Ethicon, LLC: Medical Device Recall in 2025 - (Recall #: Z-1096-2025)

Updated on March 25, 2026.

See the recall detail below. You can also see other recalls from the same firm in 2025.

Data Source: FDA.

Product Description:

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.

Product Classification:

Class II

Date Initiated: December 20, 2024

Date Posted: February 12, 2025

Recall Number: Z-1096-2025

Event ID: 96127

Reason for Recall:

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.

Status: Ongoing

Product Quantity: 15,948

Code Information:

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)

Distribution Pattern:

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, MO, MS, MT, NC, NE, NH, NJ, NV, NY, OH, OK, OR, PA, SC, SD, TN, TX, UT, VA, WA, WI and the countries of AT, AU, BE, CA, CH, CN, CZ, DE, DK, FI, FR, GB, HU, IE, JP, LU, NL, NO, PL, SE, SG, ZA.

Voluntary or Mandated:

Voluntary: Firm initiated