Ethicon, Inc.: Medical Device Recall in 2019 - (Recall #: Z-1136-2019)

Updated on March 25, 2026.

See the recall detail below. You can also see other recalls from the same firm in 2019.

Data Source: FDA.

Product Description:

PDS II SUTURE 18"(45CM) 2-0 VIO Product Code:Z739D - PDS Sutures are intended for use in soft tissue approximation, including use in pediatric cardiovascular tissue where growth is expected to occur and ophthalmic surgery. PDS II suture is not indicated in adult cardiovascular tissue, microsurgery and neural tissue. These sutures are particularly useful where the combination of an absorbable suture and extended wound support (up to six weeks) is desirable

Product Classification:

Class II

Date Initiated: March 12, 2019

Date Posted: April 24, 2019

Recall Number: Z-1136-2019

Event ID: 82420

Reason for Recall:

VICRYL Suture, VICRYL Plus Suture, PDS Suture- may contain product that does not match the sales unit carton and foil label.

Status: Terminated

Product Quantity: 550,681 eaches (WW) Total

Code Information:

Lot Code: MGM110

Distribution Pattern:

Worldwide distributions - US Nationwide and countries of AUSTRALIA BELGIUM CANADA CHINA ISRAEL JAPAN PUERTO RICO SINGAPORE

Voluntary or Mandated:

Voluntary: Firm initiated