FDA Medical Device Recalls (openFDA)
Ethicon, LLC: ETHIBOND EXCEL Polyester Suture, REF: 6664H, X425H, X872H, EH7491H. Not sold in US
- Recall number
- Z-1098-2025
- Recalling firm
- Ethicon, LLC
- Product
- ETHIBOND EXCEL Polyester Suture, REF: 6664H, X425H, X872H, EH7491H. Not sold in US
- Status
- Open, Classified
- Initiated
- 2024-12-20
- Posted
- 2025-02-04
- Terminated
- not on file
- Reason
- 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.
- Root cause
- Process control
- 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 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.
- Quantity
- 48
- Distribution
- 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.
- Lot, serial or model codes
- REF/GTIN/Lot(expiration): W8003T/10705031231658/103GT2(8/31/2029)
- 510(k) numbers
- not on file
- PMA numbers
- not on file
- Product code
- GAW
- Firm FEI
- 2648650
- Firm city
- San Lorenzo
- Firm state
- not on file
- Firm country
- PR
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