Cook Incorporated
Cook Incorporated holds FDA 510(k) medical device clearances, first cleared 2006, most recent 2024, with 85 FDA device recalls on record.
Top product codes for Cook Incorporated
FDA recalls by Cook Incorporated
10 most recent of 85- Z-1934-2026 — 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 variety of French sizes, endhole sizes, lengths, materials and designs (e.g., polyethylene or nylon, non-braided or braided with 1:1 torque). The choice of catheter material for different angiographic procedures should be based on the physician s experience.
- Z-1935-2026 — 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 gold marker bands. These catheters are for use in angiographic procedures and available in a variety of lengths (70 and 100 cm) and tip configurations (straight, PIG, and VCF).
- Z-1936-2026 — 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-CSC-20 G31216 NR5.0-35-70-P-10S-VCF-CSC-20 G31220 NR5.0-35-100-P-10S-VCF-CSC-20 G31221 Sizing catheters are single-use, sterile catheters with gold marker bands. These catheters are for use in angiographic procedures and available in a variety of lengths (70 and 100 cm) and tip configurations (straight, PIG, and VCF).
- Z-1778-2026 — COOK MEDICAL Arterial Pressure Monitoring Tray, Reference Part Number APMY-2.5-15-0-2.5 , Order Number G58412; Reference Part Number APMY-4.0-21J-1-12, Order Number G58419
- Z-1785-2026 — Melker Universal Cuffed Emergency Cricothyrotomy Catheter Set: Reference Part Number C-TCCSB-500-UNI, Order Number G32193; Reference Part Number C-TCCSB-500-UNI-01, Order Number G47665.
- Z-1784-2026 — COOK MEDICAL Cook¿ Strange Bile Duct Stone Exploration Set: Reference Part Number C-CSRC-7.5D-40-STRANGE, Order Number G09108
- Z-1791-2026 — COOK MEDICAL Wayne Pneumothorax Set: Reference Part Number C-UTPT-1020-WAYNE-IMH, Order Number G56532; Reference Part Number C-UTPT-1400-WAYNE-112497-IMH, Order Number G56535.
- Z-1780-2026 — COOK MEDICAL Blue Rhino¿ G2-Multi Percutaneous Tracheostomy Introducer Tray: Reference Part Number C-PTISY-100-HC-G-NA, Order Number G57703; Reference Part Number C-PTISY-100-UNL-HC-G-NA, Order Number G57706; Reference Part Number C-PTISY-100-UNS-HC-G-NA, Order Number G57704.
- Z-1777-2026 — COOK MEDICAL Approach CTO-18 Micro Wire Guide, Reference Part Number CMW-14-190-18G, Order Number G50788; Reference Part Number CMW-14-300-18G, Order Number G50792
- Z-1789-2026 — COOK MEDICAL Spectrum¿ Central Venous Tray: Reference Part Number C-UQLMYJ-1001J-RSC-ABRM-HC-FST-A-RD, Order Number G44800; Reference Part Number C-UTLMYJ-701J-ABRM-HC-IHI-FST-A-RD, Order Number G44809; Reference Part Number C-UTLMYJ-701J-RSC-ABRM-HC-FST-A-RD, Order Number G44806; Reference Part Number C-UTLMYJ-701J-RSC-ABRM-HC-IHI-FST-A-RD, Order Number G44807.
Recalls are matched by FDA's recalling-firm name — openFDA's enforcement dataset doesn't reference 510(k) numbers, so a recall here may cover devices beyond this company's 510(k) clearances.
