FDA Device recall Z-1842-2019
ETHIBOND EXCEL ETHIBOND Polvester Suture-Green 75cm USP1 Single Armed CTX Product Code: X865W Product Usage: ETHIBOND EXCEL Suture is inten…
- FDA Device
- Class II
- terminated
- Published 2019-06-26
On 2019-06-26 the FDA classified a Class II recall of ETHIBOND EXCEL ETHIBOND Polvester Suture-Green 75cm USP1 Single Armed CTX Product Code: X865W Product Usage: ETHIBOND EXCEL Suture is inten… 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-1842-2019 |
| 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 ETHIBOND Polvester Suture-Green 75cm USP1 Single Armed CTX Product Code: X865W 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:PBQ797 |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:55 UTC. Current status: terminated.
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FDA Device · Class II · 2026-10-21 · Ethicon - STRATAFIX Spiral PDS Plus Bidirectional Knotless Tissue Control Device, SFX SPI PDS+ BI VIO 14X14IN(36X36CM) USP1(M4) D/A MO-4. Product Cod…
FDA Device · Class II · 2025-10-01 · Ethicon - PERMA-HAND Silk Suture, REF: K872H, W723H, 623H, K833H
FDA Device · Class II · 2025-02-12 · Ethicon - ETHIBOND EXCEL Polyester Suture, REF: 6664H, X425H, X872H, EH7491H. Not sold in US
FDA Device · Class II · 2025-02-12 · Ethicon - PROLENE Polypropylene Suture, REF: EH7585H, 8706H, 8833H, 8963H, 8935H PROLENE Suture is indicated for use in general soft tissue approxima…
FDA Device · Class II · 2025-02-12 · Ethicon
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-1842-2019%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.