FDA Medical Device Recalls (openFDA)
Ethicon, Inc.: 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
- Recall number
- Z-1842-2019
- Recalling firm
- Ethicon, Inc.
- 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
- Status
- Terminated
- Initiated
- 2019-04-19
- Posted
- not on file
- Terminated
- 2021-02-05
- Reason
- Possibility that a suture raw material containing high endotoxin levels was used in the manufacturing of this lot
- Root cause
- Material/Component Contamination
- Action
- Ethicon notified primary and secondary US consignees by telephone on 4/19/19 and follow-up letter dated April 24, 2019 stating reason for recall, health risk and action to take: examine inventory, remove product for return. Complete the Business Reply Form (BRF) to Stericycle at 1-844-721-3045 or ethicon5905@stericycle.com. Questions regarding this action or to report any customer complaints, please contact your Ethicon sales representative or contact Ethicon Customer Support Center at 1-877-ETHICON (1-877-384-4266). The Customer Support Center is open Monday through Friday, 8:00 AM to 6:00 PM ET.
- Quantity
- 36 eaches
- Distribution
- Worldwide - US Nationwide Distribution - IA, NJ, RI, TX, WV Foreign: Canada
- Lot, serial or model codes
- Lot Code:PBQ797
- 510(k) numbers
- ["K946173"]
- PMA numbers
- not on file
- Product code
- GAQ
- Firm FEI
- 2210968
- Firm city
- Somerville
- Firm state
- NJ
- Firm country
- not on file
Where this comes from
- Register
- FDA Medical Device Recalls (openFDA)
- Publisher
- U.S. Food and Drug Administration (openFDA)
- File
- device-recall-0001-of-0001.json.zip
- sha256
- b87518bfe2e8
- Size
- 288210821 bytes
- Published
- 2026-09-28
- Read
- 2026-09-29T08:25:23.626Z
- Source file
- Source file retained · verify
- Refresh due
- 2026-10-06
Unless otherwise noted, the content, data, documentation, code, and related materials on openFDA is public domain and made available with a Creative Commons CC0 1.0 Universal dedication.
Cite as
FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28