ETHIBOND EXCEL Polyester Suture — Class II medical device recall Z-1098-2025
Ongoing recall by Ethicon, LLC, reported 2025-02-12, distributed nationwide. Sutures may have an open seal on the primary packaging, due to a manufacturing issue on a specific machine, an
| Recall number | Z-1098-2025 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Ongoing |
| Voluntary or mandated | Voluntary |
| Recalling firm | Ethicon, LLC, San Lorenzo, PR, United States |
| Recall initiated | 2024-12-20 |
| Classified | 2025-02-04 |
| Reported by FDA | 2025-02-12 |
| Distributed | Nationwide (US) |
| Quantity | 48 |
| Reason classes | microbial contamination, sterility, packaging |
| UPC / GTIN / UDI-DI | 10705031231658 |
| Model numbers | 6664H, EH7491H, X425H, X872H |
Product
ETHIBOND EXCEL Polyester Suture, REF: 6664H, X425H, X872H, EH7491H. Not sold in US
Reason for recall
Sutures may have an open seal on the primary packaging, due to a manufacturing issue on a specific machine, and if issue is undetected could lead to breach in sterility, could introduce pathogens to the patient and cause infection.
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-1098-2025. 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.