FDA Medical Device Recalls (openFDA)
Covidien, LP: Tri-Staple 2.0 Black Intelligent Reload, Product Number SIG60AXT
- Recall number
- Z-1228-2023
- Recalling firm
- Covidien, LP
- Product
- Tri-Staple 2.0 Black Intelligent Reload, Product Number SIG60AXT
- Status
- Open, Classified
- Initiated
- 2023-01-25
- Posted
- 2023-03-06
- Terminated
- not on file
- Reason
- 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.
- 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
- 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.
- Lot, serial or model codes
- UDI-DI (GTIN): 20884521543598 Lots: N2D0002Y, N2D0004Y, N2D0195Y
- 510(k) numbers
- ["K160176"]
- PMA numbers
- not on file
- Product code
- GDW
- Firm FEI
- 1219930
- Firm city
- North Haven
- Firm state
- CT
- Firm country
- not on file
Where this comes from
- Register
- FDA Medical Device Recalls (openFDA)
- Publisher
- U.S. Food and Drug Administration (openFDA)
- File
- device-recall-0001-of-0001.json.zip
- sha256
- b87518bfe2e8
- Size
- 288210821 bytes
- Published
- 2026-09-28
- Read
- 2026-09-29T08:25:23.626Z
- Source file
- Source file retained · verify
- Refresh due
- 2026-10-06
Unless otherwise noted, the content, data, documentation, code, and related materials on openFDA is public domain and made available with a Creative Commons CC0 1.0 Universal dedication.
Cite as
FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28