PlainRecalls
FDA Devices Moderate Class II Terminated

Covidien Endo GIA Ultra Universal Stapler 12 mm-intended for resection, transection in general surgery Item Code: EGIAUSTND

Reported: February 26, 2020 Initiated: January 17, 2020 #Z-1264-2020

Product Description

Covidien Endo GIA Ultra Universal Stapler 12 mm-intended for resection, transection in general surgery Item Code: EGIAUSTND

Reason for Recall

Potential for the sterile barrier to be compromised. Products with a compromised sterile barrier may result in a potentially increased risk for infection

Details

Recalling Firm
COVIDIEN LLC
Units Affected
2,180 units
Distribution
US Nationwide, Israel, and Japan
Location
Mansfield, MA

Frequently Asked Questions

What product was recalled?
Covidien Endo GIA Ultra Universal Stapler 12 mm-intended for resection, transection in general surgery Item Code: EGIAUSTND. Recalled by COVIDIEN LLC. Units affected: 2,180 units.
Why was this product recalled?
Potential for the sterile barrier to be compromised. Products with a compromised sterile barrier may result in a potentially increased risk for infection
Which agency issued this recall?
This recall was issued by the FDA Devices on February 26, 2020. Severity: Moderate. Recall number: Z-1264-2020.