FDA Device recall Z-1098-2025
ETHIBOND EXCEL Polyester Suture, REF: 6664H, X425H, X872H, EH7491H. Not sold in US
- FDA Device
- Class II
- ongoing
- Published 2025-02-12
On 2025-02-12 the FDA classified a Class II recall of ETHIBOND EXCEL Polyester Suture, REF: 6664H, X425H, X872H, EH7491H. Not sold in US by Ethicon, citing 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 int….
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-1098-2025 |
| Classification | Class II |
| Status | ongoing |
| Initiated | 2024-12-20 |
| Published | 2025-02-12 |
| Last updated | 2026-09-13 11:57 UTC |
| Company | Ethicon |
| Distribution | US |
Product
ETHIBOND EXCEL Polyester Suture, REF: 6664H, X425H, X872H, EH7491H. Not sold in US
Reason
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.
Identifiers
| code_info | REF/GTIN/Lot(expiration): W8003T/10705031231658/103GT2(8/31/2029) |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:57 UTC. Current status: ongoing.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-1098-2025%22
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