Ethicon, LLC: Device Recall
Recall #Z-1098-2025 · 12/20/2024
Class II: Risk
Recall Details
- Recall Number
- Z-1098-2025
- Classification
- Class II
- Product Type
- Device
- Recalling Firm
- Ethicon, LLC
- Status
- Ongoing
- Date Initiated
- 12/20/2024
- Location
- San Lorenzo, PR, United States
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 48
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.
Product Description
ETHIBOND EXCEL Polyester Suture, REF: 6664H, X425H, X872H, EH7491H. Not sold in US
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.
Other Recalls by Ethicon, LLC
- Class II: Risk 08/15/2025
- Class II: Risk 12/20/2024
- Class II: Risk 12/20/2024
Data from FDA openFDA enforcement reports. This site is not affiliated with or endorsed by the FDA. Recall information may be updated by the FDA at any time.