ETHIBOND EXCEL ETHIBOND Polvester Suture-Green 75cm USP1 Single Armed… — Class II medical device recall Z-1842-2019
Terminated recall by Ethicon, Inc., reported 2019-06-26, distributed nationwide. Possibility that a suture raw material containing high endotoxin levels was used in the manufacturing of this
| Recall number | Z-1842-2019 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Ethicon, Inc., Somerville, NJ, United States |
| Recall initiated | 2019-04-19 |
| Classified | 2019-06-18 |
| Reported by FDA | 2019-06-26 |
| Terminated | 2021-02-05 |
| Distributed | Nationwide (US) |
| Countries outside the US | CA |
| Quantity | 36 eaches |
| Reason classes | sterility |
| Lot numbers | PBQ797 |
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 for recall
Possibility that a suture raw material containing high endotoxin levels was used in the manufacturing of this lot
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-1842-2019. 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.