Tri-Staple 2 — Class II medical device recall Z-2516-2018
Ongoing recall by COVIDIEN MEDTRONIC, reported 2018-07-25, distributed nationwide. Device may be missing a sled component. The sled component is responsible for staple deployment. This may resu
| Recall number | Z-2516-2018 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Ongoing |
| Voluntary or mandated | Voluntary |
| Recalling firm | COVIDIEN MEDTRONIC, NORTH HAVEN, CT, United States |
| Recall initiated | 2018-05-22 |
| Classified | 2018-07-19 |
| Reported by FDA | 2018-07-25 |
| Distributed | Nationwide (US) |
| Countries outside the US | AE, AT, BE, BG, CH, CZ, DE, DK, DZ, EE, ES, FI, FR, GB, GR, HR, HU, IE, IL, IS, IT, JO, KW, LB, LU, LV, MA, MT, NL, NO, PK, PL, PT, RO, RS, SA, SE, SI, SK, TN, TR, ZA |
| Reason classes | packaging |
| Model numbers | EGIA30CTAV |
Product
Tri-Staple 2.0 Curved Tip Intelligent Reload for use with Signia stapling system , Item Code EGIA30CTAV
Reason for recall
Device may be missing a sled component. The sled component is responsible for staple deployment. This may result in failure to form a staple line when tissue is divided, leading to bleeding or leakage of luminal contents.
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-2516-2018. 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.