PROLENE Polypropylene Suture (Ethicon) – Packaging Seal Issue (2024)
Check Your Product
According to the U.S. Food and Drug Administration (FDA)
Product
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.
Brand
Ethicon, LLC
Lot Codes / Batch Numbers
REF/UDI-DI-GTIN/Lot(expiration): EH7585H/10705031097254/103DQR(8/31/2029), 8706H/10705031019430/103E22(8/31/2029), 103EMJ(8/31/2029), 8833H/10705031021037/103HC4(8/31/2029), 8963H/10705031091931/103E8Z(8/31/2029), 8935H/10705031022089/103HBP(8/31/2029)
Products Sold
REF/UDI-DI-GTIN/Lot(expiration): EH7585H/10705031097254/103DQR(8/31/2029); 8706H/10705031019430/103E22(8/31/2029), 103EMJ(8/31/2029); 8833H/10705031021037/103HC4(8/31/2029); 8963H/10705031091931/103E8Z(8/31/2029); 8935H/10705031022089/103HBP(8/31/2029)
Ethicon, LLC is recalling PROLENE Polypropylene Suture, REF: EH7585H, 8706H, 8833H, 8963H, 8935H PROLENE Suture is indicated f due to 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 b. Based on FDA medical device recall database.
Summary derived from FDA notice
Reason for Recall
As stated by FDA
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.
Recommended Action
Per FDA guidance
On 12/20/2024, Johnson & Johnson Med Tech mailed recall notices to Operating Room Supervisors, Materials Management Personnel, Chief of Surgery, and distributors who were asked to do the following: 1) Examine your inventory immediately to determine if you have product subject to this recall on hand and quarantine such product(s). 2) Communicate the issue to relevant operating room or materials management personnel, or anyone else in your facility who needs to be informed. If any product subject to this recall has been forwarded to another facility, contact that facility to arrange return. Please consider including a copy of this recall letter when communicating. 3) Contact Sedgwick at 888-548-8526 to arrange affected product return. 4) Keep this notice visibly posted for awareness until all product subject to this recall has been returned to Sedgwick. 5) Complete and return the Business Reply Form via email to ethicon3703@sedgwick.com If you have additional questions regarding this communication contact the firm's Resource Department at 1-877-ETHICON (1-877-384-4266) open Monday through Friday, 8:00 AM to 5:00 PM ET.
Verify this information on the official source
For complete details and official instructions, check the U.S. Food and Drug Administration (FDA) directly.
View official FDA recall noticePage updated: Jan 10, 2026