefix CMW; Reference Part Numbers: CMW-14-19October 8, 2024
Z-0347-2025Class IIApproach Hydro ST Micro Wire Guide; Catalog prefix HMW Reference Part Numbers: HMW-14-135-ST HMOctober 8, 2024
Z-0045-2025Class IICheck-Flo Performer Introducer Set, Reference Part Number RCF-5.0-35-45-J, Order Number G27242. PerfSeptember 16, 2024
Z-2223-2024Class IIUltrathane Cook-Cope Type Locking Loop Multipurpose Drainage Catheter-ULT12.0-38-45-P-6S-CLM-RH-ntenMay 15, 2024
Z-2222-2024Class IIUltrathane Mac-Loc Locking Loop Multipurpose Drainage Catheter ULT16.0-38-25-P-6S-MCL-HC--Intended fMay 15, 2024
Z-1529-2024Class IIEntuit Secure Adjustable Gastrointestinal Suture Anchor Set - Intended for anchoring the anterior waMarch 1, 2024
Z-1530-2024Class IIDilator - Intended to be used for dilating puncture sites or catheter tracts for percutaneous placemMarch 1, 2024
Z-1525-2024Class IIChiba Biopsy Needle - Used for aspiration biopsy. REFERENCE PART NUMBER (RPN) ORDER NUMBER (GPN):March 1, 2024
Z-1532-2024Class IIDilator - Coons Taper - Used for dilating puncture sites or catheter tracts for percutaneous placemeMarch 1, 2024
Z-1526-2024Class IITrocar Needle - Used for dilating puncture sites or catheter tracts for percutaneous placement of deMarch 1, 2024
Z-1527-2024Class IIYueh Centesis Disposable Catheter Needle - Intended for use in percutaneous fluid aspirations, such March 1, 2024
Z-1531-2024Class IIDilator With AQ Hydrophilic Coating - Intended to be used for dilating puncture sites or catheter trMarch 1, 2024

Recent 510(k) Clearances

K-NumberDeviceDate
K233177Nest VT Vitrification DeviceMarch 8, 2024
K222254Gunther Tulip Vena Cava Filter Retrieval SetMay 16, 2023
K223098Bakri Essential Postpartum BalloonOctober 28, 2022
K210734Endovascular Dilator and SetsApril 6, 2021
K203670Extra Large Check-Flo IntroducerFebruary 16, 2021
K191498Cook-Cope Loop Nephrostomy Set, Ultrathane Nephrostomy Set with Mac-Loc, Ultrathane Suprapubic Set wJanuary 29, 2020
K190903Lawson Retrograde Nephrostomy Wire Puncture SetDecember 16, 2019
K193133Blue Rhino G1-Multi Percutaneous Tracheostomy Introducer Set, Blue Rhino G1-Multi Percutaneous TrachDecember 12, 2019
K191163Lumax Guiding CatheterDecember 12, 2019
K190084McLean-Ring Enteral Feeding Tube SetOctober 11, 2019
K183323UPJ Occlusion Balloon CatheterAugust 5, 2019
K182985Roadrunner PC Wire Guide, Olcott Torque DeviceJuly 22, 2019
K183051Kaye Nephrostomy Tamponade Balloon Catheter and Stent SetJuly 16, 2019
K191485Deflectable Brush Biopsy SetJune 26, 2019
K182832Cope Pediatric Gastrointestinal Suture Anchor Set, Enterostomy Suture Anchor SetJune 26, 2019
K182695Pigtail Ureteral Catheter Set, Sof-Flex AQ Coated Pigtail Ureteral CatheterJune 17, 2019
K182403Peel-Away IntroducerMay 29, 2019
K191015Soft-Pass Embryo Mock Transfer Catheter Sets (Soft-Pass Embryo Mock Transfer Catheter Set and Soft-PMay 17, 2019
K182252Cook Unimpregnated Central Venous CatheterMay 17, 2019
K183035Percutaneous Entry Set, Skinny Needle(R) with Chiba Tip, Disposable Two-part Trocar NeedleMay 17, 2019