Covidien Endo GIA Suture Unit Recall: Safety Interlock Failure Risk
Covidien recalls Endo GIA Auto Suture Universal Articulating Loading Units due to potential safety interlock failure, which could allow firing an empty unit twice during surgery.
Use caution until it’s fixed
Potential for failure of the device safety interlock. The safety interlock prevents an empty single-use loading unit from being fired a second time.
Contact the company
What happened, in plain English
Covidien is recalling Endo GIA Auto Suture Universal Articulating Loading Units for possible safety interlock failure. This could allow the device to fire an empty unit twice during surgery, risking complications for patients. Read more at govinfonow.com/recall/73029-covidien-endo-gia-suture-unit-recall-safety-interlock-failure-risk.
Source Summary by GovInfoNow · govinfonow.com/recall/73029-covidien-endo-gia-suture-unit-recall-safety-interlock-failure-risk · Updated September 17, 2026 · FDA enforcement record: FDA #Z-0636-2018
Cite this page
“Covidien Endo GIA Suture Unit Recall: Safety Interlock Failure Risk.” GovInfoNow, updated September 17, 2026. https://govinfonow.com/recall/73029-covidien-endo-gia-suture-unit-recall-safety-interlock-failure-risk. Based on FDA recall #Z-0636-2018 (https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-0636-2018%22&limit=1).
Why it’s dangerous
The safety interlock is designed to prevent firing an empty single-use loading unit a second time. If this mechanism fails, the device could fire multiple times with an empty cartridge, potentially causing tissue damage or other complications during surgery.
Who’s affected
Surgical teams using the Endo GIA Auto Suture Universal Articulating Loading Units for abdominal, gynecologic, pediatric, or thoracic procedures are affected. Patients undergoing surgery with these devices are at risk of complications.
How to tell if you have this one
Check for model numbers N7F1058KX, N7F1121KX, N7F1056KX, or N7F1057KX on the device. These units were sold for use in abdominal, gynecologic, pediatric, and thoracic surgeries.
- Brand
Covidien- Category
Medical device
What to do — step by step
Check Device Model
Verify the model number on the device to confirm if it matches N7F1058KX, N7F1121KX, N7F1056KX, or N7F1057KX.
Where it went and when
Where it was distributed
Distributed nationwide.
FDA distribution: “Nationally” States read from FDA’s own wording; “not listed” means the notice does not name it.
Distributed nationwide.
Recall timeline
FDA terminated this recall 21 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-0636-2018 (September 13, 2017) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for Z-0636-2018 to see it in context.
- Plain-language summary written by qwen3:4b on September 17, 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.