Class II

Medical Device Recall: Tri-Staple 2.0 Black Reinforced Intelligent Reload- Applications in abdominal, gynecologic, pediatric and thoracic surgery for resection, transection of tissue and creation of anastomosis Model: SIG

Covidien, LP · April 15, 2024

Reason for Recall

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

Product Description

Tri-Staple 2.0 Black Reinforced Intelligent Reload- Applications in abdominal, gynecologic, pediatric and thoracic surgery for resection, transection of tissue and creation of anastomosis Model: SIGTRSB60AXT

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.

States Affected

NATIONWIDE

Quantity Affected

1681 units

Source: FDA (openFDA Device Enforcement)

Recall number: Z-1891-2024

Status: ongoing

SafeCheck provides drug interaction information from FDA-approved product labeling (openFDA). This is for informational purposes only and is not medical advice. Always consult your healthcare provider before making medication decisions.