Recent clearances by Cook Incorporated
1–100 of 175- K233177 — Nest VT Vitrification Device
- K222254 — Gunther Tulip Vena Cava Filter Retrieval Set
- K223098 — Bakri Essential Postpartum Balloon
- K210734 — Endovascular Dilator and Sets
- K203670 — Extra Large Check-Flo Introducer
- K191498 — Cook-Cope Loop Nephrostomy Set, Ultrathane Nephrostomy Set with Mac-Loc, Ultrathane Suprapubic Set with Mac-Loc
- K190903 — Lawson Retrograde Nephrostomy Wire Puncture Set
- K191163 — Lumax Guiding Catheter
- K193133 — Blue Rhino G1-Multi Percutaneous Tracheostomy Introducer Set, Blue Rhino G1-Multi Percutaneous Tracheostomy Introducer Tray, Blue Rhino G2-Multi Percutaneous Tracheostomy Introducer Set, Blue Rhino G2-Multi Percutaneous Tracheostomy Introducer Tray, Weinmann-Multi Percutaneous Tracheostomy Exchange Set
- K190084 — McLean-Ring Enteral Feeding Tube Set
- K183323 — UPJ Occlusion Balloon Catheter
- K182985 — Roadrunner PC Wire Guide, Olcott Torque Device
- K183051 — Kaye Nephrostomy Tamponade Balloon Catheter and Stent Set
- K182832 — Cope Pediatric Gastrointestinal Suture Anchor Set, Enterostomy Suture Anchor Set
- K191485 — Deflectable Brush Biopsy Set
- K182695 — Pigtail Ureteral Catheter Set, Sof-Flex AQ Coated Pigtail Ureteral Catheter
- K182403 — Peel-Away Introducer
- K182252 — Cook Unimpregnated Central Venous Catheter
- K183035 — Percutaneous Entry Set, Skinny Needle(R) with Chiba Tip, Disposable Two-part Trocar Needle
- K191015 — Soft-Pass Embryo Mock Transfer Catheter Sets (Soft-Pass Embryo Mock Transfer Catheter Set and Soft-Pass Embryo Mock Transfer Catheter Set with Echogenic Tip)
- K182231 — Brush Biopsy Set; Deflectable Brush Biopsy Set
- K182071 — Multi-Sideport Catheter Infusion Set
- K181971 — Bander Ureteral Diversion Stent Set, Dretler Ureteroscopy Stent Set
- K182399 — Park Blade Septostomy Catheter
- K181770 — Intrauterine Access Balloon Catheter, Selective Salpingography Catheter
- K181735 — Percutaneous Neonatal Pigtail Nephrostomy Set, Pediatric Nephrostomy Stent Set
- K181722 — Polyethylene Catheter
- K181353 — Lunderquist® Fixed Core Wire Guide
- K181097 — Cook Cystostomy Catheter Set
- K183467 — Roadrunner Extra Support Wire Guide
- K182709 — One-Step Suprapubic Introducer
- K180830 — Reuter Tip Deflecting Wire Guide
- K183036 — Dilator Sets
- K180846 — Arterial Pressure Monitoring Set/Tray
- DEN170055 — Retrograde Intubation Set
- K180792 — Arterial Pressure Monitoring Set/Tray
- K180557 — Greene Renal Transplant Stent Set
- K181757 — Günther Tulip® Vena Cava Filter Retrieval Set
- K182066 — O'Brien Suprapubic Introducer Set, Cook SP Tube Introducer Set
- K180286 — Polyethylene Catheter
- K180291 — Cook Silicone Balloon HSG Catheter
- K180300 — Margolin HSG Cannula, Goldstein Sonohysterography Catheter
- K180302 — Guardia Access Malleable Obturator, Guardia Obturator, Soft-Pass Obturator, Soft-Trans Malleable Obturator, Guardia ETS Embryo-Tested Syringe, Flushing Catheter
- K180054 — Royal Flush Plus High-Flow Catheter
- K180216 — Seidmon Antegrade AQ Stent Set
- K180029 — Malecot Nephrostomy Catheter/Stent Set
- K180182 — Dual Lumen Ureteral Access Catheter, Flexi-Tip Dual Lumen Ureteral Access Catheter
- K180053 — Sof-Flex Ureteral Stent Set
- K173657 — Radiance(TM) Clear Sharklet(R) Silicone Foley Catheter
- K181713 — Ultraxx Nephrostomy Balloon Catheter Set
- K181431 — Laser Ureteral Catheter
- K181712 — San Antonio Stopcock
- K171272 — Cook-Swartz Doppler Flow Probe
- K173654 — Ureteral Dilator Sets, Ureteral Dilators
- K180552 — Modified Novy Cornual Cannulation Set
