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Cook Incorporated

68 FDA 510(k) clearances · Recalling firm

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RecordFirmDate
Centimeter Sizing Catheter RPN N5.0-35-100-P-10S-PIG-CSC-20 GPN G11916 Catheters for use i recall (Z-1934-2026)Cook Incorporated2026-05-01
Aurous Centimeter Sizing Catheter RPN N5.0-35-100-P-10S-PIG-CSC-20-01 GPN G47308 Sizing ca recall (Z-1935-2026)Cook Incorporated2026-05-01
Beacon Tip Centimeter Sizing Catheter RPN/GPN NR5.0-35-70-P-10S-0-CSC-20 G31213 NR5.0-35-1 recall (Z-1936-2026)Cook Incorporated2026-05-01
COOK MEDICAL Approach CTO-6 Micro Wire Guide, Reference Part Number CMW-14-190-6G, Order N recall (Z-1775-2026)Cook Incorporated2026-04-06
COOK MEDICAL Approach CTO-12 Micro Wire Guide: Reference Part Number CMW-14-190-12G, Order recall (Z-1776-2026)Cook Incorporated2026-04-06
COOK MEDICAL Approach CTO-18 Micro Wire Guide, Reference Part Number CMW-14-190-18G, Order recall (Z-1777-2026)Cook Incorporated2026-04-06
COOK MEDICAL Arterial Pressure Monitoring Tray, Reference Part Number APMY-2.5-15-0-2.5 , recall (Z-1778-2026)Cook Incorporated2026-04-06
COOK MEDICAL Blue Rhino G2-Multi Percutaneous Tracheostomy Introducer Set: Reference Part recall (Z-1779-2026)Cook Incorporated2026-04-06
COOK MEDICAL Blue Rhino G2-Multi Percutaneous Tracheostomy Introducer Tray: Reference Part recall (Z-1780-2026)Cook Incorporated2026-04-06
COOK MEDICAL Ciaglia Blue Rhino Percutaneous Tracheostomy Introducer Set: Reference Part N recall (Z-1781-2026)Cook Incorporated2026-04-06
COOK MEDICAL Cook Staged Extubation Set: Reference Part Number C-CAE-14.0-83-EXTU, Order N recall (Z-1782-2026)Cook Incorporated2026-04-06
COOK MEDICAL Cook Spectrum Central Venous Catheter Tray: Reference Part Number C-UTLMY-701 recall (Z-1783-2026)Cook Incorporated2026-04-06
COOK MEDICAL Cook Strange Bile Duct Stone Exploration Set: Reference Part Number C-CSRC-7. recall (Z-1784-2026)Cook Incorporated2026-04-06
Melker Universal Cuffed Emergency Cricothyrotomy Catheter Set: Reference Part Number C-TCC recall (Z-1785-2026)Cook Incorporated2026-04-06
COOK MEDICAL Multipurpose Drainage Catheter: Reference Part Number ULT8.5-38-25-P-CLMS-8-R recall (Z-1786-2026)Cook Incorporated2026-04-06
COOK MEDICAL NCompass Nitinol Stone Extractor: Reference Part Number C-NTSE-2.4-115-NC3, O recall (Z-1787-2026)Cook Incorporated2026-04-06
COOK MEDICAL Spectrum Central Venous Catheter Set: Reference Part Number C-UDLM-401J-ABRM- recall (Z-1788-2026)Cook Incorporated2026-04-06
COOK MEDICAL Spectrum Central Venous Tray: Reference Part Number C-UQLMYJ-1001J-RSC-ABRM-H recall (Z-1789-2026)Cook Incorporated2026-04-06
COOK MEDICAL Thal-Quick Chest Tube Tray: Reference Part Number C-TQTSY-3200, Order Number recall (Z-1790-2026)Cook Incorporated2026-04-06
COOK MEDICAL Wayne Pneumothorax Set: Reference Part Number C-UTPT-1020-WAYNE-IMH, Order Nu recall (Z-1791-2026)Cook Incorporated2026-04-06
COOK MEDICAL Wayne Pneumothorax Tray: Reference Part Number C-UTPTY-1400-WAYNE-112497-IMH, recall (Z-1792-2026)Cook Incorporated2026-04-06
Flexor Check-Flo Introducers and Sets, Reference Part Numbers: 1) KCFW-9.0-18/38-45-RB-ANL recall (Z-0993-2026)Cook Incorporated2025-12-23
