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Open, Classified

ETHIBOND EXCEL Polyester Suture, REF: 6664H, X425H, X872H, EH7491H. Not sold in US

FDA Recall Z-1098-2025 · Posted 2025-02-04

Recalling FirmEthicon, LLC
Recall StatusOpen, Classified
Product CodeGAW
Date Initiated2024-12-20
Product Quantity48

Reason for Recall

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.

Firm Action

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 [email protected] 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.

Root Cause

Process control

Distribution Pattern

Worldwide - US Nationwide distribution including in the states of AL, AR, AZ, CA, CT, DE, FL, GA, HI, IA, ID, IL, IN, KS, LA MA, MD, MI, MN, MO, MS, MT, NC, NE, NH, NJ, NV, NY, OH, OK, OR, PA, SC, SD, TN, TX, UT, VA, WA, WI and the countries of AT, AU, BE, CA, CH, CN, CZ, DE, DK, FI, FR, GB, HU, IE, JP, LU, NL, NO, PL, SE, SG, ZA.

Official Source

View FDA Recall →

Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.

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