EGIA 30 ARTICULATING MED THICK SULU — Class II medical device recall Z-1825-2019
Ongoing recall by Covidien LLC, reported 2019-06-26, distributed nationwide. The device may be missing one of two pin components that maintain alignment of the device jaws, resulting in i
| Recall number | Z-1825-2019 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Ongoing |
| Voluntary or mandated | Voluntary |
| Recalling firm | Covidien LLC, North Haven, CT, United States |
| Recall initiated | 2019-05-17 |
| Classified | 2019-06-15 |
| Reported by FDA | 2019-06-26 |
| Distributed | Nationwide (US) |
| Quantity | 3,113,280 |
| Reason classes | packaging |
| Lot numbers | N5A0871KX, N7A0527KX, N7E0441KX, N8J0039KX, N8J0527KX, N8J0820KX |
| Model numbers | EGIA30AMT |
Product
EGIA 30 ARTICULATING MED THICK SULU, Item Code EGIA30AMT
Reason for recall
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.
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/Z-1825-2019. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.