FDA recall Z-1264-2020

Product

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

Distribution

US Nationwide, Israel, and Japan

Key facts

Status

Terminated

Initiation date

2020-01-17

Report date

2020-02-26

Termination date

2022-07-29

Voluntary/Mandated

Voluntary: Firm initiated

Location

Mansfield, MA, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1264-2020