Ethicon, Inc.: Medical Device Recall in 2018 - (Recall #: Z-2453-2018)

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 36"(90CM) 4-0 BLUE, D7768

Product Classification:

Class II

Date Initiated: May 7, 2018

Date Posted: July 25, 2018

Recall Number: Z-2453-2018

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: 15180

Code Information:

KDH099 KDJ422 KDJ564 KEB962 KEE491 KEE541 KKH770 KKJ554 KKJ555 KKJ688 KMB434 KMP958 KPH281 KPP708 KPP709 LBJ626 LCH208 LDH331 LEP836 LGB696 LGP653 LHB978 LHH617 LJE597 LKH051 LMH352 LPJ187 LPJ672 LPP509 MCJ330 MCJ448 MDH289 MCQ533

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