Covidien Endo GIA AutoSuture Universal Loading Unit… recallZ-1063-2013 · Covidien LP · initiated Feb 11, 2013
Class II Terminated All recalls posted in April 2013
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 LP 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
Single Use Loading Unit contained two staples loaded in each cartridge pocket and may result in difficulty firing and removing the device from the application site, which may require medical intervention
FDA root cause category: Process control
What the company is doing
Covidien notified customers with an Urgent Medical Device Recall notification on February 11, 2013. The letter identified the affected product and the reason for the recall. Accounts were requested to quarantine and discontinue use of the affected devices, and notify Universal Loading Unit 30mm-2.0mm users of this recall. Customers should follow the instructions provided in order to return the affected product. Customers are to complete and return the Product Return Form regardless if they have any affected product or not. For questions regarding the RGA I return process, please contact Covidien Customer Service, M-F, 8 am - 6:30 pm ET at (800) 962-9888, option 1, and then option 2.
Recall details
- Recall number
- Z-1063-2013
- Recall class
- Class II
- Status
- Terminated
- Initiated by the company
- Feb 11, 2013
- Posted by the FDA
- Apr 5, 2013
- Recalling firm
- Covidien LP
- Quantity
- 6,751 units
- Product code
- GDW
- FDA submissions
- K111825
- Distribution
- Worldwide Distribution -- USA, Asia Pacific, Canada, Europe, and Japan.
Product description
Covidien Endo GIA AutoSuture Universal Loading Unit, 30mm-2.0mm Product Code: 030450 Applications in abdominal, gynecologic, pediatric anti thoracic surgery for resection, transection and creation of anastomosis.
Code information (models, lots, serial numbers)
Lot Codes: N2F0563LX, N2F0341LX, N2F0725LX, and N2E0605LX.
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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