Covidien Signia" Small Diameter Curved Tip Intelligent Reload — Class II medical device recall Z-0485-2026
Ongoing recall by Covidien, LP, reported 2025-11-19, distributed nationwide. A manufacturing issue could lead to a malformed cover tube press which can lead to internal components' moveme
| Recall number | Z-0485-2026 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Ongoing |
| Voluntary or mandated | Voluntary |
| Recalling firm | Covidien, LP, North Haven, CT, United States |
| Recall initiated | 2025-09-25 |
| Classified | 2025-11-07 |
| Reported by FDA | 2025-11-19 |
| Distributed | Nationwide (US) |
| Countries outside the US | AT, BE, CL, DE, EE, ES, FI, FR, GB, GR, HU, IL, IT, JP, KW, MY, NL, PL, PT, RO, SA, SK |
| Quantity | 3,263 units |
| UPC / GTIN / UDI-DI | 10884521741843, 20884521741840 |
| Lot numbers | N5B1134UY, N5D1858UY, N5F1723Y, N5F1971Y |
Product
Covidien Signia" Small Diameter Curved Tip Intelligent Reload (45mm Vascular/Thin); CFN: SIGSDL45CTVT;
Reason for recall
A manufacturing issue could lead to a malformed cover tube press which can lead to internal components' movement during firing - leading to the potential for uncontrolled motion.
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-0485-2026. 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.