Cook Incorporated
FDA Regulatory Profile
Cook Incorporated appears in FDA public data with 85 recalls — including 6 Class I (most serious) —, 175 510(k) clearances, 14 FDA inspections, and 1 compliance action on record. Its most recent recall (Z-1934-2026, Class I) was initiated on April 2, 2026. Its most recent 510(k) clearance was granted on March 8, 2024.
Summary
- Total Recalls
- 85 (6 Class I)
- 510(k) Clearances
- 175
- Inspections
- 14
- Compliance Actions
- 1
Recent Recalls
| Number | Class | Product | Date |
|---|
| Z-1934-2026 | Class I | Centimeter Sizing Catheter RPN N5.0-35-100-P-10S-PIG-CSC-20 GPN G11916 Catheters for use in ang | April 2, 2026 |
| Z-1936-2026 | Class I | Beacon Tip Centimeter Sizing Catheter RPN/GPN NR5.0-35-70-P-10S-0-CSC-20 G31213 NR5.0-35-100-P-1 | April 2, 2026 |
| Z-1935-2026 | Class I | Aurous Centimeter Sizing Catheter RPN N5.0-35-100-P-10S-PIG-CSC-20-01 GPN G47308 Sizing cathete | April 2, 2026 |
| Z-1783-2026 | Class II | COOK MEDICAL Cook¿ Spectrum¿ Central Venous Catheter Tray: Reference Part Number C-UTLMY-701J-ABRM- | March 5, 2026 |
| Z-1787-2026 | Class II | COOK MEDICAL NCompass¿ Nitinol Stone Extractor: Reference Part Number C-NTSE-2.4-115-NC3, Order Num | March 5, 2026 |
| Z-1782-2026 | Class II | COOK MEDICAL Cook Staged Extubation Set: Reference Part Number C-CAE-14.0-83-EXTU, Order Number G24 | March 5, 2026 |
| Z-1788-2026 | Class II | COOK MEDICAL Spectrum¿ Central Venous Catheter Set: Reference Part Number C-UDLM-401J-ABRM-HC, Orde | March 5, 2026 |
| Z-1775-2026 | Class II | COOK MEDICAL Approach CTO-6 Micro Wire Guide, Reference Part Number CMW-14-190-6G, Order Number G507 | March 5, 2026 |
| Z-1789-2026 | Class II | COOK MEDICAL Spectrum¿ Central Venous Tray: Reference Part Number C-UQLMYJ-1001J-RSC-ABRM-HC-FST-A- | March 5, 2026 |
| Z-1779-2026 | Class II | COOK MEDICAL Blue Rhino G2-Multi Percutaneous Tracheostomy Introducer Set: Reference Part Number C- | March 5, 2026 |
| Z-1778-2026 | Class II | COOK MEDICAL Arterial Pressure Monitoring Tray, Reference Part Number APMY-2.5-15-0-2.5 , Order Numb | March 5, 2026 |
| Z-1776-2026 | Class II | COOK MEDICAL Approach CTO-12 Micro Wire Guide: Reference Part Number CMW-14-190-12G, Order Number | March 5, 2026 |
| Z-1792-2026 | Class II | COOK MEDICAL Wayne Pneumothorax Tray: Reference Part Number C-UTPTY-1400-WAYNE-112497-IMH, Order Nu | March 5, 2026 |
| Z-1777-2026 | Class II | COOK MEDICAL Approach CTO-18 Micro Wire Guide, Reference Part Number CMW-14-190-18G, Order Number G5 | March 5, 2026 |
| Z-1781-2026 | Class II | COOK MEDICAL Ciaglia Blue Rhino Percutaneous Tracheostomy Introducer Set: Reference Part Number C-P | March 5, 2026 |
| Z-1785-2026 | Class II | Melker Universal Cuffed Emergency Cricothyrotomy Catheter Set: Reference Part Number C-TCCSB-500-UN | March 5, 2026 |
| Z-1784-2026 | Class II | COOK MEDICAL Cook¿ Strange Bile Duct Stone Exploration Set: Reference Part Number C-CSRC-7.5D-40-ST | March 5, 2026 |
| Z-1790-2026 | Class II | COOK MEDICAL Thal-Quick Chest Tube Tray: Reference Part Number C-TQTSY-3200, Order Number G07242 | March 5, 2026 |
| Z-1780-2026 | Class II | COOK MEDICAL Blue Rhino¿ G2-Multi Percutaneous Tracheostomy Introducer Tray: Reference Part Number | March 5, 2026 |
| Z-1791-2026 | Class II | COOK MEDICAL Wayne Pneumothorax Set: Reference Part Number C-UTPT-1020-WAYNE-IMH, Order Number G565 | March 5, 2026 |
Recent 510(k) Clearances
| K-Number | Device | Date |
|---|
| K233177 | Nest VT Vitrification Device | March 8, 2024 |
| K222254 | Gunther Tulip Vena Cava Filter Retrieval Set | May 16, 2023 |
| K223098 | Bakri Essential Postpartum Balloon | October 28, 2022 |
| K210734 | Endovascular Dilator and Sets | April 6, 2021 |
| K203670 | Extra Large Check-Flo Introducer | February 16, 2021 |
| K191498 | Cook-Cope Loop Nephrostomy Set, Ultrathane Nephrostomy Set with Mac-Loc, Ultrathane Suprapubic Set w | January 29, 2020 |
| K190903 | Lawson Retrograde Nephrostomy Wire Puncture Set | December 16, 2019 |
| K191163 | Lumax Guiding Catheter | December 12, 2019 |
| K193133 | Blue Rhino G1-Multi Percutaneous Tracheostomy Introducer Set, Blue Rhino G1-Multi Percutaneous Trach | December 12, 2019 |
| K190084 | McLean-Ring Enteral Feeding Tube Set | October 11, 2019 |
| K183323 | UPJ Occlusion Balloon Catheter | August 5, 2019 |
| K182985 | Roadrunner PC Wire Guide, Olcott Torque Device | July 22, 2019 |
| K183051 | Kaye Nephrostomy Tamponade Balloon Catheter and Stent Set | July 16, 2019 |
| K182832 | Cope Pediatric Gastrointestinal Suture Anchor Set, Enterostomy Suture Anchor Set | June 26, 2019 |
| K191485 | Deflectable Brush Biopsy Set | June 26, 2019 |
| K182695 | Pigtail Ureteral Catheter Set, Sof-Flex AQ Coated Pigtail Ureteral Catheter | June 17, 2019 |
| K182403 | Peel-Away Introducer | May 29, 2019 |
| K183035 | Percutaneous Entry Set, Skinny Needle(R) with Chiba Tip, Disposable Two-part Trocar Needle | May 17, 2019 |
| K191015 | Soft-Pass Embryo Mock Transfer Catheter Sets (Soft-Pass Embryo Mock Transfer Catheter Set and Soft-P | May 17, 2019 |
| K182252 | Cook Unimpregnated Central Venous Catheter | May 17, 2019 |