Z-1891-2024Class II

Tri-Staple 2.0 Black Reinforced Intelligent Reload- Applications in abdominal, gynecologic, pediatric and...

Name: Z-1891-2024 Tri-Staple 2.0 Black Reinforced Intelligent Reload- Applications in abdominal, gynecologic, pediatric and...
Creator: Covidien, LP
Published: 2024-04-15
License: https://open.fda.gov/license/

Medtronic, Inc. / initiated 2024-04-15 / Open, Classified

FDA source

Covidien, LP began a recall of Tri-Staple 2.0 Black Reinforced Intelligent Reload- Applications in abdominal, gynecologic, pediatric and thoracic surgery for resection, transection of tissue... on 2024-04-15. FDA classified it as Class II and gives the reason as "Potential damage to the cartridge can result in poor staple formation and/or incomplete staple line, may cause a delay in surgery". As of 2026-09-10, the recall status on record is Open, Classified.

Recall record

Recall number: Z-1891-2024
Classification: Class II
Status: Open, Classified
Initiated: 2024-04-15
Posted: 2024-05-24
Recalling firm: Medtronic, Inc.
Product: 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
Product code: GDW Staple, Implantable
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
FDA root cause: Under Investigation by firm
Action: Medtronic issued Urgent Medical Device Recall letter on 4/15/24 via UPS 2-day. Letter states reason for recall, health risk and action to take: Customer Actions: " Immediately identify and quarantine all unused Tri-Staple" 2.0 Black Reinforced Intelligent Reload, Model SIGTRSB60AXT, from the specified lot(s) mentioned above. " Return all unused product in your inventory, corresponding to the specified lot(s) mentioned above, to Medtronic as indicated in the enclosed Customer Confirmation Form. Please complete the enclosed Customer Confirmation Form, even if you have no product to return. Pass on this information to all those who need to be aware within your organization or to any organization where the potentially affected devices have been transferred. Please keep a copy of this letter in your file. If you have any questions regarding this communication, please contact your Medtronic Representative Customer Service at 800-962-9888, option 2.
Quantity in commerce: 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.
Product codes and lots: GTIN: 10884521717633 20884521717630 Lot #: N3G1372Y

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-1891-2024
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-1891-2024	Class II	Ongoing	Voluntary: Firm initiated	2024-06-05	2024-05-24

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 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)