Ethicon, LLC recalls ETHIBOND EXCEL Polyester Suture

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.

On 12/20/2024, Johnson & Johnson Med Tech mailed recall notices to Operating Room Supervisors, Materials Management Personnel, Chief of Surgery, and distributors who were asked to do the following: 1) Examine your inventory immediately to determine if you have product subject to this recall on hand and quarantine such product(s). 2) Communicate the issue to relevant operating room or materials management personnel, or anyone else in your facility who needs to be informed. If any product subject to this recall has been forwarded to another facility, contact that facility to arrange return. Please consider including a copy of this recall letter when communicating. 3) Contact Sedgwick at 888-548-8526 to arrange affected product return. 4) Keep this notice visibly posted for awareness until all product subject to this recall has been returned to Sedgwick. 5) Complete and return the Business Reply Form via email to ethicon3703@sedgwick.com If you have additional questions regarding this communication contact the firm's Resource Department at 1-877-ETHICON (1-877-384-4266) open Monday through Friday, 8:00 AM to 5:00 PM ET.

• FDA enforcement recordOfficial FDA database entry for Z-1098-2025
• FDA device classification · GAWOfficial FDA classification for this device type
• CFR regulation · 21 CFR 878.5010The federal regulation governing this device
• FDA recall announcementSearch FDA.gov for the official press announcement
• Find Ethicon, LLCSearch for the manufacturer's official notice
• News coverageRecent reporting on this recall and manufacturer
• openFDA data recordThe raw JSON record this page is built from

Source: U.S. FDA openFDA device enforcement reports. This summary is informational and may lag or differ from the official record. Always verify against the FDA before acting.