Class 2 Device Recall Cook Medical Flexor Check Flo

• Date Initiated by Firm: November 26, 2025
• Date Posted: December 23, 2025
• Recall Status: Open, Classified
• Recall Number: Z-0993-2026
• Recall Event ID: 98027
• 510(K)Number: K142829
• Product Classification: Introducer, catheter - Product Code DYB
• Product: Flexor Check-Flo Introducers and Sets, Reference Part Numbers: 1) KCFW-9.0-18/38-45-RB-ANL0-HC; 2) KCFW-9.0-18/38-45-RB-ANL1-HC; 3) KCFW-10.0-35-45-RB-HFANL0-HC; 4) KCFW-10.0-35-45-RB-HFANL1-HC; 5) KCFW-12.0-35-45-RB-HFANL0-HC; 6) KCFW-12.0-35-45-RB-HFANL1-HC; 7) KCFW-9.0-35-38.5-RB-RTPS-100; 8) KCFW-10.0-35-RB-RTPS-100; 9) KCFW-9.0-38-55-RB-RAABE; 10) KCFW-9.0-38-70-RB-RAABE; 11) KCFW-9.0-38-80-RB; 12) KCFW-10.0-38-30-RB; 13) KCFW-10.0-38-40-RB; 14) KCFW-10.0-38-80-RB; 15) KCFW-10.0-38-RB; 16) KCFW-12.0-38-40-RB; 17) KCFW-12.0-38-80-RB; Flexor Introducers and Guiding Sheaths are designed to perform as a guiding sheath and/or introducer sheath. Flexor Introducers and Guiding Sheaths incorporate a Flexor shaft with a hemostasis valve and are provided with one or more dilators. These devices are available in various sizes, lengths and configurations. Configurations include differences in shaft construction, such as varying shaft stiffness and distal tip material and shape, dilator material, hydrophilic coating and/or distal radiopaque markers.
• Code Information: Reference Part Number (RPN)KCFW-9.0-18/38-45-RB-ANL0-HC: Order Number G49101, UDI (01)00827002491014(17)280708(10)16683401, Lot Number 16683401; Reference Part Number (RPN)KCFW-9.0-18/38-45-RB-ANL1-HC: Order Number G49102, UDI (01)00827002491021(17)280709(10)16685978, Lot Number 16685978; Reference Part Number (RPN)KCFW-9.0-18/38-45-RB-ANL1-HC: Order Number G49102, UDI (01)00827002491021(17)280804(10)NS16724225, Lot Number NS16724225; Reference Part Number (RPN)KCFW-9.0-18/38-45-RB-ANL1-HC: Order Number G49102, UDI (01)00827002491021(17)280808(10)NS16733075, Lot Number NS16733075; Reference Part Number (RPN)KCFW-10.0-35-45-RB-HFANL0-HC: Order Number G56278, UDI (01)00827002562783(17)280619(10)16652188, Lot Number 16652188; Reference Part Number (RPN)KCFW-10.0-35-45-RB-HFANL0-HC: Order Number G56278, UDI (01)00827002562783(17)280620(10)16653824, Lot Number 16653824; Reference Part Number (RPN)KCFW-10.0-35-45-RB-HFANL0-HC: Order Number G56278, UDI (01)00827002562783(17)280626(10)16662713, Lot Number 16662713; Reference Part Number (RPN)KCFW-10.0-35-45-RB-HFANL0-HC: Order Number G56278, UDI (01)00827002562783(17)280626(10)16662715, Lot Number 16662715; Reference Part Number (RPN)KCFW-10.0-35-45-RB-HFANL0-HC: Order Number G56278, UDI (01)00827002562783(17)280701(10)16675034, Lot Number 16675034; Reference Part Number (RPN)KCFW-10.0-35-45-RB-HFANL0-HC: Order Number G56278, UDI (01)00827002562783(17)280716(10)16696277, Lot Number 16696277; Reference Part Number (RPN)KCFW-10.0-35-45-RB-HFANL0-HC: Order Number G56278, UDI (01)00827002562783(17)280721(10)16703198, Lot Number 16703198; Reference Part Number (RPN)KCFW-10.0-35-45-RB-HFANL0-HC: Order Number G56278, UDI (01)00827002562783(17)280722(10)16704975, Lot Number 16704975; Reference Part Number (RPN)KCFW-10.0-35-45-RB-HFANL0-HC: Order Number G56278, UDI (01)00827002562783(17)280724(10)16709796, Lot Number 16709796; Reference Part Number (RPN)KCFW-10.0-35-45-RB-HFANL0-HC: Order Number G56278, UDI (01)00827002562783(17)280731(10)16720389, Lot Number 16720389; Reference Part Number (RPN)KCFW-10.0-35-45-RB-HFANL0-HC: Order Number G56278, UDI (01)00827002562783(17)280617(10)16647121, Lot Number 16647121; Reference Part Number (RPN)KCFW-10.0-35-45-RB-HFANL1-HC: Order Number G47700, UDI (01)00827002477001(17)280723(10)16707723, Lot Number 16707723; Reference Part Number (RPN)KCFW-10.0-35-45-RB-HFANL1-HC: Order Number G47700, UDI (01)00827002477001(17)280806(10)16727474, Lot Number 16727474; Reference Part Number (RPN)KCFW-10.0-35-45-RB-HFANL1-HC: Order Number G47700, UDI (01)00827002477001(17)280604(10)16629368, Lot Number 16629368; Reference Part Number (RPN)KCFW-10.0-35-45-RB-HFANL1-HC: Order Number G47700, UDI (01)00827002477001(17)280627(10)16664784, Lot Number 16664784; Reference Part Number (RPN)KCFW-12.0-35-45-RB-HFANL0-HC: Order Number G56279, UDI (01)00827002562790(17)280714(10)NS16692276, Lot Number NS16692276; Reference Part Number (RPN)KCFW-12.0-35-45-RB-HFANL0-HC: Order Number G56279, UDI (01)00827002562790(17)280610(10)16637317, Lot Number 16637317; Reference Part Number (RPN)KCFW-12.0-35-45-RB-HFANL0-HC: Order Number G56279, UDI (01)00827002562790(17)280618(10)16649121, Lot Number 16649121; Reference Part Number (RPN)KCFW-12.0-35-45-RB-HFANL0-HC: Order Number G56279, UDI (01)00827002562790(17)280729(10)16716240, Lot Number 16716240; Reference Part Number (RPN)KCFW-12.0-35-45-RB-HFANL0-HC: Order Number G56279, UDI (01)00827002562790(17)280523(10)16614648, Lot Number 16614648; Reference Part Number (RPN)KCFW-12.0-35-45-RB-HFANL0-HC: Order Number G56279, UDI (01)00827002562790(17)280611(10)16638978, Lot Number 16638978; Reference Part Number (RPN)KCFW-12.0-35-45-RB-HFANL1-HC: Order Number G47701, UDI (01)00827002477018(17)280717(10)16699013, Lot Number 16699013; Reference Part Number (RPN)KCFW-12.0-35-45-RB-HFANL1-HC: Order Number G47701, UDI (01)00827002477018(17)280527(10)16616270, Lot Number 16616270; Reference Part Number (RPN)KCFW-12.0-35-45-RB-HFANL1-HC: Order Number G47701, UDI (01)00827002477018(17)280609(10)16635801, Lot Number 16635801; Reference Part Number (RPN)KCFW-12.0-35-45-RB-HFANL1-HC: Order Number G47701, UDI (01)00827002477018(17)280620(10)16653825, Lot Number 16653825; Reference Part Number (RPN)KCFW-12.0-35-45-RB-HFANL1-HC: Order Number G47701, UDI (01)00827002477018(17)280627(10)16664786, Lot Number 16664786; Reference Part Number (RPN)KCFW-12.0-35-45-RB-HFANL1-HC: Order Number G47701, UDI (01)00827002477018(17)280702(10)16677072, Lot Number 16677072; Reference Part Number (RPN)KCFW-12.0-35-45-RB-HFANL1-HC: Order Number G47701, UDI (01)00827002477018(17)280728(10)16712983, Lot Number 16712983; Reference Part