Ethicon, Inc.: Medical Device Recall in 2018 - (Recall #: Z-2533-2018)

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:

PDS Plus Antibacterial Suture-PDS PLUS Undyed Suture 45cm (18") 5-0 Single Armed P-3 Prime Needle Product Code: PDP493G (GTIN 10705031203945)

Product Classification:

Class II

Date Initiated: June 8, 2018

Date Posted: August 1, 2018

Recall Number: Z-2533-2018

Event ID: 80401

Reason for Recall:

Products do not meet a tensile strength specification

Status: Terminated

Product Quantity: 756

Code Information:

Lot Number:MCZ162

Distribution Pattern:

Japan

Voluntary or Mandated:

Voluntary: Firm initiated