Potential health hazard — use of or exposure to this product may cause temporary or medically reversible adverse health consequences.
Entuit Secure Adjustable Gastrointestinal Suture Anchor Set - Intended for Recalled by Cook Incorporated Due to Packaging may have low seal strength and not...
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 Incorporated directly.
Affected Products
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
Quantity: 8 units
Why Was This Recalled?
Packaging may have low seal strength and not meet peel strength specifications, compromising device sterility
Where Was This Sold?
This product was distributed nationwide across all 50 states.
About Cook Incorporated
Cook Incorporated has 64 total recalls tracked by RecallDetector.
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Data sourced from the FDA (Device). Last updated March 26, 2026. View original report