Cook recalls Check=Flo Performer Introducer devices with incorrect sheath size that could cause complications during medical procedures.
Cook Medical identified that devices from the affected device lots may contain the incorrectly sized introducer sheath.
Cook is recalling Check=Flo Performer Introducer devices that may have the wrong-sized introducer sheath. This could lead to complications during medical procedures if used improperly.
The recalled devices may have an introducer sheath that is the wrong size. This could cause complications during medical procedures if the sheath doesn't fit properly.
Medical professionals using the Check=Flo Performer Introducer device are likely affected. Those with the specific model and lot numbers are at risk of using an incorrectly sized sheath.
Check for the Reference Part Number REF RCFW-14.0-0-38-30-RB or Order Number G08957 on the device. The lot number 16376242 is also associated with this recall.
Verify the Reference Part Number (REF RCFW-14.0-0-38-30-RB) or Order Number (G08957) on the device.
The Check=Flo Performer Introducer, 14.0Fr, with Reference Part Number REF RCFW-14.0-0-38-30-RB and Order Number G08957.
Lot number 16376242.
The recall does not require immediate stop use; check device details to confirm if it is affected.
We’ve drafted a message you can send Cook to request your refund or repair — edit it as you like.
Subject: Recall Z-1787-2025 — Cook Cook Hello, I own a Cook that is covered by recall Z-1787-2025 from Cook. I’m writing to arrange the remedy described in the recall (a refund, repair, or replacement as applicable). Could you please tell me the next steps to resolve this? Thank you.
Experiences, tips, and questions from readers. Every comment is reviewed before it appears.
No comments yet — be the first to share your experience.
The facts (hazard, remedy, dates, manufacturer) are pulled from the official FDA recall record. The plain-language summary and step-by-step checklist are written by GovInfoNow to make the official notice easier to act on — they don’t replace it.
