FDA Device recall Z-1826-2019
EGIA 45 ARTICULATING MED THICK SULU, Item Code EGIA45AMT
- FDA Device
- Class II
- ongoing
- Published 2019-06-26
On 2019-06-26 the FDA classified a Class II recall of EGIA 45 ARTICULATING MED THICK SULU, Item Code EGIA45AMT 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-1826-2019 |
| 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 45 ARTICULATING MED THICK SULU, Item Code EGIA45AMT
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 | lots N4D0328KX N4D0338KX N4E0796KX N4E0846KX N4E0980KX N4E1018KX N4E1059KX N4E1173KX N4E1269KX N4E1654KX N4E1…lots N4D0328KX N4D0338KX N4E0796KX N4E0846KX N4E0980KX N4E1018KX N4E1059KX N4E1173KX N4E1269KX N4E1654KX N4E1655KX N4G0523KX N4G1541KX N4H0078KX N4J0215KX N4J0250KX N4J0271KX N4J1002KX N4J1217KX N4J1247KX N4K1465KX N4M0921KX N5B0285KX N5B0340KX N5B0417KX N5B0484KX N5B0680KX N5D0467KX N5D0497KX N5D0550KX N5D0609KX N5D0660KX N5D0736KX N5D0765KX N5D1008KX N5E0068KX N5E0143KX N5E0297KX N5E0727KX N5E0756KX N5F0096KX N5F1223KX N5F1382KX N5G0244KX N5G0329KX N5G0339KX N5G0355KX N5G0405KX N5G0414KX N5G0809KX N5G0868KX N5J1153KX N5J1201KX N5J1233KX N5K0045KX N5K0089KX N5K0115KX N5M0172KX N5M0662KX N5M0693KX N5M0732KX N5M0741KX N6A0913KX N6B0332KX N6C0462KX N6D0388KX N6D0474KX N6D0506KX N6E0078KX N6E0099KX N6E0117KX N6E0129KX N6E0366KX N6E0416KX N6F0039KX N6F0088KX N6F0156KX N6F0720KX N6F0780KX N6F0816KX N6G0099KX N6G0139KX N6G0191KX N6G0198KX N6G0213KX N6G0243KX N6G0280KX N6H0168KX N6H0247KX N6H0291KX N6H03 |
|---|
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-1826-2019%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.