Number (RPN)KCFW-12.0-35-45-RB-HFANL1-HC: Order Number G47701, UDI (01)00827002477018(17)280728(10)16712985, Lot Number 16712985; Reference Part Number (RPN)KCFW-12.0-35-45-RB-HFANL1-HC: Order Number G47701, UDI (01)00827002477018(17)280731(10)16720393, Lot Number 16720393; Reference Part Number (RPN)KCFW-12.0-35-45-RB-HFANL1-HC: Order Number G47701, UDI (01)00827002477018(17)280813(10)16739603, Lot Number 16739603; Reference Part Number (RPN)KCFW-12.0-35-45-RB-HFANL1-HC: Order Number G47701, UDI (01)00827002477018(17)280520(10)16607958, Lot Number 16607958; Reference Part Number (RPN)KCFW-12.0-35-45-RB-HFANL1-HC: Order Number G47701, UDI (01)00827002477018(17)280605(10)16632678, Lot Number 16632678; Reference Part Number (RPN)KCFW-12.0-35-45-RB-HFANL1-HC: Order Number G47701, UDI (01)00827002477018(17)280702(10)16677073, Lot Number 16677073; Reference Part Number (RPN)KCFW-12.0-35-45-RB-HFANL1-HC: Order Number G47701, UDI (01)00827002477018(17)280711(10)16690408, Lot Number 16690408; Reference Part Number (RPN)KCFW-9.0-35-38.5-RB-RTPS-100: Order Number G13160, UDI (01)00827002131606(17)280721(10)NS16703184, Lot Number NS16703184; Reference Part Number (RPN)KCFW-9.0-35-38.5-RB-RTPS-101: Order Number G13160, UDI (01)00827002131606(17)280723(10)16707656, Lot Number 16707656; Reference Part Number (RPN)KCFW-9.0-35-38.5-RB-RTPS-102: Order Number G13160, UDI (01)00827002131606(17)280609(10)16635746, Lot Number 16635746; Reference Part Number (RPN)KCFW-10.0-35-RB-RTPS-100: Order Number G13081, UDI (01)00827002130814(17)280612(10)16641423, Lot Number 16641423; Reference Part Number (RPN)KCFW-10.0-35-RB-RTPS-100: Order Number G13081, UDI (01)00827002130814(17)280618(10)16649110, Lot Number 16649110; Reference Part Number (RPN)KCFW-9.0-38-55-RB-RAABE: Order Number G36393, UDI (01)00827002363939(17)280520(10)16607912, Lot Number 16607912; Reference Part Number (RPN)KCFW-9.0-38-70-RB-RAABE: Order Number G12606, UDI (01)00827002126060(17)280711(10)16690398, Lot Number 16690398; Reference Part Number (RPN)KCFW-9.0-38-70-RB-RAABE: Order Number G12606, UDI (01)00827002126060(17)280721(10)16703171, Lot Number 16703171; Reference Part Number (RPN)KCFW-9.0-38-70-RB-RAABE: Order Number G12606, UDI (01)00827002126060(17)280529(10)16621284, Lot Number 16621284; Reference Part Number (RPN)KCFW-9.0-38-70-RB-RAABE: Order Number G12606, UDI (01)00827002126060(17)280620(10)16653803, Lot Number 16653803; Reference Part Number (RPN)KCFW-9.0-38-70-RB-RAABE: Order Number G12606, UDI (01)00827002126060(17)280523(10)16614610, Lot Number 16614610; Reference Part Number (RPN)KCFW-9.0-38-80-RB: Order Number G09442, UDI (01)00827002094420(17)280723(10)NS16707657, Lot Number NS16707657; Reference Part Number (RPN)KCFW-9.0-38-80-RB: Order Number G09442, UDI (01)00827002094420(17)280515(10)NS16602824, Lot Number NS16602824; Reference Part Number (RPN)KCFW-9.0-38-80-RB: Order Number G09442, UDI (01)00827002094420(17)280609(10)NS16635753, Lot Number NS16635753; Reference Part Number (RPN)KCFW-9.0-38-80-RB: Order