Ring Transjugular Intrahepatic Access Sets, Reference Part Numbers: 1) RTPS-100; 2) RTPS-1 recall (Z-0994-2026)Cook Incorporated2025-12-23
Rsch-Uchida Transjugular Liver Access Sets, Reference Part Numbers: RUPS-100; The Rsch-Uch recall (Z-0995-2026)Cook Incorporated2025-12-23
Beacon Tip 5.0 Fr Angiographic catheters are designed to facilitate diagnostic and therape recall (Z-1902-2025)Cook Incorporated2025-06-16
Check=Flo Performer Introducer, 10.0Fr, Reference Part Number(RPN) REF RCFW-10.0-0-38-30-R recall (Z-1786-2025)Cook Incorporated2025-05-16
Check=Flo Performer Introducer, 14.0Fr, Reference Part Number(RPN) REF RCFW-14.0-0-38-30-R recall (Z-1787-2025)Cook Incorporated2025-05-16
Tornado Embolization Microcoil, intended for embolization of selective vessel supply to ar recall (Z-1762-2025)Cook Incorporated2025-05-14
Approach CTO Micro Wire Guide, RPN CMW-14-190-25G, GPN G50789 recall (Z-0499-2025)Cook Incorporated2024-11-21
Approach CTO Micro Wire Guide, Guide Wire, Catalog Prefix CMW; Reference Part Numbers: CMW recall (Z-0346-2025)Cook Incorporated2024-11-08
Approach Hydro ST Micro Wire Guide; Catalog prefix HMW Reference Part Numbers: HMW-14-135- recall (Z-0347-2025)Cook Incorporated2024-11-08
Check-Flo Performer Introducer Set, Reference Part Number RCF-5.0-35-45-J, Order Number G2 recall (Z-0045-2025)Cook Incorporated2024-10-09
Ultrathane Mac-Loc Locking Loop Multipurpose Drainage Catheter ULT16.0-38-25-P-6S-MCL-HC-- recall (Z-2222-2024)Cook Incorporated2024-06-27
Ultrathane Cook-Cope Type Locking Loop Multipurpose Drainage Catheter-ULT12.0-38-45-P-6S-C recall (Z-2223-2024)Cook Incorporated2024-06-27
Chiba Biopsy Needle - Used for aspiration biopsy. REFERENCE PART NUMBER (RPN) ORDER NUMBER recall (Z-1525-2024)Cook Incorporated2024-04-12
Trocar Needle - Used for dilating puncture sites or catheter tracts for percutaneous place recall (Z-1526-2024)Cook Incorporated2024-04-12
Yueh Centesis Disposable Catheter Needle - Intended for use in percutaneous fluid aspirati recall (Z-1527-2024)Cook Incorporated2024-04-12
Peel-Away Introducer - Intended for the percutaneous introduction of balloon, electrode an recall (Z-1528-2024)Cook Incorporated2024-04-12
Entuit Secure Adjustable Gastrointestinal Suture Anchor Set - Intended for anchoring the a recall (Z-1529-2024)Cook Incorporated2024-04-12
Dilator - Intended to be used for dilating puncture sites or catheter tracts for percutane recall (Z-1530-2024)Cook Incorporated2024-04-12
Dilator With AQ Hydrophilic Coating - Intended to be used for dilating puncture sites or c recall (Z-1531-2024)Cook Incorporated2024-04-12
Dilator - Coons Taper - Used for dilating puncture sites or catheter tracts for percutaneo recall (Z-1532-2024)Cook Incorporated2024-04-12
Blue Rhino G2-Multi Percutaneous Tracheostomy Introducer Set, Reference Part Numbers C-PTI recall (Z-1427-2023)Cook Incorporated2023-05-10
Blue Rhino G2-Multi Percutaneous Tracheostomy Introducer Tray, Reference Part Numbers C-PT recall (Z-1428-2023)Cook Incorporated2023-05-10
Amplatz extra Stiff Wire Guide, Stiff Guidewire (OUS ONLY); Reference Part Number: THSF-35 recall (Z-1824-2022)Cook Incorporated2022-09-28
