FDAClass IIFebruary 26, 2020

Covidien Endo GIA Ultra Universal Stapler 12 recall: Sterility Concern

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

Why was Covidien Endo GIA Ultra Universal Stapler 12 recalled?

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

What should I do if I have this product?

Review the official FDA enforcement record for current instructions.

What to do with a recalled product: refunds, receipts, safe disposal and how to report a problem.

Is my product affected?

Compare the item in your hand with every identifier below from the official FDA record. Only products that match the listed product and lot, UPC or model codes are part of this recall.

Which lot codes, UPCs or models are affected?

Lot Number: P9E0022Y

Product
Covidien Endo GIA Ultra Universal Stapler 12 mm-intended for resection, transection in general surgery Item Code: EGIAUSTND
Recalling firm
COVIDIEN LLC
Quantity
2,180 units
Distribution
US Nationwide, Israel, and Japan
Recall date
February 26, 2020
Classification
Class II
Status
Terminated
Agency
FDA (device)
Open FDA enforcement record Latest recalls