FDAClass IIJune 26, 2019

Egia 30 Articulating MED Thick Sulu recall

EGIA 30 ARTICULATING MED THICK SULU, Item Code EGIA30AMT

Why was Egia 30 Articulating MED Thick Sulu recalled?

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.

What should I do if I have this product?

The recall is ongoing. Follow the firm and FDA 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?

lots N5A0871KX N7A0527KX N7E0441KX N8J0039KX N8J0527KX N8J0820KX

Product
EGIA 30 ARTICULATING MED THICK SULU, Item Code EGIA30AMT
Recalling firm
Covidien LLC
Quantity
3,113,280
Distribution
Nationwide domestic distribution, worldwide foreign distribution.
Recall date
June 26, 2019
Classification
Class II
Status
Ongoing
Agency
FDA (device)
Open FDA enforcement record Latest recalls