Number G09442, UDI (01)00827002094420(17)280611(10)NS16638955, Lot Number NS16638955; Reference Part Number (RPN)KCFW-10.0-38-30-RB: Order Number G13032, UDI (01)00827002130326(17)280729(10)16716200, Lot Number 16716200; Reference Part Number (RPN)KCFW-10.0-38-40-RB: Order Number G32233, UDI (01)00827002322332(17)280520(10)16607936, Lot Number 16607936; Reference Part Number (RPN)KCFW-10.0-38-40-RB: Order Number G32233, UDI (01)00827002322332(17)280611(10)16638956, Lot Number 16638956; Reference Part Number (RPN)KCFW-10.0-38-40-RB: Order Number G32233, UDI (01)00827002322332(17)280610(10)16637278, Lot Number 16637278; Reference Part Number (RPN)KCFW-10.0-38-40-RB: Order Number G32233, UDI (01)00827002322332(17)280610(10)16637282, Lot Number 16637282; Reference Part Number (RPN)KCFW-10.0-38-40-RB: Order Number G32233, UDI (01)00827002322332(17)280616(10)16644768, Lot Number 16644768; Reference Part Number (RPN)KCFW-10.0-38-40-RB: Order Number G32233, UDI (01)00827002322332(17)280617(10)16647072, Lot Number 16647072; Reference Part Number (RPN)KCFW-10.0-38-40-RB: Order Number G32233, UDI (01)00827002322332(17)280617(10)16647073, Lot Number 16647073; Reference Part Number (RPN)KCFW-10.0-38-40-RB: Order Number G32233, UDI (01)00827002322332(17)280624(10)16657904, Lot Number 16657904; Reference Part Number (RPN)KCFW-10.0-38-40-RB: Order Number G32233, UDI (01)00827002322332(17)280624(10)16657905, Lot Number 16657905; Reference Part Number (RPN)KCFW-10.0-38-40-RB: Order Number G32233, UDI (01)00827002322332(17)280630(10)16673098, Lot Number 16673098; Reference Part Number (RPN)KCFW-10.0-38-40-RB: Order Number G32233, UDI (01)00827002322332(17)280630(10)16673112, Lot Number 16673112; Reference Part Number (RPN)KCFW-10.0-38-40-RB: Order Number G32233, UDI (01)00827002322332(17)280630(10)16673113, Lot Number 16673113; Reference Part Number (RPN)KCFW-10.0-38-40-RB: Order Number G32233, UDI (01)00827002322332(17)280710(10)16688777, Lot Number 16688777; Reference Part Number (RPN)KCFW-10.0-38-40-RB: Order Number G32233, UDI (01)00827002322332(17)280710(10)16688778, Lot Number 16688778; Reference Part Number (RPN)KCFW-10.0-38-40-RB: Order Number G32233, UDI (01)00827002322332(17)280711(10)16690378, Lot Number 16690378; Reference Part Number (RPN)KCFW-10.0-38-40-RB: Order Number G32233, UDI (01)00827002322332(17)280715(10)16693991, Lot Number 16693991; Reference Part Number (RPN)KCFW-10.0-38-40-RB: Order Number G32233, UDI (01)00827002322332(17)280722(10)16704894, Lot Number 16704894; Reference Part Number (RPN)KCFW-10.0-38-40-RB: Order Number G32233, UDI (01)00827002322332(17)280722(10)16704906, Lot Number 16704906; Reference Part Number (RPN)KCFW-10.0-38-40-RB: Order Number G32233, UDI (01)00827002322332(17)280724(10)16709786, Lot Number 16709786; Reference Part Number (RPN)KCFW-10.0-38-40-RB: Order Number G32233, UDI (01)00827002322332(17)280724(10)16709787, Lot Number 16709787; Reference Part Number (RPN)KCFW-10.0-38-40-RB: Order Number G32233, UDI (01)00827002322332(17)280729(10)16716212, Lot