FDA Device recall Z-1829-2019
EGIA 60 ARTICULATING MED THICK SULU , EGIA60AMT
- FDA Device
- Class II
- ongoing
- Published 2019-06-26
On 2019-06-26 the FDA classified a Class II recall of EGIA 60 ARTICULATING MED THICK SULU , EGIA60AMT 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-1829-2019 |
| 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
EGIA 60 ARTICULATING MED THICK SULU , EGIA60AMT
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 | N4C1545KX N4C1718KX N4D0042KX N4D0366KX N4D0453KX N4D0589KX N4D0605KX N4D0688KX N4D0814KX N4D0897KX N4D1145KX…N4C1545KX N4C1718KX N4D0042KX N4D0366KX N4D0453KX N4D0589KX N4D0605KX N4D0688KX N4D0814KX N4D0897KX N4D1145KX N4E1383KX N4E1505KX N4F0006KX N4F0076KX N4F0114KX N4F0516KX N4F0695KX N4F0719KX N4F0853KX N4F0929KX N4F0981KX N4F1092KX N4F1159KX N4F1163KX N4F1331KX N4F1383KX N4F1450KX N4F1542KX N4H0432KX N4H0475KX N4H0503KX N4J1170KX N4K0212KX N4K0742KX N4K0757KX N4K0835KX N4K0870KX N4L0249KX N4L0315KX N4M0982KX N4M1062KX N5A0286KX N5A0345KX N5A0364KX N5A1461KX N5B0031KX N5B0700KX N5B0757KX N5B0794KX N5B0856KX N5C0465KX N5C0639KX N5C0668KX N5C0725KX N5C0758KRX N5C0914KX N5C0986KX N5D0862KX N5E0348KX N5E1158KX N5E1213KX N5E1245KX N5F0181KX N5F0260KX N5F0330KX N5F0348KX N5G0114KX N5G0154KX N5G0186KX N5G0660KX N5G0877KX N5G0983KX N5G1011KX N5G1122KX N5G1147KX N5G1248KX N5H0100KX N5H0226KX N5H0250KX N5H0481KX N5H0623KX N5H0676KX N5H0730KX N5H0762KX N5H0838KX N5H0949KX N5H0970KX N5H0993KX N5H1013KX N5H1082KX |
|---|
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-1829-2019%22
RecallRadar indexes public recall notices from the FDA, USDA FSIS, and CPSC. The official agency notice is the authoritative source. Always confirm details at the linked source before acting.