Agency classClass IIOur severity:High FDA (Devices)·Z-1529-2024·Announced 2024-04-24

Gastrointestinal Suture Anchor Recalled Due to Packaging Seal Defect

Cook Incorporated is recalling the Entuit Secure Adjustable Gastrointestinal Suture Anchor Set due to packaging that may have insufficient seal strength, potentially compromising device sterility. The recalled lot is distributed worldwide.

The agency’s classification

FDA (Devices): Class II

Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.

This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work

What this means for you

Our assessment, not the agency’s: severity 3/5 (High).

Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.

Our severity reasoning: This is an FDA Class II device with potential for sterility compromise, a significant risk for surgical implants. No illnesses or injuries have been reported, making this a risk-of-harm scenario with theoretical hazard.

Plain-English summary

Cook Incorporated is recalling the Entuit Secure Adjustable Gastrointestinal Suture Anchor Set (Reference Part Number GIAS-SRM-ADJ-2) from lot 15791906. The affected packaging may have low seal strength and does not meet peel strength specifications, which could compromise the sterility of the device.

This surgical anchor is intended for anchoring the anterior wall of the stomach to the abdominal wall prior to introduction of interventional catheters. The recalled lot has been distributed worldwide, including throughout the United States, Canada, and multiple other countries.

Healthcare facilities that have received this device should verify whether they have units from the affected lot 15791906 and contact Cook Incorporated for further instructions.

The recalled product

Product: Entuit Secure Adjustable Gastrointestinal Suture Anchor Set - Intended for anchoring the anterior wall of the stomach to the abdominal wall prior to introduction of interventional catheters. REFERENCE PART NUMBER (RPN): GIAS-SRM-ADJ-2 ORDER NUMBER (GPN): G35562
Manufacturer: Cook Incorporated
Category: Medical Device — Surgical Anchor
Hazard: sterility-compromise
contamination-risk
Affected units: 8

Is your product affected?

Check your packaging against the codes below. If any of them match, the product is part of this recall.

Lot numbers (1)

UDI-DI: (01)00827002355620(17) Lot Number: 15791906

Distribution

Distributed nationwide across the United States.

The notice also names 4 states specifically:

Part of a larger recall action

This product is one of 8 recalled by Cook Incorporated under a single FDA (Devices) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.

See all 8 products in this recall →

Same manufacturer · Cook Incorporated

See all →

Moderate
Cook Williams Cystoscopic Injection Needles Recalled for Manufacturing Defect
FDA (Devices) · 2026-10-21
Critical
Aurous Centimeter Sizing Catheter Recalled for Marker Band Cracking Risk
FDA (Devices) · 2026-05-13
Severe
Beacon Tip Centimeter Sizing Catheter recalled for cracking marker bands
FDA (Devices) · 2026-05-13
Critical
Cook Centimeter Sizing Catheter recall due to marker band cracking
FDA (Devices) · 2026-05-13
High
Cook Medical CTO-18 wire guides labeled with overstated expiration dates
FDA (Devices) · 2026-04-15

Same hazard · sterility compromise