Ethicon, LLC: Medical Device Recall in 2025 - (Recall #: Z-1098-2025)

Updated on March 25, 2026.

See the recall detail below. You can also see other recalls from the same firm in 2025.

Data Source: FDA.

Product Description:

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

Product Classification:

Class II

Date Initiated: December 20, 2024

Date Posted: February 12, 2025

Recall Number: Z-1098-2025

Event ID: 96127

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.

Status: Ongoing

Product Quantity: 48

Code Information:

REF/GTIN/Lot(expiration): W8003T/10705031231658/103GT2(8/31/2029)

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.

Voluntary or Mandated:

Voluntary: Firm initiated