Tri-Staple 2 — Class II medical device recall Z-1228-2023
Ongoing recall by Covidien, LP, reported 2023-03-15, distributed nationwide. Affected lots have the potential for a broken sled vane, which may cause the reload to misfire leading to non-
| Recall number | Z-1228-2023 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Ongoing |
| Voluntary or mandated | Voluntary |
| Recalling firm | Covidien, LP, North Haven, CT, United States |
| Recall initiated | 2023-01-25 |
| Classified | 2023-03-06 |
| Reported by FDA | 2023-03-15 |
| Distributed | Nationwide (US) |
| Countries outside the US | AT, AU, BE, CA, CH, DE, DK, ES, FI, FR, GB, IE, IT, KW, NL, NO, PL, PT, SE |
| UPC / GTIN / UDI-DI | 20884521543598 |
| Lot numbers | N2D0002Y, N2D0004Y, N2D0195Y |
Product
Tri-Staple 2.0 Black Intelligent Reload, Product Number SIG60AXT
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.
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/Z-1228-2023. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.