Z-1063-2013Class II

Covidien Endo GIA AutoSuture Universal Loading Unit, 30mm-2.0mm

Name: Z-1063-2013 Covidien Endo GIA AutoSuture Universal Loading Unit, 30mm-2.0mm
Creator: Covidien LP
Published: 2013-02-11
License: https://open.fda.gov/license/

Medtronic, Inc. / initiated 2013-02-11 / Terminated / root cause: manufacturing process

FDA source

Covidien LP began a recall of Covidien Endo GIA AutoSuture Universal Loading Unit, 30mm-2.0mm Product Code: 030450 Applications in abdominal, gynecologic, pediatric anti thoracic surgery... on 2013-02-11. FDA classified it as Class II and gives the reason as "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". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as manufacturing process.

Recall record

Recall number: Z-1063-2013
Classification: Class II
Status: Terminated
Initiated: 2013-02-11
Posted: 2013-04-05
Terminated: 2014-03-20
Recalling firm: Medtronic, Inc.
Product: 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.
Product code: GDW Staple, Implantable
Reason for recall: 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
Root cause tag: manufacturing process
FDA root cause: Process control
Action: 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.
Quantity in commerce: 6,751 units
Distribution: Worldwide Distribution -- USA, Asia Pacific, Canada, Europe, and Japan.
Product codes and lots: Lot Codes: N2F0563LX, N2F0341LX, N2F0725LX, and N2E0605LX.

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-1063-2013
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-1063-2013	Class II	Terminated	Voluntary: Firm initiated	2013-04-17	2013-04-05

Product code GDW

K111825Class IIEndo Gia(tm) Staplers, Dst Series(tm) Gia(tm) Staplers, Dst Series(tm) Ta(tm) StaplersCovidien, Formerly US Surgical A Divison of Tyco H / cleared 2011-10-25

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-10-07, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)