FDAClass IIJune 5, 2024

Tri-Staple 2.0 Black Reinforced Intelligent Reload recall

Tri-Staple 2.0 Black Reinforced Intelligent Reload- Applications in abdominal, gynecologic, pediatric and thoracic surgery for resection, transection…

Why was Tri-Staple 2.0 Black Reinforced Intelligent Reload recalled?

Potential damage to the cartridge can result in poor staple formation and/or incomplete staple line, may cause a delay in surgery

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?

GTIN: 10884521717633 20884521717630 Lot #: N3G1372Y

Product
Tri-Staple 2.0 Black Reinforced Intelligent Reload- Applications in abdominal, gynecologic, pediatric and thoracic surgery for resection, transection…
Recalling firm
Covidien, LP
Quantity
1681 units
Distribution
Worldwide - US Nationwide distribution in the state of NJ and the countries of Australia, Japan, New Zealand, Saudi Arabia, Singapore, South Africa, Taiwan, Thailand.
Recall date
June 5, 2024
Classification
Class II
Status
Ongoing
Agency
FDA (device)
Open FDA enforcement record Latest recalls