Tri-Staple 2 — Class II medical device recall Z-1891-2024
Ongoing recall by Covidien, LP, reported 2024-06-05, distributed nationwide. Potential damage to the cartridge can result in poor staple formation and/or incomplete staple line, may cause
| Recall number | Z-1891-2024 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Ongoing |
| Voluntary or mandated | Voluntary |
| Recalling firm | Covidien, LP, North Haven, CT, United States |
| Recall initiated | 2024-04-15 |
| Classified | 2024-05-24 |
| Reported by FDA | 2024-06-05 |
| Distributed | Nationwide (US) |
| Countries outside the US | AU, JP, NZ, SA, SG, TH, TW, ZA |
| Quantity | 1,681 units |
| UPC / GTIN / UDI-DI | 10884521717633, 20884521717630 |
| Lot numbers | N3G1372Y |
| Model numbers | SIGTRSB60AXT |
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
Reason for recall
Potential damage to the cartridge can result in poor staple formation and/or incomplete staple line, may cause a delay in surgery
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-1891-2024. 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.