Ethicon recalls specific ETHIBOND EXCEL polyester sutures (REF: 6664H, X425H, X872H, EH7491H) sold outside the US due to potential packaging breaches that could cause infections.
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.
Ethicon is recalling specific ETHIBOND EXCEL polyester sutures sold outside the US because their packaging might have an open seal, risking infection if used. This recall does not affect products sold in the United States.
The sutures may have an open seal on the primary packaging due to a manufacturing issue. If undetected, this breach could introduce pathogens to the patient during surgery, leading to infection.
Healthcare professionals and surgical teams who use the recalled sutures outside the US. Patients undergoing surgery with these sutures are at risk of infection if the packaging breach occurs.
Check for the product codes: REF 6664H, X425H, X872H, or EH7491H. These sutures were not sold in the United States, so US users are unaffected.
Look for the specific reference codes: 6664H, X425H, X872H, or EH7491H on the packaging.
No, these sutures were not sold in the United States.
If the packaging has an open seal, it could introduce pathogens during surgery, leading to infection.
Check for the reference codes: 6664H, X425H, X872H, or EH7491H on the packaging.
We’ve drafted a message you can send Ethicon to request your refund or repair — edit it as you like.
Subject: Recall Z-1098-2025 — Ethicon Ethicon Hello, I own a Ethicon that is covered by recall Z-1098-2025 from Ethicon. I’m writing to arrange the remedy described in the recall (a refund, repair, or replacement as applicable). Could you please tell me the next steps to resolve this? Thank you.
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The facts (hazard, remedy, dates, manufacturer) are pulled from the official FDA recall record. The plain-language summary and step-by-step checklist are written by GovInfoNow to make the official notice easier to act on — they don’t replace it.
