Cook Entuit Secure Gastrointestinal Suture Anchor Set Recall: Sliding Mechanism Risk
Cook recalls Entuit Secure Gastrointestinal Suture Anchor Sets with specific lot numbers due to potential difficulty sliding down the retention mechanism. Affected units may require replacement to prevent complications during medical procedures.
Lower-risk recall
There is a potential for difficulty in sliding down the retention mechanism on the sets manufactured with a specific extension spring lot.
Contact the company
What happened, in plain English
Cook is recalling certain Entuit Secure Gastrointestinal Suture Anchor Sets because a specific extension spring lot may cause the device to slide down the retention mechanism. This could lead to complications during medical procedures if the device is not properly secured. Read more at govinfonow.com/recall/69306-cook-entuit-secure-gastrointestinal-suture-anchor-set-recall-sliding-mechanism.
Source Summary by GovInfoNow · govinfonow.com/recall/69306-cook-entuit-secure-gastrointestinal-suture-anchor-set-recall-sliding-mechanism · Updated August 20, 2026 · FDA enforcement record: FDA #Z-0968-2019
Cite this page
“Cook Entuit Secure Gastrointestinal Suture Anchor Set Recall: Sliding Mechanism Risk.” GovInfoNow, updated August 20, 2026. https://govinfonow.com/recall/69306-cook-entuit-secure-gastrointestinal-suture-anchor-set-recall-sliding-mechanism. Based on FDA recall #Z-0968-2019 (https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-0968-2019%22&limit=1).
Why it’s dangerous
The device may slide down the retention mechanism due to a specific extension spring lot. This could cause the device to become loose during medical procedures, potentially leading to complications.
Who’s affected
Medical professionals using the Entuit Secure Gastrointestinal Suture Anchor Set for stomach procedures are most at risk. Patients undergoing surgery with this device may be affected if the set is recalled.
How to tell if you have this one
Check the lot numbers listed: 8056941, 8135292, 8165522, 8228910, 8261265, 8293447, 8331165, 8357394, 8389427, 8395982, 8445405, 8471250, 8483543, 8511203, 8556989, 8557006, 8564659, 8622758, 8628912, 8663134. The product is sold under Catalog Number GIAS-SRM-3 and Order Number G35570.
- Brand
Cook- Category
Medical device
All 2 products in this recall
FDA lists each product line separately under one recall event. Check your product description, lot or code numbers against each row. Every row shares the hazard and remedy on this page.
- Classification
Class II- Status
Terminated- Distribution
Worldwide Distribution: US (nationwide) to of states: AL, AZ, CA, GA, HI, IL, IN, KY, LA, MI, MN, MO, NC, NJ, NY, OH, PA, RI, TN, TX, and UT; and countries of: Austria, Belgium, Canada, Denmark, France, Germany, Great Britain, Hungary, Iceland, Italy, Netherlands, Norway, Spain, and Switzerland.
| Recall number | Product, codes & lots | Quantity |
|---|---|---|
| Z-0967-2019 | Entuit Secure Gastrointestinal Suture Anchor Set, Catalog Number GIAS-SRM-2, Order Number G35569 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.; Lot numbers 8144390,8159665, 8173295, 8204594, 8261263,8294836, 8308856, 8331166, 8395981, 8459751, 8471244, 8511162, 8535303, 8541938, 8574041, 8582863, 8597539, 8541938X, 8582863X | 797 |
| Z-0968-2019 | 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.; Lot numbers 8056941,8135292, 8165522, 8228910, 8261265, 8293447, 8331165, 8357394, 8389427,8395982, 8445405, 8471250, 8483543, 8511203, 8556989, 8557006, 8564659, 8622758, 8628912, 8663134 | 975 |
What to do — step by step
Check Lot Numbers
Identify the lot numbers on your device to see if they match the listed numbers: 8056941, 8135292, 8165522, 8228910, 8261265, 8293447, 8331165, 8357394, 8389427, 8395982, 8445405, 8471250, 8483543, 8511203, 8556989, 8557006, 8564659, 8622758, 8628912, 8663134.
Where it went and when
Where it was distributed
Distributed nationwide and abroad; the notice names 21 states.
FDA distribution: “Worldwide Distribution: US (nationwide) to of states: AL, AZ, CA, GA, HI, IL, IN, KY, LA, MI, MN, MO, NC, NJ, NY, OH, PA, RI, TN, TX, and UT; and countries of: Austria, Belgium, Canada, Denmark, France, Germany, Great Britain, Hungary,…” States read from FDA’s own wording; “not listed” means the notice does not name it.
Named in the notice: Alabama, Arizona, California, Georgia, Hawaii, Illinois, Indiana, Kentucky, Louisiana, Michigan, Minnesota, Missouri, New Jersey, New York, North Carolina, Ohio, Pennsylvania, Rhode Island, Tennessee, Texas, Utah.
Recall timeline
FDA terminated this recall 16 months after the firm started it.
- Firm started the recall
- FDA classified it Class II
- Published in FDA’s Enforcement Report
- FDA terminated the recall
Dates from the agency record only; steps without a date are left out.
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Where this comes from
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.
- Official source: FDA Recall #Z-0968-2019 (December 19, 2018) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for Z-0968-2019 to see it in context.
- Plain-language summary written by qwen3:4b on August 20, 2026, from the official record above. Not reviewed by a person — if it conflicts with the FDA notice, the notice is correct. Report an error on this page.
- GovInfoNow is an independent service and is not a government agency. We republish official FDA recall data; we don’t issue, amend or administer recalls.