FDA Device recall Z-1237-2018
Signia" Power Handle (SIGPHANDLE, SIGNVAL1 and SIGVAL20 - Kits) The Signia" Power Handle, when used with Endo GIA" single-use reloads and E…
- FDA Device
- Class II
- terminated
- Published 2018-04-04
On 2018-04-04 the FDA classified a Class II recall of Signia" Power Handle (SIGPHANDLE, SIGNVAL1 and SIGVAL20 - Kits) The Signia" Power Handle, when used with Endo GIA" single-use reloads and E… by Covidien, citing product reportedly shutting down during use.
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-1237-2018 |
| Classification | Class II |
| Status | terminated |
| Initiated | 2017-12-13 |
| Published | 2018-04-04 |
| Last updated | 2026-09-13 11:54 UTC |
| Company | Covidien |
| Distribution | US |
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
Product reportedly shutting down during use.
Identifiers
| code_info | SIGPHANDLE-UDI #10884521543782 Serial# C17AAA0001 C17AAA0002 C17AAA0003 C17AAA0004 C17AAA0005 C17AAA0006 C17AAA…SIGPHANDLE-UDI #10884521543782 Serial# 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 C17AAA0028 C17AAA0029 C17AAA0030 C17AAA0031 C17AAA0032 C17AAA0033 C17AAA0034 C17AAA0035 C17AAA0036 C17AAA0037 C17AAA0038 C17AAA0039 C17AAA0040 C17AAA0042 C17AAA0043 C17AAA0044 C17AAA0045 C17AAA0046 C17AAA0047 C17AAA0048 C17AAA0049 C17AAA0050 C17AAA0051 C17AAA0052 C17AAA0053 C17AAA0054 C17AAA0055 C17AAA0056 C17AAA0057 C17AAA0058 C17AAA0059 C17AAB0002 C17AAB0003 C17AAB0004 C17AAB0005 C17AAB0006 C17AAB0007 C17AAB0008 C17AAB0009 C17AAB0010 C17AAB0011 C17AAB0012 C17AAB0013 C17AAB0014 C17AAB0015 C17AAB0016 C17AAB0017 C17AAB0018 C17AAB0019 C17AAB0020 C17AAB0021 C17AAB0022 C17AAB0023 C17AAB0024 C17AAB0025 |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:54 UTC. Current status: terminated.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-1237-2018%22
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