Ethicon, Inc.: Medical Device Recall in 2018 - (Recall #: Z-2461-2018)

Updated on March 25, 2026.

See the recall detail below. You can also see other recalls from the same firm in 2018.

Data Source: FDA.

Product Description:

PROLENE SUTURE BLUE 48" 4-0 D/A SH-1, D9746

Product Classification:

Class II

Date Initiated: May 7, 2018

Date Posted: July 25, 2018

Recall Number: Z-2461-2018

Event ID: 80306

Reason for Recall:

The needle associated with certain suture product codes has the potential to perforate the packaging due to a packaging design issue. A perforated package has the potential to cause a soft tissue injury to a healthcare professional handling the subject product or a patient infection due to a breach of sterility within the packaging if it goes unnoticed by the healthcare professional.

Status: Terminated

Product Quantity: 4440

Code Information:

KDH782 KEH344 KEJ158 KGJ668 KGQ354 KJE929 KJH424 KKJ658 LAB267 LCH376 LCH571 LEB803 LGB860 LKR893 LPJ096 LPP510 MCJ449 MCQ993

Distribution Pattern:

Accounts in AZ, CA, CO, FL, GA, IL, IN, KS, MA, MN, MO, NC, NE, NJ, NY, OH, OR, SC, SD, TN, TX, VA, WA, WI, WV.

Voluntary or Mandated:

Voluntary: Firm initiated