Potential health hazard — use of or exposure to this product may cause temporary or medically reversible adverse health consequences.
PROLENE Polypropylene Suture Recalled by Ethicon, LLC Due to Sutures may have an open seal on the...
What You Should Do
Stop using this product immediately. Do not consume, use, or distribute it.
Return the product to the place of purchase for a full refund. If you have questions, contact Ethicon, LLC directly.
Affected Products
PROLENE Polypropylene Suture, REF: EH7585H, 8706H, 8833H, 8963H, 8935H PROLENE Suture is indicated for use in general soft tissue approximation and/or ligation, including use in cardiovascular, ophthalmic, and neurosurgical procedures.
Quantity: 15,948
Why Was This Recalled?
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.
Where Was This Sold?
This product was distributed nationwide across all 50 states.
About Ethicon, LLC
Ethicon, LLC has 3 total recalls tracked by RecallDetector.
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Data sourced from the FDA (Device). Last updated March 26, 2026. View original report