Covidien Llc: The product is recalled due to a manufacturing assembly error that may cause the staples to fail to properly advance within the staple cartridge when the instrument handle is compressed.

Agency Publication Date: June 3, 2020

Affected Products

Product: Multifire VersaTrack Auto Suture Hernia Stapler, 4.0mm, Part No. 174021 - Product Usage: has application in endoscopic general surgery procedures for fixation of mesh in the repair of hernial defects and in other surgical specialties for approximation of tissue(s).

Lots P9J0241Y P9J0242Y P9J0243Y P9K1140Y P9K1663Y P9K1141Y

Product: Multifire VersaTrack Auto Suture Hernia Stapler, 4.8mm, Part No. 174023 - Product Usage: has application in endoscopic general surgery procedures for fixation of mesh in the repair of hernial defects and in other surgical specialties for approximation of tissue(s).

Lots P9J1172Y P9K0452Y P9K0453Y P9K0454Y P9K1596Y P0B0996Y

Product: Multifire Endo Hernia 0 12mm Stapler with 4.8mm Disposable Loading Unit , Part No. 174025 - Product Usage: has application in endoscopic general surgery procedures for fixation of mesh in the repair of hernial defects and in other surgical specialties for approximation of tissue(s).

Lots P9J1171Y P9K1395Y P9K1582Y

Product: Multifire Endo Hernia 0 12mm Stapler with 4.0mm Disposable Loading Unit , Part No. 174027 - Product Usage: has application in endoscopic general surgery procedures for fixation of mesh in the repair of hernial defects and in other surgical specialties for approximation of tissue(s).

Lots P9J0368Y P9J0369Y P9J0517Y P9K1300Y

Additional Information

Agency: Food and Drug Administration (FDA)

Event ID: 85689

Status: Active

Manufacturer: Covidien Llc

Manufactured In: United States

Units Affected: 4 products (12,610 total)

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AI-Enhanced Content: The summary, action steps, and risk assessment on this page were generated by AI from official government recall data to improve readability. This is not legal or medical advice. Always refer to the official agency sources below for authoritative information.

Sources: FDA iRES · Raw API Response

openFDA Disclaimer: This recall information is sourced from the openFDA API. Do not rely on openFDA to make decisions regarding medical care. While we make every effort to ensure that data is accurate, you should assume all results are unvalidated. Refer to the openFDA terms of service for more information.

Affected Products

Lots P9J0241Y P9J0242Y P9J0243Y P9K1140Y P9K1663Y P9K1141Y

Lots P9J1172Y P9K0452Y P9K0453Y P9K0454Y P9K1596Y P0B0996Y

Lots P9J1171Y P9K1395Y P9K1582Y

Lots P9J0368Y P9J0369Y P9J0517Y P9K1300Y