FDA Device recall Z-1841-2019
ETHIBOND EXCEL¿ Polyester Suture-ETHIBOND Green 75cm USP1 Single Armed CT-1 Product Code: X425H Product Usage: ETHIBOND EXCEL Suture is int…
- FDA Device
- Class II
- terminated
- Published 2019-06-26
On 2019-06-26 the FDA classified a Class II recall of ETHIBOND EXCEL¿ Polyester Suture-ETHIBOND Green 75cm USP1 Single Armed CT-1 Product Code: X425H Product Usage: ETHIBOND EXCEL Suture is int… by Ethicon, citing possibility that a suture raw material containing high endotoxin levels was used in the manufacturing of this lot.
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-1841-2019 |
| Classification | Class II |
| Status | terminated |
| Initiated | 2019-04-19 |
| Published | 2019-06-26 |
| Last updated | 2026-09-13 11:55 UTC |
| Company | Ethicon |
| Distribution | US |
Product
ETHIBOND EXCEL¿ Polyester Suture-ETHIBOND Green 75cm USP1 Single Armed CT-1 Product Code: X425H Product Usage: ETHIBOND EXCEL Suture is intended for use in general soft tissue approximation and/or ligation, including use in cardiovascular, ophthalmic and neurological procedures
Reason
Possibility that a suture raw material containing high endotoxin levels was used in the manufacturing of this lot
Identifiers
| code_info | Lot Code: PBQ426 |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:55 UTC. Current status: terminated.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-1841-2019%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.