Number 16716212; Reference Part Number (RPN)KCFW-10.0-38-40-RB: Order Number G32233, UDI (01)00827002322332(17)280729(10)16716213, Lot Number 16716213; Reference Part Number (RPN)KCFW-10.0-38-40-RB: Order Number G32233, UDI (01)00827002322332(17)280801(10)16721859, Lot Number 16721859; Reference Part Number (RPN)KCFW-10.0-38-40-RB: Order Number G32233, UDI (01)00827002322332(17)280801(10)16721860, Lot Number 16721860; Reference Part Number (RPN)KCFW-10.0-38-40-RB: Order Number G32233, UDI (01)00827002322332(17)280801(10)16721868, Lot Number 16721868; Reference Part Number (RPN)KCFW-10.0-38-40-RB: Order Number G32233, UDI (01)00827002322332(17)280801(10)16721875, Lot Number 16721875; Reference Part Number (RPN)KCFW-10.0-38-40-RB: Order Number G32233, UDI (01)00827002322332(17)280801(10)16721876, Lot Number 16721876; Reference Part Number (RPN)KCFW-10.0-38-40-RB: Order Number G32233, UDI (01)00827002322332(17)280515(10)16602829, Lot Number 16602829; Reference Part Number (RPN)KCFW-10.0-38-40-RB: Order Number G32233, UDI (01)00827002322332(17)280520(10)16607937, Lot Number 16607937; Reference Part Number (RPN)KCFW-10.0-38-40-RB: Order Number G32233, UDI (01)00827002322332(17)280523(10)16614632, Lot Number 16614632; Reference Part Number (RPN)KCFW-10.0-38-40-RB: Order Number G32233, UDI (01)00827002322332(17)280530(10)16623383, Lot Number 16623383; Reference Part Number (RPN)KCFW-10.0-38-40-RB: Order Number G32233, UDI (01)00827002322332(17)280605(10)16632466, Lot Number 16632466; Reference Part Number (RPN)KCFW-10.0-38-40-RB: Order Number G32233, UDI (01)00827002322332(17)280610(10)16637284, Lot Number 16637284; Reference Part Number (RPN)KCFW-10.0-38-40-RB: Order Number G32233, UDI (01)00827002322332(17)280611(10)16638969, Lot Number 16638969; Reference Part Number (RPN)KCFW-10.0-38-40-RB: Order Number G32233, UDI (01)00827002322332(17)280630(10)16673114, Lot Number 16673114; Reference Part Number (RPN)KCFW-10.0-38-40-RB: Order Number G32233, UDI (01)00827002322332(17)280613(10)16643080, Lot Number 16643080; Reference Part Number (RPN)KCFW-10.0-38-80-RB: Order Number G13033, UDI (01)00827002130333(17)280529(10)16621305, Lot Number 16621305; Reference Part Number (RPN)KCFW-10.0-38-80-RB: Order Number G13033, UDI (01)00827002130333(17)280523(10)16614616, Lot Number 16614616; Reference Part Number (RPN)KCFW-10.0-38-80-RB: Order Number G13033, UDI (01)00827002130333(17)280610(10)NS16637285, Lot Number NS16637285; Reference Part Number (RPN)KCFW-10.0-38-80-RB: Order Number G13033, UDI (01)00827002130333(17)280617(10)NS16647074, Lot Number NS16647074; Reference Part Number (RPN)KCFW-10.0-38-80-RB: Order Number G13033, UDI (01)00827002130333(17)280729(10)NS16716215, Lot Number NS16716215; Reference Part Number (RPN)KCFW-10.0-38-RB: Order Number G13031, UDI (01)00827002130319(17)280613(10)16643081, Lot Number 16643081; Reference Part Number (RPN)KCFW-10.0-38-RB: Order Number G13031, UDI (01)00827002130319(17)280715(10)16693981, Lot Number 16693981; Reference Part Number (RPN)KCFW-10.0-38-RB: