Z-1098-2025Class II

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

Name: Z-1098-2025 ETHIBOND EXCEL Polyester Suture, REF: 6664H, X425H, X872H, EH7491H. Not sold in US
Creator: Ethicon, LLC
Published: 2024-12-20
License: https://open.fda.gov/license/

Ethicon, Inc / initiated 2024-12-20 / Open, Classified / root cause: manufacturing process

FDA source

Ethicon, LLC began a recall of ETHIBOND EXCEL Polyester Suture, REF: 6664H, X425H, X872H, EH7491H. Not sold in US on 2024-12-20. FDA classified it as Class II and gives the reason as "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...". As of 2026-09-10, the recall status on record is Open, Classified, and MDM tags the root cause as manufacturing process.

Recall record

Recall number: Z-1098-2025
Classification: Class II
Status: Open, Classified
Initiated: 2024-12-20
Posted: 2025-02-04
Recalling firm: Ethicon, Inc
Product: ETHIBOND EXCEL Polyester Suture, REF: 6664H, X425H, X872H, EH7491H. Not sold in US
Product code: GAW Suture, Nonabsorbable, Synthetic, Polypropylene
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.
Root cause tag: manufacturing process
FDA 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 [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.
Quantity in commerce: 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.
Product codes and lots: REF/GTIN/Lot(expiration): W8003T/10705031231658/103GT2(8/31/2029)

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-1098-2025
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-1096-2025	Class II	Ongoing	Voluntary: Firm initiated	2025-02-12	2025-02-04
Z-1097-2025	Class II	Ongoing	Voluntary: Firm initiated	2025-02-12	2025-02-04
Z-1098-2025	Class II	Ongoing	Voluntary: Firm initiated	2025-02-12	2025-02-04

Product code GAW

The FDA recall record names no cleared device, and no clearance has been matched to it.

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)