Cook Incorporated: Medical Device Recall in 2025 - (Recall #: Z-1786-2025)

Updated on March 25, 2026.

See the recall detail below. You can also see other recalls from the same firm in 2025.

Data Source: FDA.

Product Description:

Check=Flo Performer Introducer, 10.0Fr, Reference Part Number(RPN) REF RCFW-10.0-0-38-30-RB, Order Number (GPN) REF G08686,

Product Classification:

Class II

Date Initiated: April 17, 2025

Date Posted: May 28, 2025

Recall Number: Z-1786-2025

Event ID: 96703

Reason for Recall:

Cook Medical identified that devices from the affected device lots may contain the incorrectly sized introducer sheath.

Status: Ongoing

Product Quantity: 99 units

Code Information:

UDI/DI 00827002086869, Lot Number 16376248

Distribution Pattern:

Worldwide distribution - US Nationwide and the countries of Belgium, Germany, Spain, France, Ireland, Italy Netherlands, Switzerland, South Africa, Slovenia.

Voluntary or Mandated:

Voluntary: Firm initiated