Tri-Staple 2.0 Reload (Unknown) – cartridge damage risk (2024)
Cartridge damage can cause poor staple formation during surgical procedures.
This AI-generated summary is provided for general informational purposes only and is derived from publicly available recall notices. It supplements but does not replace official agency classifications or safety instructions.
Check Your Product
According to the U.S. Food and Drug Administration (FDA)
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
Lot Codes / Batch Numbers
GTIN: 10884521717633 20884521717630 Lot #: N3G1372Y
Products Sold
GTIN: 10884521717633 20884521717630 Lot #: N3G1372Y
A medical device manufacturer is recalling Tri-Staple 2.0 Black Reinforced Intelligent Reload- Applications in abdominal, gynecologic, pediatri due to Potential damage to the cartridge can result in poor staple formation and/or incomplete staple line, may cause a delay in surgery. Based on FDA medical device recall database.
Summary derived from FDA notice
Reason for Recall
As stated by FDA
Potential damage to the cartridge can result in poor staple formation and/or incomplete staple line, may cause a delay in surgery
Recommended Action
Per FDA guidance
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.
Verify this information on the official source
For complete details and official instructions, check the U.S. Food and Drug Administration (FDA) directly.
View official FDA recall noticePage updated: Jan 10, 2026