Ethicon recalls specific PROLENE Polypropylene Suture models due to potential open packaging that could breach sterility and cause infections. Affected items include REF: EH7585H, 8706H, 8833H, 8963H, 8935H with expiration dates through August 2029.
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 PROLENE Polypropylene Suture models because some packages may have an open seal, which could lead to contamination and infection during medical procedures. This is a serious risk for patients undergoing surgery.
The sutures may have an open seal on the primary packaging due to a manufacturing issue. If undetected, this could breach sterility, introducing pathogens to the patient and causing infections during medical procedures.
Medical professionals using these sutures for surgeries, particularly in cardiovascular, ophthalmic, or neurosurgical procedures. Patients undergoing surgery with these sutures are at risk of infection.
Check the product reference codes: EH7585H, 8706H, 8833H, 8963H, or 8935H. These sutures were sold with expiration dates through August 2029.
Look for reference codes EH7585H, 8706H, 8833H, 8963H, or 8935H on the packaging.
If the packaging has an open seal, it could breach sterility and introduce pathogens, leading to infections during surgery.
Check the reference codes on the packaging: EH7585H, 8706H, 8833H, 8963H, or 8935H with expiration dates through August 2029.
The recall does not require immediate discontinuation; medical professionals should check for open seals before use.
We’ve drafted a message you can send Ethicon to request your refund or repair — edit it as you like.
Subject: Recall Z-1096-2025 — Ethicon Ethicon Hello, I own a Ethicon that is covered by recall Z-1096-2025 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.
