Ethicon, LLC 2025-02-12 Health serious FDA
Health · FDA · Recall #FDA-Z-1096-2025
PROLENE Polypropylene Suture, REF: EH7585H, 8706H, 8833H, 8963H, 8935H PROLENE Suture is… Recall
Issued February 12, 2025 · Ethicon, LLC
In February 2025, Ethicon, LLC recalled the PROLENE Polypropylene Suture, REF: EH7585H, 8706H, 8833H, 8963H, 8935H PROLENE Suture is…, a serious health recall reported by the FDA.
Compiled by Maya Ellison, RecallCheckr
What this means for you
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.
What you should do
- 1 Stop using PROLENE Polypropylene Suture, REF: EH7585H, 8706H, 8833H, 8963H, 8935H PROLENE Suture is… right away.
- 2 Set it aside where it won't be used by mistake.
- 3 Contact Ethicon, LLC to arrange your voluntary. See the official notice below for contact details.
- 4 Keep the product until your remedy is fully processed. You may need it.
Official remedy (Voluntary):
Recall details
- Brand
- Ethicon, LLC
- Category
- Health
- Recall date
- February 12, 2025
- Units affected
- Not reported
- Sold at
- 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,
- Recall number
- FDA-Z-1096-2025
- Made in
- United States
- Issuing agency
- FDA
In context
- Ethicon, LLC has 1 recall in our database.
- We're tracking 3,576 Health recalls in our database.
- This is the 691st Health recall we've logged in 2025.