Order Number G13031, UDI (01)00827002130319(17)280523(10)16614624, Lot Number 16614624; Reference Part Number (RPN)KCFW-10.0-38-RB: Order Number G13031, UDI (01)00827002130319(17)280611(10)16638970, Lot Number 16638970; Reference Part Number (RPN)KCFW-12.0-38-40-RB: Order Number G32373, UDI (01)00827002323735(17)280605(10)16632469, Lot Number 16632469; Reference Part Number (RPN)KCFW-12.0-38-40-RB: Order Number G32373, UDI (01)00827002323735(17)280708(10)16683354, Lot Number 16683354; Reference Part Number (RPN)KCFW-12.0-38-40-RB: Order Number G32373, UDI (01)00827002323735(17)280619(10)16652152, Lot Number 16652152; Reference Part Number (RPN)KCFW-12.0-38-80-RB: Order Number G49487, UDI (01)00827002494879(17)280806(10)16727445, Lot Number 16727445; Reference Part Number (RPN)KCFW-12.0-38-80-RB: Order Number G49487, UDI (01)00827002494879(17)280529(10)16621277, Lot Number 16621277; Reference Part Number (RPN)KCFW-12.0-38-80-RB: Order Number G49487, UDI (01)00827002494879(17)280603(10)16627324, Lot Number 16627324; Reference Part Number (RPN)KCFW-12.0-38-80-RB: Order Number G49487, UDI (01)00827002494879(17)280529(10)16621278, Lot Number 16621278; Reference Part Number (RPN)KCFW-12.0-38-80-RB: Order Number G49487, UDI (01)00827002494879(17)280731(10)16720362, Lot Number 16720362; Reference Part Number (RPN)KCFW-12.0-38-80-RB: Order Number G49487, UDI (01)00827002494879(17)280522(10)16613273, Lot Number 16613273; Reference Part Number (RPN)KCFW-12.0-38-80-RB: Order Number G49487, UDI (01)00827002494879(17)280523(10)16614607, Lot Number 16614607; Reference Part Number (RPN)KCFW-12.0-38-80-RB: Order Number G49487, UDI (01)00827002494879(17)280528(10)16618070, Lot Number 16618070.
• Recalling Firm/ Manufacturer: Cook Incorporated; 750 N Daniels Way; Bloomington IN 47404-9120
• For Additional Information Contact: Cook Medical Customer Relations Department; 800-457-4500
• Manufacturer Reason for Recall: 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.
• FDA Determined Cause: Process control
• Action: Cook Medical issued an URGENT: MEDICAL DEVICE RECALL notice to its consignees on 11/26/2025 by email and/or letter delivered via a courier. The notice explained the issue, risk to health, and requested the identification and return of the affected product. The notice must be shared with appropriate personnel, including down to the user level, within your organization or with any organization where the affected devices have been transferred. For questions or concerns, please contact Cook Medical Customer Relations at 800.457.4500 or 812.339.2235.
• Quantity in Commerce: 7952 units
• Distribution: Worldwide distribution.
• Total Product Life Cycle: TPLC Device Report

¹ A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
² Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
³ The manufacturer has initiated the recall and not all products have been corrected or removed. This record will be updated as the status changes.

• 510(K) Database: 510(K)s with Product Code = DYB