Reported Feb 12, 2025 · Ongoing
PROLENE Polypropylene Suture, REF: EH7585H, 8706H, 8833H, 8963H, 8935H PROLENE Suture is indicated for use in general…
Ethicon, LLC
Moderate riskThis product could cause temporary or reversible health problems — stop using it.What you should do
Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.
Firm contact: Ethicon, LLC · Highway 183 Km 8.3 · San Lorenzo, PR · 00754
Is this the product you have?
- PROLENE Polypropylene Suture
- REFEH7585H, 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
- Lot codes and dates
5 of 5 products · 6 lot codes
Recalled lot codes, grouped by product number REF UDI-DI-GTIN Lot (expiration) EH7585H10705031097254103DQR8/31/2029
8706H10705031019430103E228/31/2029103EMJ8/31/2029
8833H10705031021037103HC48/31/2029
8963H10705031091931103E8Z8/31/2029
8935H10705031022089103HBP8/31/2029
- Amount recalled
- 15,948
This recall covers 3 products
The agency filed one notice per product. You are reading one of them; the other 2 are below.
Where it was sold
Why it was 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.
This product could cause temporary or reversible health problems — stop using it.
Want the full recall guide?
The guide adds the identifying codes laid out for scanning, symptoms to watch for, a timeline, and news coverage of this recall.
Free recall alerts
Get alerted about new Ethicon, LLC recalls
One email when a matching recall is published. No account, no cost, unsubscribe in one click.
We email you about recalls and nothing else. Every send has a one-click unsubscribe, and you can change your preferences any time without an account.