- K181144 — Angled Tip Ureteral Catheter
- K173414 — Advance Biliary Balloon Catheter
- K181351 — Double Flexible Tipped Wire Guides
- K173155 — Pakter Curved Needle Set
- K171609 — Check-Flo Performer Introducer Micropuncture Radial Artery Access Set
- K180756 — Safety Wire Guide Introducer
- K180034 — Weinmann Tracheostomy Exchange Set
- K172980 — Micropuncture Pedal Access Set
- K180028 — Cook 810 Set, Desilets-Hoffman Introducer Set
- K173035 — Gordon Large-Bore Curved Drainage Catheter, Nephrostomy Pigtail Drainage Catheter, Percutaneous Nephrostomy Set, Pigtail Drainage Catheter Needle Set, Multipurpose Drainage Catheters and Sets
- K171917 — Frova Intubating Introducer
- K172588 — Balloon Catheter and Balloon Ureteral Dilator Set
- K171603 — Cope Nephroureterostomy Stent and Amplatz Ureteral Stent Set
- K173103 — Pivet and Soft-Pass Embryo Transfer Catheter Sets
- K173686 — Guardia Access Embryo Transfer Catheter Sets and Sydney IVF® Transfer Catheter
- K172635 — High-Flo Silver Polyethylene Catheter
- K171988 — Performer Guiding Sheath
- K171997 — Mandril Wire Guide
- K172017 — Black Silicone Filiform Double Pigtail Stent Set
- K173105 — Endoscopic Cap, Check-Flo Adapter, Side-arm Adapter, Tuohy-Borst Adapter
- K171912 — Double Flexible Tip Wire Guides
- K171764 — Fixed Core Wire Guides
- K171820 — Transjugular Liver Access Sets
- K171810 — Cone Tip Ureteral Catheter, Rutner Universal Wedge Catheter
- K171915 — Nathanson Transcystic Bile Duct Stone Exploration Pack
- K171601 — Ultraxx Nephrostomy Balloon Catheter
- K171994 — Silicone Peripherally Inserted Central Venous Catheter Set/Tray
- K171600 — Renal Access Cobra Catheter, Kumpe Access Catheter
- K171604 — Rösch Thurmond Fallopian Tube Catheterization Set, Fallopian Tube Catheterization Set, and Fallopian Tube Catheterization Wire Guide with Platinum Tip
- K171662 — Open-End Ureteral Catheter, Open-End Ureteral Catheter Sof-Flex, EchoTip Open-End Ureteral Catheter, Open-End Flexi-Tip Ureteral Catheter, Flexi-Tip Ureteral Catheter (Closed End), Whistle Tip Ureteral Catheter, Round Tip Ureteral Catheter, Spiral Tip Ureteral Access Catheter, Pediatric Ureteral Catheter
- K171264 — Royal Flush Catheter
- K171445 — Amplatz Support Wire Guide with Apex Curve
- K172051 — Guardia Access Nano and Soft-Trans Embryo Transfer Catheter Sets, Soft-Trans Embryo Transfer Catheter, Soft-Trans Guide Catheter
- K171948 — Roadrunner Extra Support Wire Guide
- K172321 — Shepard, Insemi-Cath, and Soft-Pass Coaxial - Cook Intrauterine Insemination Catheters
- K171275 — Micropuncture Introducer Set, Micropuncture Introducer Set with Push-Plus Design, Micropuncture Introducer Set with Silhouette Transitionless Design, Micropuncture Introducer Set with Silhouette Transitionless Design and Push-Plus Design
- K173685 — Peel-Away Introducer Set
- K173687 — Strange Bile Duct Stone Exploration Set
- K172217 — Flexor Ureteral Access Sheath and Flexor Parallel Rapid Release Ureteral Access Sheath
- K170898 — Wittich Nitinol Stone Basket
- K172278 — Firlit-Kluge Urethral Stent, Koyle Diaper Stent, Zaontz Urethral Stent
- K173068 — Performer Introducer
- K173355 — Gastric Sizing Balloon Catheter
- K173289 — Beacon Tip Torcon NB Advantage Catheter, Slip-Cath Beacon Tip Catheter and Shuttle Select Slip-Cath Catheter, Beacon Tip Centimeter Sizing Catheter, Beacon Tip Cava Vessel Sizing Catheter, Beacon Tip White Vessel Sizing Catheter
- K170931 — CXI TriForce Peripheral Crossing Set
Data sourced from openFDA. This site is unofficial and independent of the FDA.