FDA Device recall Z-1825-2019
EGIA 30 ARTICULATING MED THICK SULU, Item Code EGIA30AMT
- FDA Device
- Class II
- ongoing
- Published 2019-06-26
On 2019-06-26 the FDA classified a Class II recall of EGIA 30 ARTICULATING MED THICK SULU, Item Code EGIA30AMT 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-1825-2019 |
| 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 30 ARTICULATING MED THICK SULU, Item Code EGIA30AMT
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 N5A0871KX N7A0527KX N7E0441KX N8J0039KX N8J0527KX N8J0820KX |
|---|
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-1825-2019%22
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