Class II — Potential Health Hazard

Potential health hazard — use of or exposure to this product may cause temporary or medically reversible adverse health consequences.

Entuit Secure Gastrointestinal Suture Anchor Set Recalled by Cook Inc. Due to There is a potential for difficulty in sliding...

Date: December 19, 2018
Company: Cook Inc.
Status: Terminated
Source: FDA (Device)

What You Should Do

Stop using this product immediately. Do not consume, use, or distribute it.

Return the product to the place of purchase for a full refund. If you have questions, contact Cook Inc. directly.

Affected Products

Entuit Secure Gastrointestinal Suture Anchor Set, Catalog Number GIAS-SRM-3, Order Number G35570 The Entuit Secure Gastrointestinal Suture Anchor Set is intended for anchoring the anterior wall of the stomach to the abdominal wall prior to the introduction of interventional catheters.

Quantity: 975

Why Was This Recalled?

There is a potential for difficulty in sliding down the retention mechanism on the sets manufactured with a specific extension spring lot.

Where Was This Sold?

This product was distributed nationwide across all 50 states.

Affected (51 states)Not affected

About Cook Inc.

Cook Inc. has 262 total recalls tracked by RecallDetector.

Related Recalls

Data sourced from the FDA (Device). Last updated March 26, 2026. View original report