Cook Flexor Check-Flo Introducers and Sets: Manufacturing Defect Risk

The Food and Drug Administration announced on Nov. 26, 2025, that Cook Incorporated is recalling Flexor Check-Flo Introducers and Sets because they may have been manufactured out of specification. The agency said the devices could be cut to incorrect lengths or improperly trimmed.

How to tell if you have it

• Brand: Cook
• Product: Flexor Check-Flo Introducers and Sets
• Reference Part Numbers: KCFW-9.0-18/38-45-RB-ANL0-HC, KCFW-9.0-18/38-45-RB-ANL1-HC, KCFW-10.0-35-45-RB-HFANL0-HC, KCFW-10.0-35-45-RB-HFANL1-HC, KCFW-12.0-35-45-RB-HFANL0-HC, KCFW-12.0-35-45-RB-HFANL1-HC, KCFW-9.0-35-38.5-RB-RTPS-100, KCFW-10.0-35-RB-RTPS-100, KCFW-9.0-38-55-RB-RAABE, KCFW-9.0-38-70-RB-RAABE, KCFW-9.0-38-80-RB, KCFW-10.0-38-30-RB, KCFW-10.0-38-40-RB, KCFW-10.0-38-80-RB, KCFW-10.0-38-RB, KCFW-12.0-38-40-RB, KCFW-12.0-38-80-RB
• UPCs: 00827002094420, 00827002126060, 00827002130319, 00827002130326, 00827002130333, 00827002130814, 00827002131606, 00827002322332, 00827002323735, 00827002363939, 00827002477001, 00827002477018, 00827002491014, 00827002491021, 00827002494879
• Units affected: 7952

The hazard

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.

Context

GovInfoNow's records show Cook Incorporated has 15 other recalls on record since May 5, 2022. Other recent recalls of similar products include Cook Aurous Sizing Catheters Recall (April 2, 2026), Cook Medical Approach CTO-18 Micro Wire Guide Recall (March 5, 2026), and Cook Beacon Tip 5.0 Fr Angiographic Catheters Recall (May 15, 2025). Other recent recalls of similar products include Wilson-Cook Instinct Plus Endoscopic Clipping Device Recall (March 3, 2026) and Philips Allura Xper FD10F Medical System Recall (Dec. 15, 2025).