FDA Device recall Z-1831-2019
EGIA45 CT AR MD THK REL, EGIA45CTAMT
- FDA Device
- Class II
- ongoing
- Published 2019-06-26
On 2019-06-26 the FDA classified a Class II recall of EGIA45 CT AR MD THK REL, EGIA45CTAMT 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-1831-2019 |
| 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
EGIA45 CT AR MD THK REL, EGIA45CTAMT
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 | N8L0401KY |
|---|
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-1831-2019%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.