Bentson Plus Wire Guide (Extra Body/20cm Distal Flexibility with Softened Tip), Guidewire; recall (Z-1825-2022)Cook Incorporated2022-09-28
Bentson Wire Guide, Guidewire (OUS ONLY); Reference Part Number: TSMB-35-145 (GPN G27041) recall (Z-1826-2022)Cook Incorporated2022-09-28
Bentson Wire Guide (20cm Distal Flexibility with Softened Tip), Guidewire; Reference Part recall (Z-1827-2022)Cook Incorporated2022-09-28
Coons Interventional Wire Guide, Guidewire; Reference Part Number/GPN: THSF-35-145-COONS G recall (Z-1828-2022)Cook Incorporated2022-09-28
Cope Mandril Wire Guide (Nitinol), Nitinol Guidewire; Reference Part Number/GPN: PMG-18SP- recall (Z-1829-2022)Cook Incorporated2022-09-28
Cope Mandril Wire Guide (Stainless Steel), Stainless Steel Guidewire Reference Part Number recall (Z-1830-2022)Cook Incorporated2022-09-28
Double Flexible Tipped Wire Guide, Guidewire Reference Part Number/GPN TDOC-35-145-0-3 G00 recall (Z-1831-2022)Cook Incorporated2022-09-28
Fixed Core Wire Guide, Guidewire Reference Part Number/GPN THSCF-25-180-3 G02165 TSCF-25-8 recall (Z-1832-2022)Cook Incorporated2022-09-28
Fixed Core Wire Guide (Safe-T-J Curved), Guidewire Reference Part Number/GPN: TSCF-25-180- recall (Z-1833-2022)Cook Incorporated2022-09-28
Fixed Core Wire Guide (Straight), Guidewire Reference Part Number/GPN: C-SF-18-30 G02261 C recall (Z-1834-2022)Cook Incorporated2022-09-28
Heavy Double Flexible Tipped Wire Guide, Guidewire Reference Part Number/GPN: THDOC-35-60- recall (Z-1835-2022)Cook Incorporated2022-09-28
Newton Wire Guide (LT Taper/10cm Distal Flexibility), Guidewire Reference Part Number/GPN: recall (Z-1836-2022)Cook Incorporated2022-09-28
Roadrunner PC Hydrophilic Wire Guide, Hydrophilic Guidewire Reference Part Number/GPN: RPC recall (Z-1837-2022)Cook Incorporated2022-09-28
Roadrunner PC Wire Guide (Nimble), Guidewire Reference Part Number/GPN: RFSPC-35-145 G0960 recall (Z-1838-2022)Cook Incorporated2022-09-28
Roadrunner PC Wire Guide (Nimble Floppy), Guidewire RFPC-35-145 G07914 recall (Z-1839-2022)Cook Incorporated2022-09-28
Roadrunner PC Wire Guide (The Firm LT), Guidewire Reference Part Number/GPN RLPC-35-145 G0 recall (Z-1840-2022)Cook Incorporated2022-09-28
Roadrunner PC Wire Guide (The Firm), Guidewire Reference Part Number/GPN RPC-35-145 G06979 recall (Z-1841-2022)Cook Incorporated2022-09-28
Rosen Curved Wire Guide, Guidewire Reference Part Number/GPN THSCF-35-220-1.5-ROSEN G01623 recall (Z-1842-2022)Cook Incorporated2022-09-28
Torq-Flex Wire Guide Australian Modification, Guidewire Reference Part Number/GPN STF-18-4 recall (Z-1843-2022)Cook Incorporated2022-09-28
Vinyl Connecting Tube, Connecting Tube Reference Part Number/GPN CTU14.0-30-ST G02278 CTU1 recall (Z-1844-2022)Cook Incorporated2022-09-28
Lunderquist -Ring Torque Wire Guide, Guidewire Reference Part Number/GPN THSF-35-125-THG G recall (Z-1845-2022)Cook Incorporated2022-09-28
Movable Core Wire Guide (Tapered Tefcor) (OUS ONLY), Guidewire Reference Part Number/GPN T recall (Z-1846-2022)Cook Incorporated2022-09-28
Movable Core Wire Guide (Tefcor), Guidewire (OUS ONLY) Reference Part Number/GPN TMT-35-14 recall (Z-1847-2022)Cook Incorporated2022-09-28

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Every clearance here is in the API, with alerts when new ones post.