Z-1228-2023Class II

Tri-Staple 2.0 Black Intelligent Reload, Product Number SIG60AXT

Name: Z-1228-2023 Tri-Staple 2.0 Black Intelligent Reload, Product Number SIG60AXT
Creator: Covidien, LP
Published: 2023-01-25
License: https://open.fda.gov/license/

Medtronic, Inc. / initiated 2023-01-25 / Open, Classified

FDA source

Covidien, LP began a recall of Tri-Staple 2.0 Black Intelligent Reload, Product Number SIG60AXT on 2023-01-25. FDA classified it as Class II and gives the reason as "Affected lots have the potential for a broken sled vane, which may cause the reload to misfire leading to non-functional staple line closure, transecting tissue without forming staples, and tissue hang-up. These...". As of 2026-09-10, the recall status on record is Open, Classified.

Recall record

Recall number: Z-1228-2023
Classification: Class II
Status: Open, Classified
Initiated: 2023-01-25
Posted: 2023-03-06
Recalling firm: Medtronic, Inc.
Product: Tri-Staple 2.0 Black Intelligent Reload, Product Number SIG60AXT
Product code: GDW Staple, Implantable
Reason for recall: Affected lots have the potential for a broken sled vane, which may cause the reload to misfire leading to non-functional staple line closure, transecting tissue without forming staples, and tissue hang-up. These conditions may be associated to a delay to treatment, unspecified infection, hemorrhage/blood loss/bleeding, failure to anastomose, peritonitis, sepsis, pneumothorax, tissue trauma, or death.
FDA root cause: Process change control
Action: On January 25, 2023, the firm notified customers via Urgent Medical Device Recall letter. Customers were asked to take the following immediate actions: 1. Identify and quarantined all unused affected product. 2. Return unused affected product to Medtronic using the Customer Confirmation Form. 3. Forward the information to all who need to be aware within your organization, or to any organization where the affected product was transferred. There are no additional actions required for patients where a stapler in scope of this recall was used during a procedure. These patients should continue to be monitored in accordance with your medical facility s standard care protocols. If you have any questions regarding this communication, please contact your Medtronic Representative Customer Service at 800-962-9888, option 2.
Quantity in commerce: 264 US; 5056 OUS
Distribution: Worldwide distribution - US Nationwide distribution in the states of Arkansas, California, Florida, Georgia, Louisiana, Massachusetts, New York, North Carolina, Ohio, Washington and the countries of Australia, Austria, Belgium, Canada, Canary Islands, Denmark, Finland, France, Germany, Ireland, Italy, Kuwait, Netherlands, New Caledonia, Norway, Poland, Portugal, Spain, Sweden, Switzerland, United Kingdom.
Product codes and lots: UDI-DI (GTIN): 20884521543598 Lots: N2D0002Y, N2D0004Y, N2D0195Y

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-1228-2023
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-1228-2023	Class II	Ongoing	Voluntary: Firm initiated	2023-03-15	2023-03-06

Product code GDW

K160176Class IISignia StaplerCovidien / cleared 2016-04-26

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)