Signia" Power Handle — Class II medical device recall Z-1237-2018
Terminated recall by Covidien LLC, reported 2018-04-04, distributed nationwide. Product reportedly shutting down during use.
| Recall number | Z-1237-2018 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Covidien LLC, North Haven, CT, United States |
| Recall initiated | 2017-12-13 |
| Classified | 2018-03-27 |
| Reported by FDA | 2018-04-04 |
| Terminated | 2020-04-14 |
| Distributed | Nationwide (US) |
| Quantity | 2,121 |
| UPC / GTIN / UDI-DI | 10884521543782 |
| Serial numbers | C17AAA0001, C17AAA0002, C17AAA0003, C17AAA0004, C17AAA0005, C17AAA0006, C17AAA0007, C17AAA0008, C17AAA0009, C17AAA0010, C17AAA0011, C17AAA0012, C17AAA0013, C17AAA0014, C17AAA0015, C17AAA0017, C17AAA0018, C17AAA0019, C17AAA0020, C17AAA0021, C17AAA0022, C17AAA0023, C17AAA0024, C17AAA0026, C17AAA0027 and 475 more |
Product
Signia" Power Handle (SIGPHANDLE, SIGNVAL1 and SIGVAL20 - Kits) The Signia" Power Handle, when used with Endo GIA" single-use reloads and Endo GIA" single-use reloads with Tri-Staple" Technology, has applications in open and minimally invasive general abdominal, gynecological, pediatric, and thoracic surgery for resection, transection, and creation of anastomosis.
Reason for recall
Product reportedly shutting down during use.
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-1237-2018. 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.