Z-1419-2021Class II

Covidien Tri-Staple 2.0 Reinforced Intelligent Reload 60 mm Medium/Thick-For use with Signia stapling system...

Name: Z-1419-2021 Covidien Tri-Staple 2.0 Reinforced Intelligent Reload 60 mm Medium/Thick-For use with Signia stapling system...
Creator: Covidien Llc
Published: 2021-03-23
License: https://open.fda.gov/license/

Medtronic, Inc. / initiated 2021-03-23 / Terminated / root cause: manufacturing process

FDA source

Covidien Llc began a recall of Covidien Tri-Staple 2.0 Reinforced Intelligent Reload 60 mm Medium/Thick-For use with Signia stapling system. Staple line reinforcement has applications in... on 2021-03-23. FDA classified it as Class II and gives the reason as "Potential for the pouch to contain an extra laminate layer, creating the potential for the device sterility to be compromised. The inclusion of an additional laminate layer in the package may also impact complete...". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as manufacturing process.

Recall record

Recall number: Z-1419-2021
Classification: Class II
Status: Terminated
Initiated: 2021-03-23
Posted: 2021-04-13
Terminated: 2024-05-15
Recalling firm: Medtronic, Inc.
Product: Covidien Tri-Staple 2.0 Reinforced Intelligent Reload 60 mm Medium/Thick-For use with Signia stapling system. Staple line reinforcement has applications in abdominal, gynecologic, pediatric and thoracic surgery for resection, transection of tissue and creation of anastomosis. It may be used for transection and resection of liver substance, hepatic vasculature and biliary structures, and for transection and resection of pancreas. Product Number: SIGTRSB60AMT
Product code: GDW Staple, Implantable
Reason for recall: Potential for the pouch to contain an extra laminate layer, creating the potential for the device sterility to be compromised. The inclusion of an additional laminate layer in the package may also impact complete de-gassing of the sterilization gas, Ethylene Oxide and may result in a potentially increased risk for patient infection and/or potential exposure to Ethylene Oxide retained in the pouch
Root cause tag: manufacturing process
FDA root cause: Nonconforming Material/Component
Action: Medtronic notified consignees by letter delivered via Federal Express and/or certified mail beginning March 23, 2021. The letter states reason for recall, health risk and action to take: " Immediately quarantine and discontinue use of the affected item code and lot. " Return affected product. " Forward the information to anyone who they have distributed affected Covidien Tri-Staple" 2.0 Reinforced Intelligent Reloads. " Complete the Recalled Product Return Form Questions regarding this communication, please contact your Medtronic representative or Customer Service at 800-962-9888, option 2.
Quantity in commerce: 222 units
Distribution: AL, AR, FL, IN, LA, MA , MN, MO, NJ, NY, OR, PA, TX
Product codes and lots: Lot Number: N0M0801RY Exp. Date: ¿11/30/2023 UDI: A8845217176201 20884521717623

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-1419-2021
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-1419-2021	Class II	Terminated	Voluntary: Firm initiated	2021-04-21	2021-04-13

Product code GDW

K173270Class IITri-Staple 2.0 Reinforced ReloadCovidien / cleared 2018-02-20

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-10-07, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)