Covidien LLC EGIA45 CT AR MD THK REL, EGIA45CTAMT Recall
Hazard assessment based on recall description.
This AI-generated summary is provided for general informational purposes only and is derived from publicly available recall notices. It supplements but does not replace official agency classifications or safety instructions.
Check Your Product
According to the U.S. Food and Drug Administration (FDA)
Product
EGIA45 CT AR MD THK REL, EGIA45CTAMT
Brand
Covidien LLC
Lot Codes / Batch Numbers
N8L0401KY
Products Sold
N8L0401KY
Covidien LLC is recalling EGIA45 CT AR MD THK REL, EGIA45CTAMT due to The device may be missing one of two pin components that maintain alignment of the device jaws, resulting in incomplete staple formation which may lea. Based on FDA medical device recall database.
Summary derived from FDA notice
Reason for Recall
As stated by FDA
The device may be missing one of two pin components that maintain alignment of the device jaws, resulting in incomplete staple formation which may lead to bleeding, anastomotic leak, peritonitis, or pneumothorax which can result in the potential for infection and/or sepsis.
Recommended Action
Per FDA guidance
All consignees were notified by letter delivered via Federal Express and/or certified mail beginning May 17, 2019. The letter informs customers of the recall of specific item codes and production lots of Covidien Endo GIA Articulating Reloads with Tri-Staple Technology due to the potential for a device to be missing one of two pin components that maintain alignment of the device jaws. Through this notification customers are instructed to take the following actions: " Immediately quarantine and discontinue use of the affected item codes and lots. " Return affected product. " Forward the information to anyone who they have distributed affected Covidien Endo GIA" Articulating Reloads with Tri-Staple Technology. " Complete the Recalled Product Return Form. 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