Endo GIA Auto Suture Universal Articulating Loading Unit… recallZ-0636-2018 · Covidien LLC · initiated Sep 13, 2017
Class II Terminated All recalls posted in February 2018
Is my device affected?
- Compare the model, catalog and lot or serial numbers on your device or its packaging with the code information below. A recall usually covers only specific models or lots.
- If yours is listed, follow the instructions from Covidien LLC or your healthcare provider. The company's action is summarized under what the company is doing.
- Do not stop using a prescribed or implanted device on your own — talk to your healthcare provider first.
Where to find your model and lot numbers · What recall classes and statuses mean
Why it was recalled
Potential for failure of the device safety interlock. The safety interlock prevents an empty single-use loading unit from being fired a second time.
FDA root cause category: Under Investigation by firm
What the company is doing
All consignees were notified via Federal Express or certified mail on September 13, 2017, and the letter informs customers of the potential for failure of the device safety interlock and the actions they should take. Customers are requested to acknowledge receipt and understanding of the Urgent Field Corrective Action Notice. All in control inventory and product returned from customers will be scrapped.
Recall details
- Recall number
- Z-0636-2018
- Recall class
- Class II
- Status
- Terminated
- Initiated by the company
- Sep 13, 2017
- Posted by the FDA
- Feb 16, 2018
- Recalling firm
- Covidien LLC
- Quantity
- 3,816
- Product code
- GDW
- FDA submissions
- K111825
- Distribution
- Nationally
Product description
Endo GIA Auto Suture Universal Articulating Loading Unit for use in abdominal, gynecologic, pediatric and thoracic surgery for resection, transection and creation of anastomosis.
Code information (models, lots, serial numbers)
N7F1058KX, N7F1121KX, N7F1056KX, N7F1057KX
Other devices under the same FDA submission
77 devices cleared under K111825 — the recall does not name any of them by identifier. One submission often covers many models, so they may or may not be affected.
- Endo GIA EGIA60AMTCovidien LP · STAPLE, IMPLANTABLE19 deaths10,680 reports
- Endo GIA Ultra EGIAUSTNDCovidien LP · STAPLE, IMPLANTABLE5 deaths9,730 reports
- Endo GIA Ultra EGIAUSHORTCovidien LP · STAPLE, IMPLANTABLE2 deaths3,011 reports
- Endo GIA EGIA45AMTCovidien LP · STAPLE, IMPLANTABLE10 deaths2,965 reports
- Endo GIA Ultra EGIAUXLCovidien LP · STAPLE, IMPLANTABLE2,909 reports
- Endo GIA EGIA45AVMCovidien LP · STAPLE, IMPLANTABLE7 deaths1,583 reports
- Endo GIA EGIA60AVMCovidien LP · STAPLE, IMPLANTABLE9 deaths1,438 reports
- GIA GIA8038SCovidien LP · STAPLE, IMPLANTABLE12 deaths1,237 reports
- Endo GIA 030458Covidien LP · STAPLE, IMPLANTABLE1 recall1 death948 reports
- Endo GIA EGIA60AXTCovidien LP · STAPLE, IMPLANTABLE4 deaths987 reports
- Endo GIA 030415Covidien LP · STAPLE, IMPLANTABLE973 reports
- Endo GIA 030449Covidien LP · STAPLE, IMPLANTABLE2 deaths716 reports
Sources and updates
- Recall record: FDA Medical Device Recalls, file dated Oct 16, 2026 · View the FDA recall notice ↗
- Devices: FDA GUDID, file dated Oct 13, 2026. Devices are linked when their identifier (with a valid check digit) appears in the recall's code information.
- Page last rebuilt: Oct 18, 2026. Text above is shown as published by the FDA.
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