Endo GIA Auto Suture Universal Articulating Loading Unit 30 mm - 2.5 mm, Item Code 030451 - Product Usage: The Endo GIA universal staplers have applications in abdominal, gynecologic, pediatric and thoracic surgery for resection, transection and creation of anastomosis. Recall
Check Your Product
According to the U.S. Food and Drug Administration (FDA)
Product
Endo GIA Auto Suture Universal Articulating Loading Unit 30 mm - 2.5 mm, Item Code 030451 - Product Usage: The Endo GIA universal staplers have applications in abdominal, gynecologic, pediatric and thoracic surgery for resection, transection and creation of anastomosis.
Lot Codes / Batch Numbers
Not specified in FDA notice. Check official source for details.
Products Sold
Lot Numbers: T0A016X T8D009X T8E058X T8H024X T9D052X T0B130X T8D010X T8E069X T8H025X T9D149X T0D070X T8D012X T8H004X T8H061X T9E081X T7H001X T8D013X T8H008X T8M044X T9E082X T7L024X T8D041X T8H009X T9A032X T9F133X T7L025X T8D042X T8H010X T9A033X T9G029X T8B012X T8D043X T8H011X T9A082X T9G037X T8B013X T8D044X T8H012X T9B039X T9G085X T8C026X T8D045X T8H013X T9B040X T9G086X T8C027X T8D046X T8H014X T9D043X T9G093X T8C045X T8E049X T8H022X T9D050X T9K069X T8C046X T8E050X T8H023X T9D051X T9M069X T8C047X T8E057X
A medical device manufacturer is recalling Endo GIA Auto Suture Universal Articulating Loading Unit 30 mm - 2.5 mm, Item Code 030451 - Product due to The device staples may not properly form upon application preventing adequate hemostasis. Use of a product with this assembly error may result in inc. Based on FDA medical device recall database.
Summary derived from FDA notice
Reason for Recall
As stated by FDA
The device staples may not properly form upon application preventing adequate hemostasis. Use of a product with this assembly error may result in incomplete staple formation.
Recommended Action
Per FDA guidance
Urgent Medical Device Recall notification letters dated 8/12/20 were sent to customers. Required Actions: 1.Please immediately quarantine and discontinue use of affected item codes with associated lot numbers listedon Attachment A. 2.Please return affected product as indicated below. All unused products from the affected item codes and associated lot numbers must be returned. 3.If you have distributed the Covidien Endo GIA" Auto Suture" universal articulating loading units listed on Attachment A, please promptly forward the information from this letter to those recipients. 4.Complete the Recalled Product Return Form even if you do not have inventory. We regret any inconvenience this may cause. We are committed to patient safety and appreciate your prompt attention to this matter. If you have any questions regarding this communication, please contact your Medtronic representative or Customer Service at 800-962-9888, option 2.
Verify this information on the official source
For complete details and official instructions, check the U.S. Food and Drug Administration (FDA) directly.
View official FDA recall noticePage updated: Jan 10, 2026