Covidien Signia Small Diameter Curved Tip Intelligent Reload 30 mm… — Class II medical device recall Z-1385-2021
Terminated recall by Covidien, LP, reported 2021-04-21, distributed nationwide. Potential for the device safety interlock to fail. The safety interlock prevents an empty single-use reload fr
| Recall number | Z-1385-2021 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Covidien, LP, North Haven, CT, United States |
| Recall initiated | 2021-03-04 |
| Classified | 2021-04-09 |
| Reported by FDA | 2021-04-21 |
| Terminated | 2024-07-12 |
| Distributed | Nationwide (US) |
| Countries outside the US | AT, BE, CH, CL, CN, DE, DK, ES, FI, FR, GB, HK, IE, IT, NL, NO, PL, PT, SE |
| UPC / GTIN / UDI-DI | 10884521741874, 20884521741871 |
| Lot numbers | N0A0274UY, N0A0897UY, N0B0640UY, N0B0937UY, N0C0144UY, N0C0486UY, N0C1115UY, N0D0037UY, N0D0391UY, N0E0175UY, N0E0802UY, N0F1055UY, N0G0185UY, N0G0250UY, N0G0491UY, N0G0736UY, N0J0510UY, N0J0680UY, N0J0999UY, N0K0584UY, N0K0805UY, N0K1016UY, N0L0077UY, N0M0063UY, N0M0259UY, N9K1094UY, N9L0795UY |
| Model numbers | SIGSDS30CTVT |
Product
Covidien Signia Small Diameter Curved Tip Intelligent Reload 30 mm Vascular/Thin 8 mm - Short Item Code:SIGSDS30CTVT
Reason for recall
Potential for the device safety interlock to fail. The safety interlock prevents an empty single-use reload from being erroneously fired a second time. If the safety interlock fails and the empty single-use reload is fired a second time, the stapler may cut tissue but no staples will deploy from the empty reload, potentially resulting in a failed anastomosis, bleeding, tissue trauma, and the potential need to convert to an open procedure.
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-1385-2021. 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.