FDA Device recall Z-1228-2023
Tri-Staple 2.0 Black Intelligent Reload, Product Number SIG60AXT
- FDA Device
- Class II
- ongoing
- Published 2023-03-15
On 2023-03-15 the FDA classified a Class II recall of Tri-Staple 2.0 Black Intelligent Reload, Product Number SIG60AXT by Covidien, citing 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 st….
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-1228-2023 |
| Classification | Class II |
| Status | ongoing |
| Initiated | 2023-01-25 |
| Published | 2023-03-15 |
| Last updated | 2026-09-13 11:56 UTC |
| Company | Covidien |
| Distribution | US |
Product
Tri-Staple 2.0 Black Intelligent Reload, Product Number SIG60AXT
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.
Identifiers
| code_info | UDI-DI (GTIN): 20884521543598 Lots: N2D0002Y, N2D0004Y, N2D0195Y |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:56 UTC. Current status: ongoing.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-1228-2023%22
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