FDA Device recall Z-1836-2019
SIGNIA TRI-STAPLE 2.0 CURVED TIP 60MM MEDIUM/ THIC , SIG60CTAMT
- FDA Device
- Class II
- ongoing
- Published 2019-06-26
On 2019-06-26 the FDA classified a Class II recall of SIGNIA TRI-STAPLE 2.0 CURVED TIP 60MM MEDIUM/ THIC , SIG60CTAMT by Covidien, citing the device may be missing one of two pin components that maintain alignment of the device jaws, resulting in incomplete staple formation which may lead to bleeding, anastomotic le….
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-1836-2019 |
| Classification | Class II |
| Status | ongoing |
| Initiated | 2019-05-17 |
| Published | 2019-06-26 |
| Last updated | 2026-09-13 11:55 UTC |
| Company | Covidien |
| Distribution | US |
Product
SIGNIA TRI-STAPLE 2.0 CURVED TIP 60MM MEDIUM/ THIC , SIG60CTAMT
Reason
The device may be missing one of two pin components that maintain alignment of the device jaws, resulting in incomplete staple formation which may lead to bleeding, anastomotic leak, peritonitis, or pneumothorax which can result in the potential for infection and/or sepsis.
Identifiers
| code_info | N6E0295UX N6H0576UX N6J1092UX N6K0230UX N6K0938UX N6L0422URX N6L0777UX N6M0607UX N7A0415UX N7C0112X N7D1013X…N6E0295UX N6H0576UX N6J1092UX N6K0230UX N6K0938UX N6L0422URX N6L0777UX N6M0607UX N7A0415UX N7C0112X N7D1013X N7E1089X N7F0275X N7F1126X N7G0444X N7H0047X N7H1067X N7J0175X N7L0825X N8A0249X N8A0655X N8B0455X N8B0945X N8C0757X N8C1213X N8D0593X N8D0907X N8E0015X N8G0648X N8J0764X N8K0823KY N8K0840Y N8L0166Y N8L0436Y N8M0845Y N9A0204Y N9B0455Y |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:55 UTC. Current status: ongoing.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-1836-2019%22
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